Lorinda Bullock

New data from the Centers for Disease and Control and Prevention reveal that nearly 1 in 10 U.S. adults met criteria for current depression. Women and nonwhites are at the greatest risk.

The CDC said in its Morbidity and Mortality Weekly Report, released Sept. 30, that by the year 2020, depression is expected to be second only to cardiovascular disease in disease burden. In 2004, depression was the third leading cause of disease burden worldwide and a leading cause of disability in high-income countries.

The CDC warned that depression can exacerbate chronic conditions such as arthritis, asthma, cardiovascular disease, cancer, diabetes, and obesity, all of which can contribute to increased work absenteeism, short-term disability, and decreased productivity.

Using Behavioral Risk Factor Surveillance System telephone survey data from 2006 and 2008 involving 235,067 adults aged 18 and older in 45 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, the CDC found that 9% met criteria for current depression, including 3.4% who met criteria for major depression (MMWR Morb. Mortal. Wkly. Rep. 2010;59:1229-35).

The criteria for current depression were based on the Patient Health Questionnaire 8. People were considered to have major depression if for “more than half the days” they met at least five of the eight criteria, including at least one of the following: “little interest or pleasure in doing things” or “feeling down, depressed, or hopeless.”

The report showed a significant difference in the prevalence of depression between men and women. Four percent of women reported major depression, compared with 2.7% of men. “The greater prevalence of depression among women is not fully understood, although potential contributors include different responses to stressful life events, genetic predisposition, and hormonal differences,” the report said.

Non-Hispanic blacks, Hispanics, and non-Hispanics of other races were all more likely to report major depression (4%, 4%, and 4.3%, respectively) than were non-Hispanic whites (3.1%). The researchers explained that this disparity is consistent with greater risk factors of mental illness in these populations stemming from “social and economic inequality, exposure to racism and discrimination, increased prevalence of some chronic diseases, and less access to care and treatment for mental health and health conditions.”

According to the report, increase in age reflected an increase in the prevalence of depression. The prevalence of major depression ranged from 2.8% among those aged 18-24 years to 4.6% among those aged 45-64. There was a decline to 1.6% among those older than 65.

In addition to age, factors such as socioeconomic status, amount of education, employment status, and access to health insurance played a significant role in the prevalence of depression. For example, 22.2% of people unable to work and 9.8% of those unemployed were more likely to report major depression, compared with 3% of homemakers and students, and 2% of employed individuals.

By state, North Dakota reported the lowest prevalence of current and major depression (4.18% and 1.5%, respectively) and Mississippi reported the highest prevalence for current depression (14.8%) and major depression (5.3%).

The CDC suggests that states take an active role in health care interventions to help the increasing number of people in need of treatment for their depression. “States that monitor the prevalence of current depression and major depression can analyze their data by participant characteristics, identify those populations at greatest risk, and target them for interventions,” the report said.

New data from the Centers for Disease and Control and Prevention reveal that nearly 1 in 10 U.S. adults met criteria for current depression. Women and nonwhites are at the greatest risk.

The CDC said in its Morbidity and Mortality Weekly Report, released Sept. 30, that by the year 2020, depression is expected to be second only to cardiovascular disease in disease burden. In 2004, depression was the third leading cause of disease burden worldwide and a leading cause of disability in high-income countries.

The CDC warned that depression can exacerbate chronic conditions such as arthritis, asthma, cardiovascular disease, cancer, diabetes, and obesity, all of which can contribute to increased work absenteeism, short-term disability, and decreased productivity.

Using Behavioral Risk Factor Surveillance System telephone survey data from 2006 and 2008 involving 235,067 adults aged 18 and older in 45 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, the CDC found that 9% met criteria for current depression, including 3.4% who met criteria for major depression (MMWR Morb. Mortal. Wkly. Rep. 2010;59:1229-35).

The criteria for current depression were based on the Patient Health Questionnaire 8. People were considered to have major depression if for “more than half the days” they met at least five of the eight criteria, including at least one of the following: “little interest or pleasure in doing things” or “feeling down, depressed, or hopeless.”

The report showed a significant difference in the prevalence of depression between men and women. Four percent of women reported major depression, compared with 2.7% of men. “The greater prevalence of depression among women is not fully understood, although potential contributors include different responses to stressful life events, genetic predisposition, and hormonal differences,” the report said.

Non-Hispanic blacks, Hispanics, and non-Hispanics of other races were all more likely to report major depression (4%, 4%, and 4.3%, respectively) than were non-Hispanic whites (3.1%). The researchers explained that this disparity is consistent with greater risk factors of mental illness in these populations stemming from “social and economic inequality, exposure to racism and discrimination, increased prevalence of some chronic diseases, and less access to care and treatment for mental health and health conditions.”

According to the report, increase in age reflected an increase in the prevalence of depression. The prevalence of major depression ranged from 2.8% among those aged 18-24 years to 4.6% among those aged 45-64. There was a decline to 1.6% among those older than 65.

In addition to age, factors such as socioeconomic status, amount of education, employment status, and access to health insurance played a significant role in the prevalence of depression. For example, 22.2% of people unable to work and 9.8% of those unemployed were more likely to report major depression, compared with 3% of homemakers and students, and 2% of employed individuals.

By state, North Dakota reported the lowest prevalence of current and major depression (4.18% and 1.5%, respectively) and Mississippi reported the highest prevalence for current depression (14.8%) and major depression (5.3%).

The CDC suggests that states take an active role in health care interventions to help the increasing number of people in need of treatment for their depression. “States that monitor the prevalence of current depression and major depression can analyze their data by participant characteristics, identify those populations at greatest risk, and target them for interventions,” the report said.

New data from the Centers for Disease and Control and Prevention reveal that nearly 1 in 10 U.S. adults met criteria for current depression. Women and nonwhites are at the greatest risk.

The CDC said in its Morbidity and Mortality Weekly Report, released Sept. 30, that by the year 2020, depression is expected to be second only to cardiovascular disease in disease burden. In 2004, depression was the third leading cause of disease burden worldwide and a leading cause of disability in high-income countries.

The CDC warned that depression can exacerbate chronic conditions such as arthritis, asthma, cardiovascular disease, cancer, diabetes, and obesity, all of which can contribute to increased work absenteeism, short-term disability, and decreased productivity.

Using Behavioral Risk Factor Surveillance System telephone survey data from 2006 and 2008 involving 235,067 adults aged 18 and older in 45 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, the CDC found that 9% met criteria for current depression, including 3.4% who met criteria for major depression (MMWR Morb. Mortal. Wkly. Rep. 2010;59:1229-35).

The criteria for current depression were based on the Patient Health Questionnaire 8. People were considered to have major depression if for “more than half the days” they met at least five of the eight criteria, including at least one of the following: “little interest or pleasure in doing things” or “feeling down, depressed, or hopeless.”

The report showed a significant difference in the prevalence of depression between men and women. Four percent of women reported major depression, compared with 2.7% of men. “The greater prevalence of depression among women is not fully understood, although potential contributors include different responses to stressful life events, genetic predisposition, and hormonal differences,” the report said.

Non-Hispanic blacks, Hispanics, and non-Hispanics of other races were all more likely to report major depression (4%, 4%, and 4.3%, respectively) than were non-Hispanic whites (3.1%). The researchers explained that this disparity is consistent with greater risk factors of mental illness in these populations stemming from “social and economic inequality, exposure to racism and discrimination, increased prevalence of some chronic diseases, and less access to care and treatment for mental health and health conditions.”

According to the report, increase in age reflected an increase in the prevalence of depression. The prevalence of major depression ranged from 2.8% among those aged 18-24 years to 4.6% among those aged 45-64. There was a decline to 1.6% among those older than 65.

In addition to age, factors such as socioeconomic status, amount of education, employment status, and access to health insurance played a significant role in the prevalence of depression. For example, 22.2% of people unable to work and 9.8% of those unemployed were more likely to report major depression, compared with 3% of homemakers and students, and 2% of employed individuals.

By state, North Dakota reported the lowest prevalence of current and major depression (4.18% and 1.5%, respectively) and Mississippi reported the highest prevalence for current depression (14.8%) and major depression (5.3%).

The CDC suggests that states take an active role in health care interventions to help the increasing number of people in need of treatment for their depression. “States that monitor the prevalence of current depression and major depression can analyze their data by participant characteristics, identify those populations at greatest risk, and target them for interventions,” the report said.

The multiple sclerosis drug fingolimod has become the first oral treatment approved in the United States to reduce the frequency of flare-ups and slow disability from relapsing forms of the disease.

The drug, to be marketed as Gilenya in 0.5 mg capsules, represents the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators that are able “to block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help with reducing the severity of MS,” the Food and Drug Administration said Sept. 22 in a written statement.

“Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies,” Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.

The FDA approval is good news especially for patients who are weary of treatments involving injections or those who have failed other treatments, Dr. Jonathan Carter, associate professor of neurology at the Mayo Clinic in Scottsdale, Ariz., said in an interview: “We now have an oral therapy option, which has been an unmet need for many years in terms of MS therapies. There are patients who are really intolerant of injections because of needlephobia, or they just can't do it. This offers a treatment option for that group of patients.”

The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS) to educate patients and healthcare providers about safe use and serious risks of fingolimod. Drug manufacturer Novartis will conduct postmarketing research on “selected safety-related outcomes and a voluntary pregnancy registry,” the company said.

Patients taking fingolimod may experience bradycardia or bradyarrhythmia, serious infections, macular edema, and breathing and liver problems. The FDA said the most frequent adverse reactions in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes, and cough.

According to Novartis, Gilenya’s approval was based on the “largest clinical trial program ever submitted to date to the FDA for a new MS drug and included combined data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity, in people with relapsing forms of MS.”

The company-sponsored clinical trial included data from more than 2,600 patients with more than a total of 4,500 patient-years of experience, Novartis said in its own written statement Sept. 22. The trial also showed “superior efficacy by reducing relapses by 52% at one year compared with interferon beta-1a IM, a commonly prescribed treatment,” Novartis said. Some patients are in their seventh year of treatment, the company noted.

In the United States, MS affects more than 400,000 people and more than 2 million worldwide according to the National Multiple Sclerosis Society.

Russia was the first country to approve Gilenya; the company announced the drug’s 2011 Russian launch earlier this month.

Novartis first submitted Gilenya to the European Medicines Agency (EMA) and to the FDA for review in December 2009. The EMA regulatory review and other filings worldwide are ongoing.

The drug’s prescribing information will be available on the Drugs@FDA Web site, the agency said.

The multiple sclerosis drug fingolimod has become the first oral treatment approved in the United States to reduce the frequency of flare-ups and slow disability from relapsing forms of the disease.

The drug, to be marketed as Gilenya in 0.5 mg capsules, represents the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators that are able “to block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help with reducing the severity of MS,” the Food and Drug Administration said Sept. 22 in a written statement.

“Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies,” Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.

The FDA approval is good news especially for patients who are weary of treatments involving injections or those who have failed other treatments, Dr. Jonathan Carter, associate professor of neurology at the Mayo Clinic in Scottsdale, Ariz., said in an interview: “We now have an oral therapy option, which has been an unmet need for many years in terms of MS therapies. There are patients who are really intolerant of injections because of needlephobia, or they just can't do it. This offers a treatment option for that group of patients.”

The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS) to educate patients and healthcare providers about safe use and serious risks of fingolimod. Drug manufacturer Novartis will conduct postmarketing research on “selected safety-related outcomes and a voluntary pregnancy registry,” the company said.

Patients taking fingolimod may experience bradycardia or bradyarrhythmia, serious infections, macular edema, and breathing and liver problems. The FDA said the most frequent adverse reactions in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes, and cough.

According to Novartis, Gilenya’s approval was based on the “largest clinical trial program ever submitted to date to the FDA for a new MS drug and included combined data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity, in people with relapsing forms of MS.”

The company-sponsored clinical trial included data from more than 2,600 patients with more than a total of 4,500 patient-years of experience, Novartis said in its own written statement Sept. 22. The trial also showed “superior efficacy by reducing relapses by 52% at one year compared with interferon beta-1a IM, a commonly prescribed treatment,” Novartis said. Some patients are in their seventh year of treatment, the company noted.

In the United States, MS affects more than 400,000 people and more than 2 million worldwide according to the National Multiple Sclerosis Society.

Russia was the first country to approve Gilenya; the company announced the drug’s 2011 Russian launch earlier this month.

Novartis first submitted Gilenya to the European Medicines Agency (EMA) and to the FDA for review in December 2009. The EMA regulatory review and other filings worldwide are ongoing.

The drug’s prescribing information will be available on the Drugs@FDA Web site, the agency said.

The multiple sclerosis drug fingolimod has become the first oral treatment approved in the United States to reduce the frequency of flare-ups and slow disability from relapsing forms of the disease.

The drug, to be marketed as Gilenya in 0.5 mg capsules, represents the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators that are able “to block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help with reducing the severity of MS,” the Food and Drug Administration said Sept. 22 in a written statement.

“Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies,” Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.

The FDA approval is good news especially for patients who are weary of treatments involving injections or those who have failed other treatments, Dr. Jonathan Carter, associate professor of neurology at the Mayo Clinic in Scottsdale, Ariz., said in an interview: “We now have an oral therapy option, which has been an unmet need for many years in terms of MS therapies. There are patients who are really intolerant of injections because of needlephobia, or they just can't do it. This offers a treatment option for that group of patients.”

The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS) to educate patients and healthcare providers about safe use and serious risks of fingolimod. Drug manufacturer Novartis will conduct postmarketing research on “selected safety-related outcomes and a voluntary pregnancy registry,” the company said.

Patients taking fingolimod may experience bradycardia or bradyarrhythmia, serious infections, macular edema, and breathing and liver problems. The FDA said the most frequent adverse reactions in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes, and cough.

According to Novartis, Gilenya’s approval was based on the “largest clinical trial program ever submitted to date to the FDA for a new MS drug and included combined data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity, in people with relapsing forms of MS.”

The company-sponsored clinical trial included data from more than 2,600 patients with more than a total of 4,500 patient-years of experience, Novartis said in its own written statement Sept. 22. The trial also showed “superior efficacy by reducing relapses by 52% at one year compared with interferon beta-1a IM, a commonly prescribed treatment,” Novartis said. Some patients are in their seventh year of treatment, the company noted.

In the United States, MS affects more than 400,000 people and more than 2 million worldwide according to the National Multiple Sclerosis Society.

Russia was the first country to approve Gilenya; the company announced the drug’s 2011 Russian launch earlier this month.

Novartis first submitted Gilenya to the European Medicines Agency (EMA) and to the FDA for review in December 2009. The EMA regulatory review and other filings worldwide are ongoing.

The drug’s prescribing information will be available on the Drugs@FDA Web site, the agency said.

Smokeless tobacco products are not safer alternatives to cigarette smoking, do not help smokers quit, and their long-term use can, in fact, increase the risk of fatal heart attack, fatal stroke and cancer, the American Heart Association warned in a scientific statement published online Sept. 13.

© Fippzor/Fotolia.com

The researchers, led by Mariann R. Piano, Ph.D., examined several international studies to compare smokeless tobacco use and its health risks. Metaanalysis data involving male, Swedish smokers from 1976-2002 showed a significant decrease in cigarette smoking that corresponded with an increase in use of smokeless tobacco products, the investigators wrote in the AHA journal, Circulation. Despite the decline in cigarette use, concern is warranted, Dr. Piano, professor of biobehavioral science at the University of Illinois at Chicago, explained: “Smokeless tobacco products are harmful and addictive – that does not translate to a better alternative,” Dr. Piano, said in a written statement released by the AHA.

“Scientists and policy makers need to assess the effect of ‘reduced risk’ messages related to smokeless tobacco use on public perception, especially among smokers who might be trying to quit,” Dr. Piano and her colleagues wrote. Citing “inadequate evidence of smoking cessation efficacy and safety,” the researchers deemed as inappropriate the promotion of smokeless tobacco as a way to reduce smoking-related diseases.

The American Heart Association does recommend nicotine replacement therapy (nicotine gum or a nicotine-releasing patch placed on the skin) as a safer option for cigarette smokers wanting to quit. “Clinical studies have found no increased risk of heart attack or stroke with either type of nicotine replacement therapy,” the AHA statement said in the written statement.

Metaanalysis data in the AHA scientific statement indicated that smokeless tobacco use was associated with an increased risk of heart disease (relative risk 1.12, n=8 studies) (Int J Epidemiol. 2007;36:789–804). Additionally, a subanalysis of INTERHEART (a study of 15,152 cases of first myocardial infarction in 52 countries) showed that tobacco chewers had a significantly increased risk of first myocardial infarction (odds ratio 2.23) compared with those who never used tobacco. Two other metaanalyses indicated that smokeless tobacco use was also associated with an increased risk of fatal stroke (RR 1.42, n=5 studies, and RR 1.40, n=5 studies).

The researchers explained that, like cigarettes, smokeless tobacco (ST) products still contain nicotine of varying concentrations as well as a number of carcinogens that are just as harmful. Cigarettes and oral snuff have similar amounts of nicotine (milligrams per gram of tobacco), while chewing tobacco appears to have “somewhat lower” amounts compared with cigarettes, Dr. Piano and her colleagues wrote. “Even though certain manufacturing techniques are used to reduce the level of these compounds in some products, they remain present in substantial concentrations in ST products, including Swedish snus,” they said.

In a comparison of nicotine concentration between three types of smokeless tobacco products (chewing tobacco, dry snuff, and moist snuff) and cigarettes sold in the United States, all of the smokeless tobacco products had nicotine concentrations that were similar to cigarettes with the highest concentrations (see chart).

Dr. Piano and her colleagues found that unlike the aforementioned Swedish cohorts, there was no reduction in smoking rates among people in the United States using smokeless tobacco. (The sale of smokeless tobacco products such as moist snuff or snus is banned in most of the European Union with the exception of Sweden and Norway.)

In the United States about 8.1 million people are users of smokeless tobacco and its use is more prevalent in men than women, and people between the ages of 18-25 are the most likely to use smokeless tobacco, the researchers wrote. According to the study, educational background and socioeconomic status coincided with who tends to use smokeless tobacco the most. High prevalence was reported among people with a high-school diploma as their highest level of education, as well as people who live in southern states and rural areas. Blue-collar workers and service or labor workers, as well as the unemployed, were among the regular users of smokeless tobacco products. Native Americans have the highest prevalence of use (9%) followed by whites (5.8%), African Americans (1.9%), Hispanics (0.8%), and Asian Americans (0.6%).

It also appears that while U.S. chewing tobacco use has been on the decline since the 1980s, snuff consumption and production is increasing, the researchers said.

Dr. Piano reported that she received a grant from the National Institutes of Health. The researchers reported no relevant conflicts of interest.

Nicotine Concentrations in Smokeless Tobacco Products and Cigarettes Sold in the United States

Smokeless Tobacco in the U.S.A.

In a scientific statement published in Circulation, the American Heart Association highlighted other trends related to smokeless tobacco (ST) use in the United States.

As smoke-free air laws become more commonplace in public areas, the AHA said, smokeless tobacco marketers have been promoting their products for use where cigarette smoking is prohibited. The researchers also pointed out a rise in smokeless tobacco use in teenage boys and reported that in 2008 1.4 million people aged 12 and older began using smokeless tobacco, up 47% from 2002 figures. In addition, and of concern, the researchers said, “less than half of the new initiates of ST product use were less than 18 years of age at first use and adolescent males.”

In response to these trends, the Food and Drug Administration issued a final regulation prohibiting the sale of tobacco products —smokeless and otherwise — to anyone under the age of 18. This regulation is a part of the Family Smoking Prevention and Tobacco Control Act. The act has specific requirements about the labeling of smokeless tobacco products and advertisements, which must include at least 1 of these 4 warnings:

WARNING: This product can cause mouth cancer.

WARNING: This product can cause gum disease and tooth loss.

WARNING: This product is not a safe alternative to cigarettes.

WARNING: Smokeless tobacco is addictive.

As of June 22, all tobacco products had to have these labels and follow the guidelines. Smokeless tobacco products had until July 22 to comply with the new laws regarding labeling.

Smokeless tobacco products are not safer alternatives to cigarette smoking, do not help smokers quit, and their long-term use can, in fact, increase the risk of fatal heart attack, fatal stroke and cancer, the American Heart Association warned in a scientific statement published online Sept. 13.

© Fippzor/Fotolia.com

The researchers, led by Mariann R. Piano, Ph.D., examined several international studies to compare smokeless tobacco use and its health risks. Metaanalysis data involving male, Swedish smokers from 1976-2002 showed a significant decrease in cigarette smoking that corresponded with an increase in use of smokeless tobacco products, the investigators wrote in the AHA journal, Circulation. Despite the decline in cigarette use, concern is warranted, Dr. Piano, professor of biobehavioral science at the University of Illinois at Chicago, explained: “Smokeless tobacco products are harmful and addictive – that does not translate to a better alternative,” Dr. Piano, said in a written statement released by the AHA.

“Scientists and policy makers need to assess the effect of ‘reduced risk’ messages related to smokeless tobacco use on public perception, especially among smokers who might be trying to quit,” Dr. Piano and her colleagues wrote. Citing “inadequate evidence of smoking cessation efficacy and safety,” the researchers deemed as inappropriate the promotion of smokeless tobacco as a way to reduce smoking-related diseases.

The American Heart Association does recommend nicotine replacement therapy (nicotine gum or a nicotine-releasing patch placed on the skin) as a safer option for cigarette smokers wanting to quit. “Clinical studies have found no increased risk of heart attack or stroke with either type of nicotine replacement therapy,” the AHA statement said in the written statement.

Metaanalysis data in the AHA scientific statement indicated that smokeless tobacco use was associated with an increased risk of heart disease (relative risk 1.12, n=8 studies) (Int J Epidemiol. 2007;36:789–804). Additionally, a subanalysis of INTERHEART (a study of 15,152 cases of first myocardial infarction in 52 countries) showed that tobacco chewers had a significantly increased risk of first myocardial infarction (odds ratio 2.23) compared with those who never used tobacco. Two other metaanalyses indicated that smokeless tobacco use was also associated with an increased risk of fatal stroke (RR 1.42, n=5 studies, and RR 1.40, n=5 studies).

The researchers explained that, like cigarettes, smokeless tobacco (ST) products still contain nicotine of varying concentrations as well as a number of carcinogens that are just as harmful. Cigarettes and oral snuff have similar amounts of nicotine (milligrams per gram of tobacco), while chewing tobacco appears to have “somewhat lower” amounts compared with cigarettes, Dr. Piano and her colleagues wrote. “Even though certain manufacturing techniques are used to reduce the level of these compounds in some products, they remain present in substantial concentrations in ST products, including Swedish snus,” they said.

In a comparison of nicotine concentration between three types of smokeless tobacco products (chewing tobacco, dry snuff, and moist snuff) and cigarettes sold in the United States, all of the smokeless tobacco products had nicotine concentrations that were similar to cigarettes with the highest concentrations (see chart).

Dr. Piano and her colleagues found that unlike the aforementioned Swedish cohorts, there was no reduction in smoking rates among people in the United States using smokeless tobacco. (The sale of smokeless tobacco products such as moist snuff or snus is banned in most of the European Union with the exception of Sweden and Norway.)

In the United States about 8.1 million people are users of smokeless tobacco and its use is more prevalent in men than women, and people between the ages of 18-25 are the most likely to use smokeless tobacco, the researchers wrote. According to the study, educational background and socioeconomic status coincided with who tends to use smokeless tobacco the most. High prevalence was reported among people with a high-school diploma as their highest level of education, as well as people who live in southern states and rural areas. Blue-collar workers and service or labor workers, as well as the unemployed, were among the regular users of smokeless tobacco products. Native Americans have the highest prevalence of use (9%) followed by whites (5.8%), African Americans (1.9%), Hispanics (0.8%), and Asian Americans (0.6%).

It also appears that while U.S. chewing tobacco use has been on the decline since the 1980s, snuff consumption and production is increasing, the researchers said.

Dr. Piano reported that she received a grant from the National Institutes of Health. The researchers reported no relevant conflicts of interest.

Nicotine Concentrations in Smokeless Tobacco Products and Cigarettes Sold in the United States

Smokeless Tobacco in the U.S.A.

In a scientific statement published in Circulation, the American Heart Association highlighted other trends related to smokeless tobacco (ST) use in the United States.

As smoke-free air laws become more commonplace in public areas, the AHA said, smokeless tobacco marketers have been promoting their products for use where cigarette smoking is prohibited. The researchers also pointed out a rise in smokeless tobacco use in teenage boys and reported that in 2008 1.4 million people aged 12 and older began using smokeless tobacco, up 47% from 2002 figures. In addition, and of concern, the researchers said, “less than half of the new initiates of ST product use were less than 18 years of age at first use and adolescent males.”

In response to these trends, the Food and Drug Administration issued a final regulation prohibiting the sale of tobacco products —smokeless and otherwise — to anyone under the age of 18. This regulation is a part of the Family Smoking Prevention and Tobacco Control Act. The act has specific requirements about the labeling of smokeless tobacco products and advertisements, which must include at least 1 of these 4 warnings:

WARNING: This product can cause mouth cancer.

WARNING: This product can cause gum disease and tooth loss.

WARNING: This product is not a safe alternative to cigarettes.

WARNING: Smokeless tobacco is addictive.

As of June 22, all tobacco products had to have these labels and follow the guidelines. Smokeless tobacco products had until July 22 to comply with the new laws regarding labeling.

Smokeless tobacco products are not safer alternatives to cigarette smoking, do not help smokers quit, and their long-term use can, in fact, increase the risk of fatal heart attack, fatal stroke and cancer, the American Heart Association warned in a scientific statement published online Sept. 13.

© Fippzor/Fotolia.com

The researchers, led by Mariann R. Piano, Ph.D., examined several international studies to compare smokeless tobacco use and its health risks. Metaanalysis data involving male, Swedish smokers from 1976-2002 showed a significant decrease in cigarette smoking that corresponded with an increase in use of smokeless tobacco products, the investigators wrote in the AHA journal, Circulation. Despite the decline in cigarette use, concern is warranted, Dr. Piano, professor of biobehavioral science at the University of Illinois at Chicago, explained: “Smokeless tobacco products are harmful and addictive – that does not translate to a better alternative,” Dr. Piano, said in a written statement released by the AHA.

“Scientists and policy makers need to assess the effect of ‘reduced risk’ messages related to smokeless tobacco use on public perception, especially among smokers who might be trying to quit,” Dr. Piano and her colleagues wrote. Citing “inadequate evidence of smoking cessation efficacy and safety,” the researchers deemed as inappropriate the promotion of smokeless tobacco as a way to reduce smoking-related diseases.

The American Heart Association does recommend nicotine replacement therapy (nicotine gum or a nicotine-releasing patch placed on the skin) as a safer option for cigarette smokers wanting to quit. “Clinical studies have found no increased risk of heart attack or stroke with either type of nicotine replacement therapy,” the AHA statement said in the written statement.

Metaanalysis data in the AHA scientific statement indicated that smokeless tobacco use was associated with an increased risk of heart disease (relative risk 1.12, n=8 studies) (Int J Epidemiol. 2007;36:789–804). Additionally, a subanalysis of INTERHEART (a study of 15,152 cases of first myocardial infarction in 52 countries) showed that tobacco chewers had a significantly increased risk of first myocardial infarction (odds ratio 2.23) compared with those who never used tobacco. Two other metaanalyses indicated that smokeless tobacco use was also associated with an increased risk of fatal stroke (RR 1.42, n=5 studies, and RR 1.40, n=5 studies).

The researchers explained that, like cigarettes, smokeless tobacco (ST) products still contain nicotine of varying concentrations as well as a number of carcinogens that are just as harmful. Cigarettes and oral snuff have similar amounts of nicotine (milligrams per gram of tobacco), while chewing tobacco appears to have “somewhat lower” amounts compared with cigarettes, Dr. Piano and her colleagues wrote. “Even though certain manufacturing techniques are used to reduce the level of these compounds in some products, they remain present in substantial concentrations in ST products, including Swedish snus,” they said.

In a comparison of nicotine concentration between three types of smokeless tobacco products (chewing tobacco, dry snuff, and moist snuff) and cigarettes sold in the United States, all of the smokeless tobacco products had nicotine concentrations that were similar to cigarettes with the highest concentrations (see chart).

Dr. Piano and her colleagues found that unlike the aforementioned Swedish cohorts, there was no reduction in smoking rates among people in the United States using smokeless tobacco. (The sale of smokeless tobacco products such as moist snuff or snus is banned in most of the European Union with the exception of Sweden and Norway.)

In the United States about 8.1 million people are users of smokeless tobacco and its use is more prevalent in men than women, and people between the ages of 18-25 are the most likely to use smokeless tobacco, the researchers wrote. According to the study, educational background and socioeconomic status coincided with who tends to use smokeless tobacco the most. High prevalence was reported among people with a high-school diploma as their highest level of education, as well as people who live in southern states and rural areas. Blue-collar workers and service or labor workers, as well as the unemployed, were among the regular users of smokeless tobacco products. Native Americans have the highest prevalence of use (9%) followed by whites (5.8%), African Americans (1.9%), Hispanics (0.8%), and Asian Americans (0.6%).

It also appears that while U.S. chewing tobacco use has been on the decline since the 1980s, snuff consumption and production is increasing, the researchers said.

Dr. Piano reported that she received a grant from the National Institutes of Health. The researchers reported no relevant conflicts of interest.

Nicotine Concentrations in Smokeless Tobacco Products and Cigarettes Sold in the United States

Smokeless Tobacco in the U.S.A.

In a scientific statement published in Circulation, the American Heart Association highlighted other trends related to smokeless tobacco (ST) use in the United States.

As smoke-free air laws become more commonplace in public areas, the AHA said, smokeless tobacco marketers have been promoting their products for use where cigarette smoking is prohibited. The researchers also pointed out a rise in smokeless tobacco use in teenage boys and reported that in 2008 1.4 million people aged 12 and older began using smokeless tobacco, up 47% from 2002 figures. In addition, and of concern, the researchers said, “less than half of the new initiates of ST product use were less than 18 years of age at first use and adolescent males.”

In response to these trends, the Food and Drug Administration issued a final regulation prohibiting the sale of tobacco products —smokeless and otherwise — to anyone under the age of 18. This regulation is a part of the Family Smoking Prevention and Tobacco Control Act. The act has specific requirements about the labeling of smokeless tobacco products and advertisements, which must include at least 1 of these 4 warnings:

WARNING: This product can cause mouth cancer.

WARNING: This product can cause gum disease and tooth loss.

WARNING: This product is not a safe alternative to cigarettes.

WARNING: Smokeless tobacco is addictive.

As of June 22, all tobacco products had to have these labels and follow the guidelines. Smokeless tobacco products had until July 22 to comply with the new laws regarding labeling.

Smokeless tobacco products are not safer alternatives to cigarette smoking, do not help smokers quit, and their long-term use can, in fact, increase the risk of fatal heart attack, fatal stroke and cancer, the American Heart Association warned in a scientific statement published online Sept. 13.

© Fippzor/Fotolia.com

The researchers, led by Mariann R. Piano, Ph.D., examined several international studies to compare smokeless tobacco use and its health risks. Metaanalysis data involving male, Swedish smokers from 1976-2002 showed a significant decrease in cigarette smoking that corresponded with an increase in use of smokeless tobacco products, the investigators wrote in the AHA journal, Circulation. Despite the decline in cigarette use, concern is warranted, Dr. Piano, professor of biobehavioral science at the University of Illinois at Chicago, explained: “Smokeless tobacco products are harmful and addictive – that does not translate to a better alternative,” Dr. Piano, said in a written statement released by the AHA.

“Scientists and policy makers need to assess the effect of ‘reduced risk’ messages related to smokeless tobacco use on public perception, especially among smokers who might be trying to quit,” Dr. Piano and her colleagues wrote. Citing “inadequate evidence of smoking cessation efficacy and safety,” the researchers deemed as inappropriate the promotion of smokeless tobacco as a way to reduce smoking-related diseases.

The American Heart Association does recommend nicotine replacement therapy (nicotine gum or a nicotine-releasing patch placed on the skin) as a safer option for cigarette smokers wanting to quit. “Clinical studies have found no increased risk of heart attack or stroke with either type of nicotine replacement therapy,” the AHA statement said in the written statement.

Metaanalysis data in the AHA scientific statement indicated that smokeless tobacco use was associated with an increased risk of heart disease (relative risk 1.12, n=8 studies) (Int J Epidemiol. 2007;36:789–804). Additionally, a subanalysis of INTERHEART (a study of 15,152 cases of first myocardial infarction in 52 countries) showed that tobacco chewers had a significantly increased risk of first myocardial infarction (odds ratio 2.23) compared with those who never used tobacco. Two other metaanalyses indicated that smokeless tobacco use was also associated with an increased risk of fatal stroke (RR 1.42, n=5 studies, and RR 1.40, n=5 studies).

The researchers explained that, like cigarettes, smokeless tobacco (ST) products still contain nicotine of varying concentrations as well as a number of carcinogens that are just as harmful. Cigarettes and oral snuff have similar amounts of nicotine (milligrams per gram of tobacco), while chewing tobacco appears to have “somewhat lower” amounts compared with cigarettes, Dr. Piano and her colleagues wrote. “Even though certain manufacturing techniques are used to reduce the level of these compounds in some products, they remain present in substantial concentrations in ST products, including Swedish snus,” they said.

In a comparison of nicotine concentration between three types of smokeless tobacco products (chewing tobacco, dry snuff, and moist snuff) and cigarettes sold in the United States, all of the smokeless tobacco products had nicotine concentrations that were similar to cigarettes with the highest concentrations (see chart).

Dr. Piano and her colleagues found that unlike the aforementioned Swedish cohorts, there was no reduction in smoking rates among people in the United States using smokeless tobacco. (The sale of smokeless tobacco products such as moist snuff or snus is banned in most of the European Union with the exception of Sweden and Norway.)

In the United States about 8.1 million people are users of smokeless tobacco and its use is more prevalent in men than women, and people between the ages of 18-25 are the most likely to use smokeless tobacco, the researchers wrote. According to the study, educational background and socioeconomic status coincided with who tends to use smokeless tobacco the most. High prevalence was reported among people with a high-school diploma as their highest level of education, as well as people who live in southern states and rural areas. Blue-collar workers and service or labor workers, as well as the unemployed, were among the regular users of smokeless tobacco products. Native Americans have the highest prevalence of use (9%) followed by whites (5.8%), African Americans (1.9%), Hispanics (0.8%), and Asian Americans (0.6%).

It also appears that while U.S. chewing tobacco use has been on the decline since the 1980s, snuff consumption and production is increasing, the researchers said.

Dr. Piano reported that she received a grant from the National Institutes of Health. The researchers reported no relevant conflicts of interest.

Nicotine Concentrations in Smokeless Tobacco Products and Cigarettes Sold in the United States

Smokeless Tobacco in the U.S.A.

In a scientific statement published in Circulation, the American Heart Association highlighted other trends related to smokeless tobacco (ST) use in the United States.

As smoke-free air laws become more commonplace in public areas, the AHA said, smokeless tobacco marketers have been promoting their products for use where cigarette smoking is prohibited. The researchers also pointed out a rise in smokeless tobacco use in teenage boys and reported that in 2008 1.4 million people aged 12 and older began using smokeless tobacco, up 47% from 2002 figures. In addition, and of concern, the researchers said, “less than half of the new initiates of ST product use were less than 18 years of age at first use and adolescent males.”

In response to these trends, the Food and Drug Administration issued a final regulation prohibiting the sale of tobacco products —smokeless and otherwise — to anyone under the age of 18. This regulation is a part of the Family Smoking Prevention and Tobacco Control Act. The act has specific requirements about the labeling of smokeless tobacco products and advertisements, which must include at least 1 of these 4 warnings:

WARNING: This product can cause mouth cancer.

WARNING: This product can cause gum disease and tooth loss.

WARNING: This product is not a safe alternative to cigarettes.

WARNING: Smokeless tobacco is addictive.

As of June 22, all tobacco products had to have these labels and follow the guidelines. Smokeless tobacco products had until July 22 to comply with the new laws regarding labeling.

Smokeless tobacco products are not safer alternatives to cigarette smoking, do not help smokers quit, and their long-term use can, in fact, increase the risk of fatal heart attack, fatal stroke and cancer, the American Heart Association warned in a scientific statement published online Sept. 13.

© Fippzor/Fotolia.com

The researchers, led by Mariann R. Piano, Ph.D., examined several international studies to compare smokeless tobacco use and its health risks. Metaanalysis data involving male, Swedish smokers from 1976-2002 showed a significant decrease in cigarette smoking that corresponded with an increase in use of smokeless tobacco products, the investigators wrote in the AHA journal, Circulation. Despite the decline in cigarette use, concern is warranted, Dr. Piano, professor of biobehavioral science at the University of Illinois at Chicago, explained: “Smokeless tobacco products are harmful and addictive – that does not translate to a better alternative,” Dr. Piano, said in a written statement released by the AHA.

“Scientists and policy makers need to assess the effect of ‘reduced risk’ messages related to smokeless tobacco use on public perception, especially among smokers who might be trying to quit,” Dr. Piano and her colleagues wrote. Citing “inadequate evidence of smoking cessation efficacy and safety,” the researchers deemed as inappropriate the promotion of smokeless tobacco as a way to reduce smoking-related diseases.

The American Heart Association does recommend nicotine replacement therapy (nicotine gum or a nicotine-releasing patch placed on the skin) as a safer option for cigarette smokers wanting to quit. “Clinical studies have found no increased risk of heart attack or stroke with either type of nicotine replacement therapy,” the AHA statement said in the written statement.

Metaanalysis data in the AHA scientific statement indicated that smokeless tobacco use was associated with an increased risk of heart disease (relative risk 1.12, n=8 studies) (Int J Epidemiol. 2007;36:789–804). Additionally, a subanalysis of INTERHEART (a study of 15,152 cases of first myocardial infarction in 52 countries) showed that tobacco chewers had a significantly increased risk of first myocardial infarction (odds ratio 2.23) compared with those who never used tobacco. Two other metaanalyses indicated that smokeless tobacco use was also associated with an increased risk of fatal stroke (RR 1.42, n=5 studies, and RR 1.40, n=5 studies).

The researchers explained that, like cigarettes, smokeless tobacco (ST) products still contain nicotine of varying concentrations as well as a number of carcinogens that are just as harmful. Cigarettes and oral snuff have similar amounts of nicotine (milligrams per gram of tobacco), while chewing tobacco appears to have “somewhat lower” amounts compared with cigarettes, Dr. Piano and her colleagues wrote. “Even though certain manufacturing techniques are used to reduce the level of these compounds in some products, they remain present in substantial concentrations in ST products, including Swedish snus,” they said.

In a comparison of nicotine concentration between three types of smokeless tobacco products (chewing tobacco, dry snuff, and moist snuff) and cigarettes sold in the United States, all of the smokeless tobacco products had nicotine concentrations that were similar to cigarettes with the highest concentrations (see chart).

Dr. Piano and her colleagues found that unlike the aforementioned Swedish cohorts, there was no reduction in smoking rates among people in the United States using smokeless tobacco. (The sale of smokeless tobacco products such as moist snuff or snus is banned in most of the European Union with the exception of Sweden and Norway.)

In the United States about 8.1 million people are users of smokeless tobacco and its use is more prevalent in men than women, and people between the ages of 18-25 are the most likely to use smokeless tobacco, the researchers wrote. According to the study, educational background and socioeconomic status coincided with who tends to use smokeless tobacco the most. High prevalence was reported among people with a high-school diploma as their highest level of education, as well as people who live in southern states and rural areas. Blue-collar workers and service or labor workers, as well as the unemployed, were among the regular users of smokeless tobacco products. Native Americans have the highest prevalence of use (9%) followed by whites (5.8%), African Americans (1.9%), Hispanics (0.8%), and Asian Americans (0.6%).

It also appears that while U.S. chewing tobacco use has been on the decline since the 1980s, snuff consumption and production is increasing, the researchers said.

Dr. Piano reported that she received a grant from the National Institutes of Health. The researchers reported no relevant conflicts of interest.

Nicotine Concentrations in Smokeless Tobacco Products and Cigarettes Sold in the United States

Smokeless Tobacco in the U.S.A.

In a scientific statement published in Circulation, the American Heart Association highlighted other trends related to smokeless tobacco (ST) use in the United States.

As smoke-free air laws become more commonplace in public areas, the AHA said, smokeless tobacco marketers have been promoting their products for use where cigarette smoking is prohibited. The researchers also pointed out a rise in smokeless tobacco use in teenage boys and reported that in 2008 1.4 million people aged 12 and older began using smokeless tobacco, up 47% from 2002 figures. In addition, and of concern, the researchers said, “less than half of the new initiates of ST product use were less than 18 years of age at first use and adolescent males.”

In response to these trends, the Food and Drug Administration issued a final regulation prohibiting the sale of tobacco products —smokeless and otherwise — to anyone under the age of 18. This regulation is a part of the Family Smoking Prevention and Tobacco Control Act. The act has specific requirements about the labeling of smokeless tobacco products and advertisements, which must include at least 1 of these 4 warnings:

WARNING: This product can cause mouth cancer.

WARNING: This product can cause gum disease and tooth loss.

WARNING: This product is not a safe alternative to cigarettes.

WARNING: Smokeless tobacco is addictive.

As of June 22, all tobacco products had to have these labels and follow the guidelines. Smokeless tobacco products had until July 22 to comply with the new laws regarding labeling.

Smokeless tobacco products are not safer alternatives to cigarette smoking, do not help smokers quit, and their long-term use can, in fact, increase the risk of fatal heart attack, fatal stroke and cancer, the American Heart Association warned in a scientific statement published online Sept. 13.

© Fippzor/Fotolia.com

The researchers, led by Mariann R. Piano, Ph.D., examined several international studies to compare smokeless tobacco use and its health risks. Metaanalysis data involving male, Swedish smokers from 1976-2002 showed a significant decrease in cigarette smoking that corresponded with an increase in use of smokeless tobacco products, the investigators wrote in the AHA journal, Circulation. Despite the decline in cigarette use, concern is warranted, Dr. Piano, professor of biobehavioral science at the University of Illinois at Chicago, explained: “Smokeless tobacco products are harmful and addictive – that does not translate to a better alternative,” Dr. Piano, said in a written statement released by the AHA.

“Scientists and policy makers need to assess the effect of ‘reduced risk’ messages related to smokeless tobacco use on public perception, especially among smokers who might be trying to quit,” Dr. Piano and her colleagues wrote. Citing “inadequate evidence of smoking cessation efficacy and safety,” the researchers deemed as inappropriate the promotion of smokeless tobacco as a way to reduce smoking-related diseases.

The American Heart Association does recommend nicotine replacement therapy (nicotine gum or a nicotine-releasing patch placed on the skin) as a safer option for cigarette smokers wanting to quit. “Clinical studies have found no increased risk of heart attack or stroke with either type of nicotine replacement therapy,” the AHA statement said in the written statement.

Metaanalysis data in the AHA scientific statement indicated that smokeless tobacco use was associated with an increased risk of heart disease (relative risk 1.12, n=8 studies) (Int J Epidemiol. 2007;36:789–804). Additionally, a subanalysis of INTERHEART (a study of 15,152 cases of first myocardial infarction in 52 countries) showed that tobacco chewers had a significantly increased risk of first myocardial infarction (odds ratio 2.23) compared with those who never used tobacco. Two other metaanalyses indicated that smokeless tobacco use was also associated with an increased risk of fatal stroke (RR 1.42, n=5 studies, and RR 1.40, n=5 studies).

The researchers explained that, like cigarettes, smokeless tobacco (ST) products still contain nicotine of varying concentrations as well as a number of carcinogens that are just as harmful. Cigarettes and oral snuff have similar amounts of nicotine (milligrams per gram of tobacco), while chewing tobacco appears to have “somewhat lower” amounts compared with cigarettes, Dr. Piano and her colleagues wrote. “Even though certain manufacturing techniques are used to reduce the level of these compounds in some products, they remain present in substantial concentrations in ST products, including Swedish snus,” they said.

In a comparison of nicotine concentration between three types of smokeless tobacco products (chewing tobacco, dry snuff, and moist snuff) and cigarettes sold in the United States, all of the smokeless tobacco products had nicotine concentrations that were similar to cigarettes with the highest concentrations (see chart).

Dr. Piano and her colleagues found that unlike the aforementioned Swedish cohorts, there was no reduction in smoking rates among people in the United States using smokeless tobacco. (The sale of smokeless tobacco products such as moist snuff or snus is banned in most of the European Union with the exception of Sweden and Norway.)

In the United States about 8.1 million people are users of smokeless tobacco and its use is more prevalent in men than women, and people between the ages of 18-25 are the most likely to use smokeless tobacco, the researchers wrote. According to the study, educational background and socioeconomic status coincided with who tends to use smokeless tobacco the most. High prevalence was reported among people with a high-school diploma as their highest level of education, as well as people who live in southern states and rural areas. Blue-collar workers and service or labor workers, as well as the unemployed, were among the regular users of smokeless tobacco products. Native Americans have the highest prevalence of use (9%) followed by whites (5.8%), African Americans (1.9%), Hispanics (0.8%), and Asian Americans (0.6%).

It also appears that while U.S. chewing tobacco use has been on the decline since the 1980s, snuff consumption and production is increasing, the researchers said.

Dr. Piano reported that she received a grant from the National Institutes of Health. The researchers reported no relevant conflicts of interest.

Nicotine Concentrations in Smokeless Tobacco Products and Cigarettes Sold in the United States

Smokeless Tobacco in the U.S.A.

In a scientific statement published in Circulation, the American Heart Association highlighted other trends related to smokeless tobacco (ST) use in the United States.

As smoke-free air laws become more commonplace in public areas, the AHA said, smokeless tobacco marketers have been promoting their products for use where cigarette smoking is prohibited. The researchers also pointed out a rise in smokeless tobacco use in teenage boys and reported that in 2008 1.4 million people aged 12 and older began using smokeless tobacco, up 47% from 2002 figures. In addition, and of concern, the researchers said, “less than half of the new initiates of ST product use were less than 18 years of age at first use and adolescent males.”

In response to these trends, the Food and Drug Administration issued a final regulation prohibiting the sale of tobacco products —smokeless and otherwise — to anyone under the age of 18. This regulation is a part of the Family Smoking Prevention and Tobacco Control Act. The act has specific requirements about the labeling of smokeless tobacco products and advertisements, which must include at least 1 of these 4 warnings:

WARNING: This product can cause mouth cancer.

WARNING: This product can cause gum disease and tooth loss.

WARNING: This product is not a safe alternative to cigarettes.

WARNING: Smokeless tobacco is addictive.

As of June 22, all tobacco products had to have these labels and follow the guidelines. Smokeless tobacco products had until July 22 to comply with the new laws regarding labeling.

The pentavalent rotavirus and monovalent rotavirus vaccines are contraindicated in infants with severe combined immunodeficiency, according to recommendations from the Centers for Disease Control and Prevention.

The agency advised the contraindication in response to reports of vaccine-acquired rotavirus infection developing in infants with severe combined immunodeficiency (SCID) who had received the rotavirus vaccines, according to a report.

Vaccine manufacturers Merck & Co. and GlaxoSmithKline Biologicals had already revised the package inserts for their respective rotavirus vaccine products—RV5 and RV1—with approval from the Food and Drug Administration. Merck revised the labeling for RV5 in December 2009, and GlaxoSmithKline revised its labeling for RV1 in February 2010.

The CDC decided to recommend the contraindication after consulting with the former Rotavirus Vaccine Work Group of the Advisory Committee on Immunization Practices (ACIP), and reviewing the available data.

According to the CDC, SCID “includes a group of rare, life-threatening disorders caused by at least 15 different single gene defects that result in profound deficiencies in T- and B-lymphocyte function,” and the estimated incidence among infants in the United States is approximately 40–100 cases each year. Usually SCID is diagnosed after an infant has acquired a severe or potentially life-threatening infection caused by one or more pathogens, the CDC said (MMWR 2010;59:687–8).

The median age at diagnosis of SCID is 4–7 months, which overlaps with the ages for rotavirus vaccination recommended by ACIP (ages 2, 4, and 6 months for RV5; ages 2 and 4 months for RV1).

Rotavirus vaccination was introduced in the United States in 2006. Since then, the CDC said that five cases of vaccine-acquired rotavirus infection occurred among infants with SCID (four in the United States, one in Australia) who were vaccinated with the RV5.

“Two additional U.S. cases of vaccine-acquired infection in RV5-vaccinated infants with SCID and one case of vaccine-acquired infection in an RV1-vaccinated infant with SCID from outside the United States were reported to the Vaccine Adverse Event Reporting System (VAERS),” according to the report.

All eight infants (four male, four female) were diagnosed with SCID at age 3–9 months and had received one to three doses of rotavirus vaccine before the diagnosis. All the infants had diarrhea, and most had additional infections (such as Pneumocystis jiroveci, rhinovirus, Salmonella, Escherichia coli, and Giardia) at the time of SCID diagnosis, the CDC said.

For infants with “known or suspected altered immunocompetence,” the CDC recommends consultation with an immunologist or infectious disease specialist “before rotavirus vaccine is administered.”

The pentavalent rotavirus and monovalent rotavirus vaccines are contraindicated in infants with severe combined immunodeficiency, according to recommendations from the Centers for Disease Control and Prevention.

The agency advised the contraindication in response to reports of vaccine-acquired rotavirus infection developing in infants with severe combined immunodeficiency (SCID) who had received the rotavirus vaccines, according to a report.

Vaccine manufacturers Merck & Co. and GlaxoSmithKline Biologicals had already revised the package inserts for their respective rotavirus vaccine products—RV5 and RV1—with approval from the Food and Drug Administration. Merck revised the labeling for RV5 in December 2009, and GlaxoSmithKline revised its labeling for RV1 in February 2010.

The CDC decided to recommend the contraindication after consulting with the former Rotavirus Vaccine Work Group of the Advisory Committee on Immunization Practices (ACIP), and reviewing the available data.

According to the CDC, SCID “includes a group of rare, life-threatening disorders caused by at least 15 different single gene defects that result in profound deficiencies in T- and B-lymphocyte function,” and the estimated incidence among infants in the United States is approximately 40–100 cases each year. Usually SCID is diagnosed after an infant has acquired a severe or potentially life-threatening infection caused by one or more pathogens, the CDC said (MMWR 2010;59:687–8).

The median age at diagnosis of SCID is 4–7 months, which overlaps with the ages for rotavirus vaccination recommended by ACIP (ages 2, 4, and 6 months for RV5; ages 2 and 4 months for RV1).

Rotavirus vaccination was introduced in the United States in 2006. Since then, the CDC said that five cases of vaccine-acquired rotavirus infection occurred among infants with SCID (four in the United States, one in Australia) who were vaccinated with the RV5.

“Two additional U.S. cases of vaccine-acquired infection in RV5-vaccinated infants with SCID and one case of vaccine-acquired infection in an RV1-vaccinated infant with SCID from outside the United States were reported to the Vaccine Adverse Event Reporting System (VAERS),” according to the report.

All eight infants (four male, four female) were diagnosed with SCID at age 3–9 months and had received one to three doses of rotavirus vaccine before the diagnosis. All the infants had diarrhea, and most had additional infections (such as Pneumocystis jiroveci, rhinovirus, Salmonella, Escherichia coli, and Giardia) at the time of SCID diagnosis, the CDC said.

For infants with “known or suspected altered immunocompetence,” the CDC recommends consultation with an immunologist or infectious disease specialist “before rotavirus vaccine is administered.”

The pentavalent rotavirus and monovalent rotavirus vaccines are contraindicated in infants with severe combined immunodeficiency, according to recommendations from the Centers for Disease Control and Prevention.

The agency advised the contraindication in response to reports of vaccine-acquired rotavirus infection developing in infants with severe combined immunodeficiency (SCID) who had received the rotavirus vaccines, according to a report.

Vaccine manufacturers Merck & Co. and GlaxoSmithKline Biologicals had already revised the package inserts for their respective rotavirus vaccine products—RV5 and RV1—with approval from the Food and Drug Administration. Merck revised the labeling for RV5 in December 2009, and GlaxoSmithKline revised its labeling for RV1 in February 2010.

The CDC decided to recommend the contraindication after consulting with the former Rotavirus Vaccine Work Group of the Advisory Committee on Immunization Practices (ACIP), and reviewing the available data.

According to the CDC, SCID “includes a group of rare, life-threatening disorders caused by at least 15 different single gene defects that result in profound deficiencies in T- and B-lymphocyte function,” and the estimated incidence among infants in the United States is approximately 40–100 cases each year. Usually SCID is diagnosed after an infant has acquired a severe or potentially life-threatening infection caused by one or more pathogens, the CDC said (MMWR 2010;59:687–8).

The median age at diagnosis of SCID is 4–7 months, which overlaps with the ages for rotavirus vaccination recommended by ACIP (ages 2, 4, and 6 months for RV5; ages 2 and 4 months for RV1).

Rotavirus vaccination was introduced in the United States in 2006. Since then, the CDC said that five cases of vaccine-acquired rotavirus infection occurred among infants with SCID (four in the United States, one in Australia) who were vaccinated with the RV5.

“Two additional U.S. cases of vaccine-acquired infection in RV5-vaccinated infants with SCID and one case of vaccine-acquired infection in an RV1-vaccinated infant with SCID from outside the United States were reported to the Vaccine Adverse Event Reporting System (VAERS),” according to the report.

All eight infants (four male, four female) were diagnosed with SCID at age 3–9 months and had received one to three doses of rotavirus vaccine before the diagnosis. All the infants had diarrhea, and most had additional infections (such as Pneumocystis jiroveci, rhinovirus, Salmonella, Escherichia coli, and Giardia) at the time of SCID diagnosis, the CDC said.

For infants with “known or suspected altered immunocompetence,” the CDC recommends consultation with an immunologist or infectious disease specialist “before rotavirus vaccine is administered.”

Echoing President Obama’s key message on health care reform, U.S. Department of Health and Human Services Secretary Kathleen Sebelius held a press briefing June 14 to emphasize again that if Americans like their current health care plan, the Affordable Care Act allows them to keep it.

“The notion that everyone is going to loose their coverage is simply not the case,” Ms. Sebelius said.

In addition, Ms. Sebelius and Department of Labor Secretary Hilda Solis explained that the grandfather clause allows employers with existing health insurance plans (as of March 23, 2010) to make routine changes and still keep their grandfather status. However, Ms. Sebelius warned, employers and insurers will lose that status if they make coverage changes that effectively reduce or cancel coverage, or if they raise premiums or co-pays significantly.

If an employer chooses to make substantial changes to the plan that shift costs to the employees, “The rules of the road are clear... They basically have lost the grandfather status, and it is regarded as a new plan,” Ms. Sebelius said.

In the event that an employer or insurer loses its status, consumers in those plans will gain additional new benefits including coverage of recommended preventive health services at no additional cost and guaranteed access to ob gyns and pediatricians.

Ms. Sebelius predicted that large companies are more likely than smaller ones to meet the grandfather clause requirements and will therefore see fewer changes.

There will be oversight tools in place to penalize companies that try to raise rates and reduce or deny coverage. Such tools should make it easy to single out companies that increase their rates in ways that impact consumers negatively. Some companies may try to mask increases or try to justify their price increases, but there will be “enhanced ability at the federal level to reject excessive premiums,” she said.

Publishing premium rates should allow for “more transparency” and will also help keep companies in line, she added.

As of Sept. 23, all plans – grandfathered or not – will be required to provide:

– No lifetime limits on coverage;

– No rescissions of coverage when people get sick and have previously made an unintentional mistake on their application; and

– Extension of parents’ coverage to young adults under age 26 years.

In addition, for those Americans who get their health insurance through employers (the majority), additional benefits will be offered, irrespective of whether their plan is grandfathered. Those benefits include:

– No coverage exclusions for children with pre-existing conditions; and

– No “restricted” annual limits (e.g., annual dollar-amount limits on coverage below standards to be set in future regulations).

By 2014, Americans should be able to take advantage of the “same [health insurance] choices as members of Congress,” Ms. Sebelius said.

The act will give employers “a wide berth of flexibility,” allowing them to adjust to medical inflation, but also encouraging them to come to the table to work with the government to help lower costs, she said.

Ms. Sebelius, who met with members of the AMA earlier in the day, admitted that the “right financial incentives” are not in place for doctors and their practices, but “we have to work together to accelerate the change... and look at underlying costs.”

Echoing President Obama’s key message on health care reform, U.S. Department of Health and Human Services Secretary Kathleen Sebelius held a press briefing June 14 to emphasize again that if Americans like their current health care plan, the Affordable Care Act allows them to keep it.

“The notion that everyone is going to loose their coverage is simply not the case,” Ms. Sebelius said.

In addition, Ms. Sebelius and Department of Labor Secretary Hilda Solis explained that the grandfather clause allows employers with existing health insurance plans (as of March 23, 2010) to make routine changes and still keep their grandfather status. However, Ms. Sebelius warned, employers and insurers will lose that status if they make coverage changes that effectively reduce or cancel coverage, or if they raise premiums or co-pays significantly.

If an employer chooses to make substantial changes to the plan that shift costs to the employees, “The rules of the road are clear... They basically have lost the grandfather status, and it is regarded as a new plan,” Ms. Sebelius said.

In the event that an employer or insurer loses its status, consumers in those plans will gain additional new benefits including coverage of recommended preventive health services at no additional cost and guaranteed access to ob gyns and pediatricians.

Ms. Sebelius predicted that large companies are more likely than smaller ones to meet the grandfather clause requirements and will therefore see fewer changes.

There will be oversight tools in place to penalize companies that try to raise rates and reduce or deny coverage. Such tools should make it easy to single out companies that increase their rates in ways that impact consumers negatively. Some companies may try to mask increases or try to justify their price increases, but there will be “enhanced ability at the federal level to reject excessive premiums,” she said.

Publishing premium rates should allow for “more transparency” and will also help keep companies in line, she added.

As of Sept. 23, all plans – grandfathered or not – will be required to provide:

– No lifetime limits on coverage;

– No rescissions of coverage when people get sick and have previously made an unintentional mistake on their application; and

– Extension of parents’ coverage to young adults under age 26 years.

In addition, for those Americans who get their health insurance through employers (the majority), additional benefits will be offered, irrespective of whether their plan is grandfathered. Those benefits include:

– No coverage exclusions for children with pre-existing conditions; and

– No “restricted” annual limits (e.g., annual dollar-amount limits on coverage below standards to be set in future regulations).

By 2014, Americans should be able to take advantage of the “same [health insurance] choices as members of Congress,” Ms. Sebelius said.

The act will give employers “a wide berth of flexibility,” allowing them to adjust to medical inflation, but also encouraging them to come to the table to work with the government to help lower costs, she said.

Ms. Sebelius, who met with members of the AMA earlier in the day, admitted that the “right financial incentives” are not in place for doctors and their practices, but “we have to work together to accelerate the change... and look at underlying costs.”

Echoing President Obama’s key message on health care reform, U.S. Department of Health and Human Services Secretary Kathleen Sebelius held a press briefing June 14 to emphasize again that if Americans like their current health care plan, the Affordable Care Act allows them to keep it.

“The notion that everyone is going to loose their coverage is simply not the case,” Ms. Sebelius said.

In addition, Ms. Sebelius and Department of Labor Secretary Hilda Solis explained that the grandfather clause allows employers with existing health insurance plans (as of March 23, 2010) to make routine changes and still keep their grandfather status. However, Ms. Sebelius warned, employers and insurers will lose that status if they make coverage changes that effectively reduce or cancel coverage, or if they raise premiums or co-pays significantly.

If an employer chooses to make substantial changes to the plan that shift costs to the employees, “The rules of the road are clear... They basically have lost the grandfather status, and it is regarded as a new plan,” Ms. Sebelius said.

In the event that an employer or insurer loses its status, consumers in those plans will gain additional new benefits including coverage of recommended preventive health services at no additional cost and guaranteed access to ob gyns and pediatricians.

Ms. Sebelius predicted that large companies are more likely than smaller ones to meet the grandfather clause requirements and will therefore see fewer changes.

There will be oversight tools in place to penalize companies that try to raise rates and reduce or deny coverage. Such tools should make it easy to single out companies that increase their rates in ways that impact consumers negatively. Some companies may try to mask increases or try to justify their price increases, but there will be “enhanced ability at the federal level to reject excessive premiums,” she said.

Publishing premium rates should allow for “more transparency” and will also help keep companies in line, she added.

As of Sept. 23, all plans – grandfathered or not – will be required to provide:

– No lifetime limits on coverage;

– No rescissions of coverage when people get sick and have previously made an unintentional mistake on their application; and

– Extension of parents’ coverage to young adults under age 26 years.

In addition, for those Americans who get their health insurance through employers (the majority), additional benefits will be offered, irrespective of whether their plan is grandfathered. Those benefits include:

– No coverage exclusions for children with pre-existing conditions; and

– No “restricted” annual limits (e.g., annual dollar-amount limits on coverage below standards to be set in future regulations).

By 2014, Americans should be able to take advantage of the “same [health insurance] choices as members of Congress,” Ms. Sebelius said.

The act will give employers “a wide berth of flexibility,” allowing them to adjust to medical inflation, but also encouraging them to come to the table to work with the government to help lower costs, she said.

Ms. Sebelius, who met with members of the AMA earlier in the day, admitted that the “right financial incentives” are not in place for doctors and their practices, but “we have to work together to accelerate the change... and look at underlying costs.”

The rate of infection from sexually transmitted diseases is not slowing down any time soon—particularly among adolescent girls and African Americans, according to a report from the Centers for Disease and Control.

In 2008, about 1.2 million cases of chlamydia and nearly 337,000 cases of gonorrhea were reported. The highest numbers of chlamydia and gonorrhea (409,531 cases) were reported in girls aged 15-19 years. Young women aged 20-24 years followed closely behind.

Untreated STDs are estimated to cause at least 24,000 women to become infertile each year in the United States, the CDC said.

“When you take into account the severe health consequences of STDs and the millions of Americans infected every year, it is clear that much more work needs to be done to prevent unintended long-term health issues,” said Dr. Kevin Fenton, director of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.

Racial minorities continue to be heavily affected by STDs, and African Americans continue to lead in number of the cases reported. According to the report, “gonorrhea rates among African Americans were higher than any other racial or ethnic group and 20 times higher than that of whites.” Although African Americans represent 12% of the U.S. population, “they accounted for about 71% of reported gonorrhea cases and almost half of all chlamydia and syphilis cases (48% and 49%, respectively) in 2008,” the CDC reported.

“We cannot ignore the glaring racial disparities in rates of STDs, particularly when we consider the hard truth that gonorrhea rates among African Americans are 20 times those of whites,” said Dr. John M. Douglas Jr., director of the CDC's Division of STD Prevention.

The report cited these statistics:

▸ Gonorrhea. In 2008, the gonorrhea rate among blacks was more than 20 times higher than that of whites (625 cases/100,000 vs. 31/100,000).

▸ Chlamydia. The chlamydia rate among blacks in 2008 was more than eight times higher than that of whites (1,519 cases/100,000 vs. 174).

▸ Syphilis. The 2008 syphilis rate among blacks was about eight times higher than that of whites (17 cases/100,000 vs. 2).

Hispanic and American Indian/Alaskan Natives also saw “significant” increases in STD cases, the report said. Rates of gonorrhea infections among Hispanics and American Indian/Alaskan Natives were more than two and three times higher, respectively, than in whites. Chlamydia rates in those populations were about three and five times higher. Syphilis infection rates among Hispanics were double those of whites; the rate among American Indian/Alaskan Natives was comparable with that of whites.

“Research has shown that socioeconomic barriers to quality health care and higher overall prevalence of STDs within minority communities contribute to this pervasive threat,” Dr. Douglas said.

“Chlamydia, gonorrhea, and syphilis cases represent only a fraction of the true STD burden in the United States,” the CDC said. Almost 19 million new sexually transmitted infections occur each year, almost half of which are among 15- to 24-year-olds. Annually, the CDC estimates that STDs cost the U.S. health care system as much as $15.9 billion.

The agency recommends annual chlamydia screening for sexually active women younger than 26 years and supports U.S. Preventive Services Task Force recommendations to screen high-risk, sexually active women for gonorrhea. The CDC also recommends that all sexually active men who have sex with men be tested at least annually for syphilis, chlamydia, gonorrhea, and HIV.

'We cannot ignore the glaring racial disparities in rates of STDs.'

Source DR. DOUGLAS

The rate of infection from sexually transmitted diseases is not slowing down any time soon—particularly among adolescent girls and African Americans, according to a report from the Centers for Disease and Control.

In 2008, about 1.2 million cases of chlamydia and nearly 337,000 cases of gonorrhea were reported. The highest numbers of chlamydia and gonorrhea (409,531 cases) were reported in girls aged 15-19 years. Young women aged 20-24 years followed closely behind.

Untreated STDs are estimated to cause at least 24,000 women to become infertile each year in the United States, the CDC said.

“When you take into account the severe health consequences of STDs and the millions of Americans infected every year, it is clear that much more work needs to be done to prevent unintended long-term health issues,” said Dr. Kevin Fenton, director of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.

Racial minorities continue to be heavily affected by STDs, and African Americans continue to lead in number of the cases reported. According to the report, “gonorrhea rates among African Americans were higher than any other racial or ethnic group and 20 times higher than that of whites.” Although African Americans represent 12% of the U.S. population, “they accounted for about 71% of reported gonorrhea cases and almost half of all chlamydia and syphilis cases (48% and 49%, respectively) in 2008,” the CDC reported.

“We cannot ignore the glaring racial disparities in rates of STDs, particularly when we consider the hard truth that gonorrhea rates among African Americans are 20 times those of whites,” said Dr. John M. Douglas Jr., director of the CDC's Division of STD Prevention.

The report cited these statistics:

▸ Gonorrhea. In 2008, the gonorrhea rate among blacks was more than 20 times higher than that of whites (625 cases/100,000 vs. 31/100,000).

▸ Chlamydia. The chlamydia rate among blacks in 2008 was more than eight times higher than that of whites (1,519 cases/100,000 vs. 174).

▸ Syphilis. The 2008 syphilis rate among blacks was about eight times higher than that of whites (17 cases/100,000 vs. 2).

Hispanic and American Indian/Alaskan Natives also saw “significant” increases in STD cases, the report said. Rates of gonorrhea infections among Hispanics and American Indian/Alaskan Natives were more than two and three times higher, respectively, than in whites. Chlamydia rates in those populations were about three and five times higher. Syphilis infection rates among Hispanics were double those of whites; the rate among American Indian/Alaskan Natives was comparable with that of whites.

“Research has shown that socioeconomic barriers to quality health care and higher overall prevalence of STDs within minority communities contribute to this pervasive threat,” Dr. Douglas said.

“Chlamydia, gonorrhea, and syphilis cases represent only a fraction of the true STD burden in the United States,” the CDC said. Almost 19 million new sexually transmitted infections occur each year, almost half of which are among 15- to 24-year-olds. Annually, the CDC estimates that STDs cost the U.S. health care system as much as $15.9 billion.

The agency recommends annual chlamydia screening for sexually active women younger than 26 years and supports U.S. Preventive Services Task Force recommendations to screen high-risk, sexually active women for gonorrhea. The CDC also recommends that all sexually active men who have sex with men be tested at least annually for syphilis, chlamydia, gonorrhea, and HIV.

'We cannot ignore the glaring racial disparities in rates of STDs.'

Source DR. DOUGLAS

The rate of infection from sexually transmitted diseases is not slowing down any time soon—particularly among adolescent girls and African Americans, according to a report from the Centers for Disease and Control.

In 2008, about 1.2 million cases of chlamydia and nearly 337,000 cases of gonorrhea were reported. The highest numbers of chlamydia and gonorrhea (409,531 cases) were reported in girls aged 15-19 years. Young women aged 20-24 years followed closely behind.

Untreated STDs are estimated to cause at least 24,000 women to become infertile each year in the United States, the CDC said.

“When you take into account the severe health consequences of STDs and the millions of Americans infected every year, it is clear that much more work needs to be done to prevent unintended long-term health issues,” said Dr. Kevin Fenton, director of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.

Racial minorities continue to be heavily affected by STDs, and African Americans continue to lead in number of the cases reported. According to the report, “gonorrhea rates among African Americans were higher than any other racial or ethnic group and 20 times higher than that of whites.” Although African Americans represent 12% of the U.S. population, “they accounted for about 71% of reported gonorrhea cases and almost half of all chlamydia and syphilis cases (48% and 49%, respectively) in 2008,” the CDC reported.

“We cannot ignore the glaring racial disparities in rates of STDs, particularly when we consider the hard truth that gonorrhea rates among African Americans are 20 times those of whites,” said Dr. John M. Douglas Jr., director of the CDC's Division of STD Prevention.

The report cited these statistics:

▸ Gonorrhea. In 2008, the gonorrhea rate among blacks was more than 20 times higher than that of whites (625 cases/100,000 vs. 31/100,000).

▸ Chlamydia. The chlamydia rate among blacks in 2008 was more than eight times higher than that of whites (1,519 cases/100,000 vs. 174).

▸ Syphilis. The 2008 syphilis rate among blacks was about eight times higher than that of whites (17 cases/100,000 vs. 2).

Hispanic and American Indian/Alaskan Natives also saw “significant” increases in STD cases, the report said. Rates of gonorrhea infections among Hispanics and American Indian/Alaskan Natives were more than two and three times higher, respectively, than in whites. Chlamydia rates in those populations were about three and five times higher. Syphilis infection rates among Hispanics were double those of whites; the rate among American Indian/Alaskan Natives was comparable with that of whites.

“Research has shown that socioeconomic barriers to quality health care and higher overall prevalence of STDs within minority communities contribute to this pervasive threat,” Dr. Douglas said.

“Chlamydia, gonorrhea, and syphilis cases represent only a fraction of the true STD burden in the United States,” the CDC said. Almost 19 million new sexually transmitted infections occur each year, almost half of which are among 15- to 24-year-olds. Annually, the CDC estimates that STDs cost the U.S. health care system as much as $15.9 billion.

The agency recommends annual chlamydia screening for sexually active women younger than 26 years and supports U.S. Preventive Services Task Force recommendations to screen high-risk, sexually active women for gonorrhea. The CDC also recommends that all sexually active men who have sex with men be tested at least annually for syphilis, chlamydia, gonorrhea, and HIV.

'We cannot ignore the glaring racial disparities in rates of STDs.'

Source DR. DOUGLAS

The Food and Drug Administration last month called on manufacturers of leukotriene inhibitors to include safety precautions on their drug's labeling, because of reports of neuropsychiatric events in patients taking these drugs.

The FDA said the reported neuropsychiatric events included cases of agitation, aggression, anxiety, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal ideation and behavior, and tremor in patients using montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo, Zyflo CR).

Manufacturers of these drugs were asked to submit all available clinical trial data for these products for the safety review that concluded in April.

In its review, the FDA found that some reports included clinical details consistent with a drug-induced effect.

According to an FDA update from May, most of the reports of neuropsychiatric events were associated with montelukast, which is the most commonly prescribed drug that acts through the leukotriene pathway.

In the clinical trial data submitted by the manufacturers, neuropsychiatric events were not commonly observed, the FDA said. “However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders [primarily insomnia] were reported more frequently with all three products compared to placebo.”

The FDA advises that patients and health care providers be aware of the potential for neuropsychiatric events with these drugs used to treat asthma and symptoms of allergic rhinitis. The agency also suggests that physicians discontinue treatment if patients develop neuropsychiatric symptoms.

More information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079523.htm

The Food and Drug Administration last month called on manufacturers of leukotriene inhibitors to include safety precautions on their drug's labeling, because of reports of neuropsychiatric events in patients taking these drugs.

The FDA said the reported neuropsychiatric events included cases of agitation, aggression, anxiety, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal ideation and behavior, and tremor in patients using montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo, Zyflo CR).

Manufacturers of these drugs were asked to submit all available clinical trial data for these products for the safety review that concluded in April.

In its review, the FDA found that some reports included clinical details consistent with a drug-induced effect.

According to an FDA update from May, most of the reports of neuropsychiatric events were associated with montelukast, which is the most commonly prescribed drug that acts through the leukotriene pathway.

In the clinical trial data submitted by the manufacturers, neuropsychiatric events were not commonly observed, the FDA said. “However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders [primarily insomnia] were reported more frequently with all three products compared to placebo.”

The FDA advises that patients and health care providers be aware of the potential for neuropsychiatric events with these drugs used to treat asthma and symptoms of allergic rhinitis. The agency also suggests that physicians discontinue treatment if patients develop neuropsychiatric symptoms.

More information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079523.htm

The Food and Drug Administration last month called on manufacturers of leukotriene inhibitors to include safety precautions on their drug's labeling, because of reports of neuropsychiatric events in patients taking these drugs.

The FDA said the reported neuropsychiatric events included cases of agitation, aggression, anxiety, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal ideation and behavior, and tremor in patients using montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo, Zyflo CR).

Manufacturers of these drugs were asked to submit all available clinical trial data for these products for the safety review that concluded in April.

In its review, the FDA found that some reports included clinical details consistent with a drug-induced effect.

According to an FDA update from May, most of the reports of neuropsychiatric events were associated with montelukast, which is the most commonly prescribed drug that acts through the leukotriene pathway.

In the clinical trial data submitted by the manufacturers, neuropsychiatric events were not commonly observed, the FDA said. “However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders [primarily insomnia] were reported more frequently with all three products compared to placebo.”

The FDA advises that patients and health care providers be aware of the potential for neuropsychiatric events with these drugs used to treat asthma and symptoms of allergic rhinitis. The agency also suggests that physicians discontinue treatment if patients develop neuropsychiatric symptoms.

More information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079523.htm

A review of data on cefepime indicates that the antibiotic is appropriate for its approved indications, despite earlier concerns that it may have been associated with an increase in mortality risk compared with other agents in its class, the U.S. Food and Drug Administration announced last month.

Cefepime, a cephalosporin antibiotic, is approved for the treatment of a variety of infections because of its extended spectrum of activity against Gram-positive and Gram-negative bacteria.

Cefepime's safety was determined based on the findings from trial-level and patient-level meta-analyses, “neither of which showed a statistically significant difference in mortality with cefepime,” the announcement said.

The FDA began reviewing safety data on cefepime (Maxipime) in November 2007, and compared mortality data with other beta-lactam antibacterials. A 38-trial meta-analysis published by Dr. Dafna Yahav and colleagues at the Rabin Medical Center in Israel, indicated a 1.26 risk ratio for 30-day all-cause mortality among patient taking cefepime compared with those taking other beta-lactam antibacterials.

In the FDA's follow-up investigation that involved additional data from the agent's manufacturer, Bristol-Meyers Squibb, data on 50 more trials were analyzed along with the initial 38 trials in Dr. Yahav's meta-analysis. All-cause 30-day post-therapy mortality rates were 6.2% for the 9,467 cefepime-treated patients and 6.0% for the 8,288 patient treated with comparison antibiotics, a difference that was not statistically significant.

According to the announcement, the FDA is continuing its investigation of cefepime and its potential mortality risk, using hospital drug utilization data. A separate investigation of this association has been requested of Bristol-Meyers Squibb. The results of these analyses are not expected for at least 1 year, according to the FDA.

A review of data on cefepime indicates that the antibiotic is appropriate for its approved indications, despite earlier concerns that it may have been associated with an increase in mortality risk compared with other agents in its class, the U.S. Food and Drug Administration announced last month.

Cefepime, a cephalosporin antibiotic, is approved for the treatment of a variety of infections because of its extended spectrum of activity against Gram-positive and Gram-negative bacteria.

Cefepime's safety was determined based on the findings from trial-level and patient-level meta-analyses, “neither of which showed a statistically significant difference in mortality with cefepime,” the announcement said.

The FDA began reviewing safety data on cefepime (Maxipime) in November 2007, and compared mortality data with other beta-lactam antibacterials. A 38-trial meta-analysis published by Dr. Dafna Yahav and colleagues at the Rabin Medical Center in Israel, indicated a 1.26 risk ratio for 30-day all-cause mortality among patient taking cefepime compared with those taking other beta-lactam antibacterials.

In the FDA's follow-up investigation that involved additional data from the agent's manufacturer, Bristol-Meyers Squibb, data on 50 more trials were analyzed along with the initial 38 trials in Dr. Yahav's meta-analysis. All-cause 30-day post-therapy mortality rates were 6.2% for the 9,467 cefepime-treated patients and 6.0% for the 8,288 patient treated with comparison antibiotics, a difference that was not statistically significant.

According to the announcement, the FDA is continuing its investigation of cefepime and its potential mortality risk, using hospital drug utilization data. A separate investigation of this association has been requested of Bristol-Meyers Squibb. The results of these analyses are not expected for at least 1 year, according to the FDA.

A review of data on cefepime indicates that the antibiotic is appropriate for its approved indications, despite earlier concerns that it may have been associated with an increase in mortality risk compared with other agents in its class, the U.S. Food and Drug Administration announced last month.

Cefepime, a cephalosporin antibiotic, is approved for the treatment of a variety of infections because of its extended spectrum of activity against Gram-positive and Gram-negative bacteria.

Cefepime's safety was determined based on the findings from trial-level and patient-level meta-analyses, “neither of which showed a statistically significant difference in mortality with cefepime,” the announcement said.

The FDA began reviewing safety data on cefepime (Maxipime) in November 2007, and compared mortality data with other beta-lactam antibacterials. A 38-trial meta-analysis published by Dr. Dafna Yahav and colleagues at the Rabin Medical Center in Israel, indicated a 1.26 risk ratio for 30-day all-cause mortality among patient taking cefepime compared with those taking other beta-lactam antibacterials.

In the FDA's follow-up investigation that involved additional data from the agent's manufacturer, Bristol-Meyers Squibb, data on 50 more trials were analyzed along with the initial 38 trials in Dr. Yahav's meta-analysis. All-cause 30-day post-therapy mortality rates were 6.2% for the 9,467 cefepime-treated patients and 6.0% for the 8,288 patient treated with comparison antibiotics, a difference that was not statistically significant.

According to the announcement, the FDA is continuing its investigation of cefepime and its potential mortality risk, using hospital drug utilization data. A separate investigation of this association has been requested of Bristol-Meyers Squibb. The results of these analyses are not expected for at least 1 year, according to the FDA.

WASHINGTON — The two researchers credited with discovering HIV in 1984, Dr. Robert C. Gallo and Dr. Luc A. Montagnier, came together in a “Global Call to Action” to remind the world on the 25th anniversary of their discovery that HIV/AIDS remains one of the largest global health threats.

Despite advances in treatment that allow people with the virus to live longer, “we are still facing an epidemic. There is no cure, no vaccine. The virus is spreading in developing countries,” Dr. Montagnier, president of the World Foundation for AIDS Research and Prevention, reminded the public at a media gathering. He stressed that education about HIV/AIDS prevention remains paramount—comparing the disease with the 2009-H1N1 flu that has dominated recent media coverage. “It is transmissible, not contagious like the 'swine flu,'” he said.

Dr. Gallo, director of the Institute of Human Virology at the University of Maryland, Baltimore, said the 25th anniversary “is a good time for a reminder. It's not to make criticisms but to make suggestions” about the enormity of the HIV/AIDS epidemic that continues to ravage the globe. The rate is particularly high not only in Africa but also in the United States, where blacks and Hispanics are infected in large numbers.

The groundbreaking researchers published articles in the May 4, 1984, edition of Science that led to the development of the HIV blood test, diagnostic use of which helped to control the pandemic.

Jeffrey S. Crowley, director of the White House Office of National AIDS Policy, said that the Obama Administration is working to lower rates of infection, to improve care for people living with the disease, and to find ways to address the health disparities in target populations.

“The president wants to continue America's commitment to the HIV/AIDS epidemic global leadership … but he also wants us to solve the domestic HIV/AIDS epidemic,” he added.

Mr. Crowley said Americans should not think that HIV/AIDS infection rates have slowed, considering the more than 56,000 new infections being reported in the United States each year.

Key goals of the “Global Call to Action” include:

▸ Greater investment in medical infrastructure and educational outreach programs in the most-affected U.S. communities.

▸ Development of HIV/AIDS treatment and control programs with institutions in developing countries. For example, programs that promote better nutrition, which contributes to a healthy immune system, can help reduce transmission rates and improve the quality of life for infected patients, Dr. Montagnier said.

▸ Cultivation of young scientists in the field of human virology. “We see less, particularly from the United States. Surely MD's are not going into research like they did when I was a young man,” Dr. Gallo said. More researchers in this field are coming from Eastern Europe, China, and India, he said.

▸ Enhancement of HIV/AIDS education and prevention, especially in highly affected countries.

▸ Commitment to the prevention of mother-to-child HIV transmission.

▸ Support for cutting-edge research for vaccines. Dr. Gallo said he believed that “a more major vaccine effort could have been initiated earlier,” but he noted that the National Institutes of Health, the Gates Foundation, and others currently are working very hard in vaccine development to make up for lost time.

Although some research out of the University of Pennsylvania, Philadelphia, has been promising, involving the removal of a special receptor with HIV cells and infusing stem cells back together, he noted that such ongoing research is “immensely expensive.”

Better therapies would be those that mitigate side effects and treatment resistance, he said, urging pharmaceutical companies to invest in vaccine research.

“We are not dead in AIDS research. There are still new discoveries to be made,” Dr. Montagnier said.

WASHINGTON — The two researchers credited with discovering HIV in 1984, Dr. Robert C. Gallo and Dr. Luc A. Montagnier, came together in a “Global Call to Action” to remind the world on the 25th anniversary of their discovery that HIV/AIDS remains one of the largest global health threats.

Despite advances in treatment that allow people with the virus to live longer, “we are still facing an epidemic. There is no cure, no vaccine. The virus is spreading in developing countries,” Dr. Montagnier, president of the World Foundation for AIDS Research and Prevention, reminded the public at a media gathering. He stressed that education about HIV/AIDS prevention remains paramount—comparing the disease with the 2009-H1N1 flu that has dominated recent media coverage. “It is transmissible, not contagious like the 'swine flu,'” he said.

Dr. Gallo, director of the Institute of Human Virology at the University of Maryland, Baltimore, said the 25th anniversary “is a good time for a reminder. It's not to make criticisms but to make suggestions” about the enormity of the HIV/AIDS epidemic that continues to ravage the globe. The rate is particularly high not only in Africa but also in the United States, where blacks and Hispanics are infected in large numbers.

The groundbreaking researchers published articles in the May 4, 1984, edition of Science that led to the development of the HIV blood test, diagnostic use of which helped to control the pandemic.

Jeffrey S. Crowley, director of the White House Office of National AIDS Policy, said that the Obama Administration is working to lower rates of infection, to improve care for people living with the disease, and to find ways to address the health disparities in target populations.

“The president wants to continue America's commitment to the HIV/AIDS epidemic global leadership … but he also wants us to solve the domestic HIV/AIDS epidemic,” he added.

Mr. Crowley said Americans should not think that HIV/AIDS infection rates have slowed, considering the more than 56,000 new infections being reported in the United States each year.

Key goals of the “Global Call to Action” include:

▸ Greater investment in medical infrastructure and educational outreach programs in the most-affected U.S. communities.

▸ Development of HIV/AIDS treatment and control programs with institutions in developing countries. For example, programs that promote better nutrition, which contributes to a healthy immune system, can help reduce transmission rates and improve the quality of life for infected patients, Dr. Montagnier said.

▸ Cultivation of young scientists in the field of human virology. “We see less, particularly from the United States. Surely MD's are not going into research like they did when I was a young man,” Dr. Gallo said. More researchers in this field are coming from Eastern Europe, China, and India, he said.

▸ Enhancement of HIV/AIDS education and prevention, especially in highly affected countries.

▸ Commitment to the prevention of mother-to-child HIV transmission.

▸ Support for cutting-edge research for vaccines. Dr. Gallo said he believed that “a more major vaccine effort could have been initiated earlier,” but he noted that the National Institutes of Health, the Gates Foundation, and others currently are working very hard in vaccine development to make up for lost time.

Although some research out of the University of Pennsylvania, Philadelphia, has been promising, involving the removal of a special receptor with HIV cells and infusing stem cells back together, he noted that such ongoing research is “immensely expensive.”

Better therapies would be those that mitigate side effects and treatment resistance, he said, urging pharmaceutical companies to invest in vaccine research.

“We are not dead in AIDS research. There are still new discoveries to be made,” Dr. Montagnier said.

WASHINGTON — The two researchers credited with discovering HIV in 1984, Dr. Robert C. Gallo and Dr. Luc A. Montagnier, came together in a “Global Call to Action” to remind the world on the 25th anniversary of their discovery that HIV/AIDS remains one of the largest global health threats.

Despite advances in treatment that allow people with the virus to live longer, “we are still facing an epidemic. There is no cure, no vaccine. The virus is spreading in developing countries,” Dr. Montagnier, president of the World Foundation for AIDS Research and Prevention, reminded the public at a media gathering. He stressed that education about HIV/AIDS prevention remains paramount—comparing the disease with the 2009-H1N1 flu that has dominated recent media coverage. “It is transmissible, not contagious like the 'swine flu,'” he said.

Dr. Gallo, director of the Institute of Human Virology at the University of Maryland, Baltimore, said the 25th anniversary “is a good time for a reminder. It's not to make criticisms but to make suggestions” about the enormity of the HIV/AIDS epidemic that continues to ravage the globe. The rate is particularly high not only in Africa but also in the United States, where blacks and Hispanics are infected in large numbers.

The groundbreaking researchers published articles in the May 4, 1984, edition of Science that led to the development of the HIV blood test, diagnostic use of which helped to control the pandemic.

Jeffrey S. Crowley, director of the White House Office of National AIDS Policy, said that the Obama Administration is working to lower rates of infection, to improve care for people living with the disease, and to find ways to address the health disparities in target populations.

“The president wants to continue America's commitment to the HIV/AIDS epidemic global leadership … but he also wants us to solve the domestic HIV/AIDS epidemic,” he added.

Mr. Crowley said Americans should not think that HIV/AIDS infection rates have slowed, considering the more than 56,000 new infections being reported in the United States each year.

Key goals of the “Global Call to Action” include:

▸ Greater investment in medical infrastructure and educational outreach programs in the most-affected U.S. communities.

▸ Development of HIV/AIDS treatment and control programs with institutions in developing countries. For example, programs that promote better nutrition, which contributes to a healthy immune system, can help reduce transmission rates and improve the quality of life for infected patients, Dr. Montagnier said.

▸ Cultivation of young scientists in the field of human virology. “We see less, particularly from the United States. Surely MD's are not going into research like they did when I was a young man,” Dr. Gallo said. More researchers in this field are coming from Eastern Europe, China, and India, he said.

▸ Enhancement of HIV/AIDS education and prevention, especially in highly affected countries.

▸ Commitment to the prevention of mother-to-child HIV transmission.

▸ Support for cutting-edge research for vaccines. Dr. Gallo said he believed that “a more major vaccine effort could have been initiated earlier,” but he noted that the National Institutes of Health, the Gates Foundation, and others currently are working very hard in vaccine development to make up for lost time.

Although some research out of the University of Pennsylvania, Philadelphia, has been promising, involving the removal of a special receptor with HIV cells and infusing stem cells back together, he noted that such ongoing research is “immensely expensive.”

Better therapies would be those that mitigate side effects and treatment resistance, he said, urging pharmaceutical companies to invest in vaccine research.

“We are not dead in AIDS research. There are still new discoveries to be made,” Dr. Montagnier said.