Deborah Reale

New research in the American Heart Association journal Hypertension indicates that almost 5% of pregnant women are prescribed antihypertensives, including some drugs that are contraindicated for mothers or their babies.

“Use of high blood pressure drugs during pregnancy is becoming increasingly common,” said Brian T. Bateman, MD, lead author and Assistant Professor of Anesthesia at Harvard Medical School in Boston, Massachusetts. "While we know high blood pressure, or hypertension, occurs in about 6% to 8% of all pregnancies, we know little about how women and their doctors treat the condition."¹

A database of more than 1 million Medicaid patients was studied. Of those patients, 48,453 (4.4%) filled prescriptions for high blood pressure drugs during their pregnancies.¹

Researchers found^1,2:

• Antihypertensive drug use increased from 3.5% to 4.9% between 2000 and 2006.
• Antihypertensive drug users were older than nonusers, more likely to have diabetes or kidney disease, and more likely to be white or black than Hispanic or Asian.
• Nearly 2% of pregnant women filled prescriptions for antihypertensive drugs during the first trimester; 1.7% during the second trimester; and 3.2% during the third trimester.
• Angiotensin-converting-enzyme (ACE) inhibitors and angiotensin receptor blockers—both of which have been shown to have harmful side effects during pregnancy—were used by 4.9% of users in the second trimester, and 1.1% in the third trimester.

Research is needed because there are limited data on the safety, efficacy, and proper use of antihypertensive drugs during pregnancy.

“These drugs can cause poor growth, kidney problems, and even death of the newborn, wrote Bateman. “If women are taking one of these blood pressure medications and they become pregnant or plan to do so, they and their doctors should discuss treatment choices during pregnancy.”¹

For access to the abstract, click here.

We want to hear from you! Tell us what you think.

New research in the American Heart Association journal Hypertension indicates that almost 5% of pregnant women are prescribed antihypertensives, including some drugs that are contraindicated for mothers or their babies.

“Use of high blood pressure drugs during pregnancy is becoming increasingly common,” said Brian T. Bateman, MD, lead author and Assistant Professor of Anesthesia at Harvard Medical School in Boston, Massachusetts. "While we know high blood pressure, or hypertension, occurs in about 6% to 8% of all pregnancies, we know little about how women and their doctors treat the condition."¹

A database of more than 1 million Medicaid patients was studied. Of those patients, 48,453 (4.4%) filled prescriptions for high blood pressure drugs during their pregnancies.¹

Researchers found^1,2:

• Antihypertensive drug use increased from 3.5% to 4.9% between 2000 and 2006.
• Antihypertensive drug users were older than nonusers, more likely to have diabetes or kidney disease, and more likely to be white or black than Hispanic or Asian.
• Nearly 2% of pregnant women filled prescriptions for antihypertensive drugs during the first trimester; 1.7% during the second trimester; and 3.2% during the third trimester.
• Angiotensin-converting-enzyme (ACE) inhibitors and angiotensin receptor blockers—both of which have been shown to have harmful side effects during pregnancy—were used by 4.9% of users in the second trimester, and 1.1% in the third trimester.

Research is needed because there are limited data on the safety, efficacy, and proper use of antihypertensive drugs during pregnancy.

“These drugs can cause poor growth, kidney problems, and even death of the newborn, wrote Bateman. “If women are taking one of these blood pressure medications and they become pregnant or plan to do so, they and their doctors should discuss treatment choices during pregnancy.”¹

For access to the abstract, click here.

We want to hear from you! Tell us what you think.

New research in the American Heart Association journal Hypertension indicates that almost 5% of pregnant women are prescribed antihypertensives, including some drugs that are contraindicated for mothers or their babies.

“Use of high blood pressure drugs during pregnancy is becoming increasingly common,” said Brian T. Bateman, MD, lead author and Assistant Professor of Anesthesia at Harvard Medical School in Boston, Massachusetts. "While we know high blood pressure, or hypertension, occurs in about 6% to 8% of all pregnancies, we know little about how women and their doctors treat the condition."¹

A database of more than 1 million Medicaid patients was studied. Of those patients, 48,453 (4.4%) filled prescriptions for high blood pressure drugs during their pregnancies.¹

Researchers found^1,2:

• Antihypertensive drug use increased from 3.5% to 4.9% between 2000 and 2006.
• Antihypertensive drug users were older than nonusers, more likely to have diabetes or kidney disease, and more likely to be white or black than Hispanic or Asian.
• Nearly 2% of pregnant women filled prescriptions for antihypertensive drugs during the first trimester; 1.7% during the second trimester; and 3.2% during the third trimester.
• Angiotensin-converting-enzyme (ACE) inhibitors and angiotensin receptor blockers—both of which have been shown to have harmful side effects during pregnancy—were used by 4.9% of users in the second trimester, and 1.1% in the third trimester.

Research is needed because there are limited data on the safety, efficacy, and proper use of antihypertensive drugs during pregnancy.

“These drugs can cause poor growth, kidney problems, and even death of the newborn, wrote Bateman. “If women are taking one of these blood pressure medications and they become pregnant or plan to do so, they and their doctors should discuss treatment choices during pregnancy.”¹

For access to the abstract, click here.

We want to hear from you! Tell us what you think.

Health and Human Services (HHS) Secretary Kathleen G. Sebelius recently announced that the date for compliance with International Classification of Diseases, 10th Edition, diagnosis and procedure codes, or ICD-10, has been changed from October 1, 2013, to October 1, 2014.

Secretary Sebelius noted that the date change has been made in reaction to many providers’ concerns about the administrative burdens they will face in years ahead due to implementation of electronic health records and the Affordable Care Act.¹

“ICD-10 codes provide more robust and specific data that will help improve patient care and enable the exchange of our health-care data with that of the rest of the world that has long been using ICD-10. Entities covered under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) will be required to use the ICD-10 diagnostic and procedure codes,” said Secretary Sebelius.”¹

The final rule was issued by the Centers for Medicare & Medicaid Services, and published in the Federal Register on September 5, 2012. The rule states that, “The change in the compliance date is intended to give covered health-care providers and other covered entities more time to prepare and fully test their systems to ensure a smooth and coordinated transition by all covered entities.”²

Adoption will “increase standardization within HIPAA standard transactions and provide a platform for other regulatory and industry initiatives. Their adoption will allow for a higher level of automation for health-care provider offices, particularly for provider processing of billing and insurance related tasks, eligibility responses from health plans, and remittance advice that describes health-care claim payments.”²

Decision based on costs versus savings

HHS is aware that health-care plans, hospitals, and physician practices are currently in the process of implementing the ICD-10 due to the anticipated 2013 compliance date. It is estimated that the 1-year delay may cost the entire health-care industry $1 billion to $6.6 billion. However, HHS also anticipates substantial savings ($3.6 billion to $8 billion) by avoiding costs that could incur if a significant number of providers are unprepared for the transition to ICD-10. Possible consequences of implementing ICD-10 in 2013 are: 1) health-care providers and plans could have to manually process claims for claims to be paid and 2) small health-care providers might have to arrange for loans or lines of credit to continue to provide health-care services because of delayed payments. The decision to delay administration of ICD-10 was based on these factors.³

The American Health Information Management Association (AHIMA) will continue to assist the industry through the implementation process. AHIMA CEO Lynne Thomas Gordon, MBA, RHIA, FACHE, CAE, wrote on August 24, 2012, “ICD-10-CM/PCS implementation is inevitable, but today’s news gives the health-care community the certainty and clarity it needs to move forward with implementation, testing, and training. We realize that a few are still apprehensive about the implementation process, and that is why AHIMA remains committed to assisting the health-care community with its transition to a new code set that will lead to improved patient care and reduced costs.”³

We want to hear from you! Tell us what you think.

Health and Human Services (HHS) Secretary Kathleen G. Sebelius recently announced that the date for compliance with International Classification of Diseases, 10th Edition, diagnosis and procedure codes, or ICD-10, has been changed from October 1, 2013, to October 1, 2014.

Secretary Sebelius noted that the date change has been made in reaction to many providers’ concerns about the administrative burdens they will face in years ahead due to implementation of electronic health records and the Affordable Care Act.¹

“ICD-10 codes provide more robust and specific data that will help improve patient care and enable the exchange of our health-care data with that of the rest of the world that has long been using ICD-10. Entities covered under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) will be required to use the ICD-10 diagnostic and procedure codes,” said Secretary Sebelius.”¹

The final rule was issued by the Centers for Medicare & Medicaid Services, and published in the Federal Register on September 5, 2012. The rule states that, “The change in the compliance date is intended to give covered health-care providers and other covered entities more time to prepare and fully test their systems to ensure a smooth and coordinated transition by all covered entities.”²

Adoption will “increase standardization within HIPAA standard transactions and provide a platform for other regulatory and industry initiatives. Their adoption will allow for a higher level of automation for health-care provider offices, particularly for provider processing of billing and insurance related tasks, eligibility responses from health plans, and remittance advice that describes health-care claim payments.”²

Decision based on costs versus savings

HHS is aware that health-care plans, hospitals, and physician practices are currently in the process of implementing the ICD-10 due to the anticipated 2013 compliance date. It is estimated that the 1-year delay may cost the entire health-care industry $1 billion to $6.6 billion. However, HHS also anticipates substantial savings ($3.6 billion to $8 billion) by avoiding costs that could incur if a significant number of providers are unprepared for the transition to ICD-10. Possible consequences of implementing ICD-10 in 2013 are: 1) health-care providers and plans could have to manually process claims for claims to be paid and 2) small health-care providers might have to arrange for loans or lines of credit to continue to provide health-care services because of delayed payments. The decision to delay administration of ICD-10 was based on these factors.³

The American Health Information Management Association (AHIMA) will continue to assist the industry through the implementation process. AHIMA CEO Lynne Thomas Gordon, MBA, RHIA, FACHE, CAE, wrote on August 24, 2012, “ICD-10-CM/PCS implementation is inevitable, but today’s news gives the health-care community the certainty and clarity it needs to move forward with implementation, testing, and training. We realize that a few are still apprehensive about the implementation process, and that is why AHIMA remains committed to assisting the health-care community with its transition to a new code set that will lead to improved patient care and reduced costs.”³

We want to hear from you! Tell us what you think.

Health and Human Services (HHS) Secretary Kathleen G. Sebelius recently announced that the date for compliance with International Classification of Diseases, 10th Edition, diagnosis and procedure codes, or ICD-10, has been changed from October 1, 2013, to October 1, 2014.

Secretary Sebelius noted that the date change has been made in reaction to many providers’ concerns about the administrative burdens they will face in years ahead due to implementation of electronic health records and the Affordable Care Act.¹

“ICD-10 codes provide more robust and specific data that will help improve patient care and enable the exchange of our health-care data with that of the rest of the world that has long been using ICD-10. Entities covered under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) will be required to use the ICD-10 diagnostic and procedure codes,” said Secretary Sebelius.”¹

The final rule was issued by the Centers for Medicare & Medicaid Services, and published in the Federal Register on September 5, 2012. The rule states that, “The change in the compliance date is intended to give covered health-care providers and other covered entities more time to prepare and fully test their systems to ensure a smooth and coordinated transition by all covered entities.”²

Adoption will “increase standardization within HIPAA standard transactions and provide a platform for other regulatory and industry initiatives. Their adoption will allow for a higher level of automation for health-care provider offices, particularly for provider processing of billing and insurance related tasks, eligibility responses from health plans, and remittance advice that describes health-care claim payments.”²

Decision based on costs versus savings

HHS is aware that health-care plans, hospitals, and physician practices are currently in the process of implementing the ICD-10 due to the anticipated 2013 compliance date. It is estimated that the 1-year delay may cost the entire health-care industry $1 billion to $6.6 billion. However, HHS also anticipates substantial savings ($3.6 billion to $8 billion) by avoiding costs that could incur if a significant number of providers are unprepared for the transition to ICD-10. Possible consequences of implementing ICD-10 in 2013 are: 1) health-care providers and plans could have to manually process claims for claims to be paid and 2) small health-care providers might have to arrange for loans or lines of credit to continue to provide health-care services because of delayed payments. The decision to delay administration of ICD-10 was based on these factors.³

The American Health Information Management Association (AHIMA) will continue to assist the industry through the implementation process. AHIMA CEO Lynne Thomas Gordon, MBA, RHIA, FACHE, CAE, wrote on August 24, 2012, “ICD-10-CM/PCS implementation is inevitable, but today’s news gives the health-care community the certainty and clarity it needs to move forward with implementation, testing, and training. We realize that a few are still apprehensive about the implementation process, and that is why AHIMA remains committed to assisting the health-care community with its transition to a new code set that will lead to improved patient care and reduced costs.”³

We want to hear from you! Tell us what you think.

Gonorrhea, the second most commonly reported infectious disease in the United States, is increasing in incidence because Neisseria gonorrhoeae is progressively developing antibiotic resistance. Results of laboratory studies have provoked growing concern that cephalosporins, the only class of antibiotics that meets the current Centers for Disease Control and Prevention (CDC) efficacy standards, are also becoming ineffective in the treatment of gonorrhea.¹

CDC updated its guidelines, as reported in Morbidity and Mortality Weekly Report (MMWR), recommending combination therapy with ceftriaxone and either azithromycin or doxycycline for uncomplicated gonorrhea. By revising the current treatment recommendations, the CDC hopes to delay cephalosporin resistance until new treatment options are developed.¹

Gonorrhea is a major cause of pelvic inflammatory disease, which can lead to tubal infertility, ectopic pregnancy, and chronic pelvic pain. A pregnant woman with untreated gonorrhea has a higher risk for miscarriage, preterm birth, or premature rupture of membranes. An infected mother can transmit the disease to her child, with risk of blindness, joint infection, and sepsis in the baby.² There is also strong epidemiologic and biologic evidence that N. gonorrhoeae infections enable HIV infection transmission.^1,3

INCREASING INFECTION RATES

After a decline in reported gonorrhea rates to 98.1 cases per 100,000 population in 2009, the rate increased slightly in 2010 to 100.8 per 100,000, with 309,341 cases reported in the United States. In 2010, the reported gonorrhea rate for women was 106.5 per 100,000, slightly higher than for men (94.1 per 100,000). Reported gonorrhea rates were highest among adolescent girls ages 15 to19 years (570.9 per 100,000) and young women ages 20 to 24 years (560.7 per 100,000). The largest increases were observed among men and woman ages 20 to 24 years (4.9%) and 30 to 34 years (3.2%).³

“In the United States, about 300,000 cases of gonorrhea are reported each year, but because infected people often have no symptoms, the actual number of cases is probably closer to 700,000,” reported Gail Bolan, director of the CDC’s Sexually Transmitted Disease Prevention Division.⁴

GROWING CONCERN OVER RESISTANCE

Signs of growing resistance have only been seen in laboratory studies; there are no reported cases of treatment-resistant gonorrhea in the Unites States. However, the evidence of emerging cephalosporin resistance is following a similar pattern to that seen in 2007, when gonorrhea became fluoroquinolone-resistant.^1,5

“The challenge is that there is not a well-studied second antibiotic we can turn to even when cephalosporin resistance does emerge,” said Robert D. Kirkcaldy, a medical epidemiologist at the CDC. “What we’ve been noticing is really since 2009 and 2010, it’s taking higher concentrations of antibiotic to kill the bacteria. This could mean resistance to the last antibiotic we have for gonorrhea could be on the horizon.”⁵

NEW CDC TREATMENT RECOMMENDATIONS

The CDC’s updated guidelines include treatment plans for uncomplicated disease; specific alternatives if ceftriaxone cannot be used; test-of-cure procedures; treatment failure strategies; and recommendations for sexual partners.¹

Uncomplicated disease

To treat uncomplicated urogenital, anorectal, and pharyngeal gonorrhea, the CDC now recommends combination therapy with a single intramuscular dose of ceftriaxone 250 mg plus either a single dose of azithromycin 1 g orally or doxycycline 100 mg orally twice a day for 7 days.

Ceftriaxone, as a single 250-mg intramuscular injection, provides high and sustained bactericidal blood levels and is highly efficacious at all anatomic sites of N. gonorrhoeae infection currently circulating in the US. Clinical data are not available that support the use of an increased dose.

The percentage of isolates exhibiting tetracycline resistance was high but remained stable from 2006 (20.6%) to 2011 (21.6%).

Alternatives

When ceftriaxone cannot be used to treat urogenital or rectal gonorrhea, there are two options:

• if ceftriaxone is not readily available, give cefixime 400 mg orally plus either azithromycin 1 g orally or doxycycline 100 mg twice daily orally for 7 days
• if ceftriaxone cannot be given because of severe allergy, give azithromycin 2 g orally in a single dose.

A patient with gonorrhea treated with an alternative regimen should return 1 week after treatment for a test-of-cure at the infected anatomic site.

Test-of-cure—specimen culture is essential

The ideal test-of-cure is performed with culture or, if culture is not readily available, with a nucleic acid amplification testing (NAAT). If the NAAT is positive, make every effort to perform a confirmatory culture. All positive cultures for test-of-cure should undergo phenotypic antimicrobial susceptibility testing.

Unfortunately, the capacity of US laboratories to isolate N. gonorrhoeae by culture is declining rapidly because of the widespread use of NAATs for diagnosing gonorrhea. CDC reporters del Rio and colleagues write in MMWR:¹

• It is essential that culture capacity for N. gonorrhoeae be maintained to monitor antimicrobial resistance trends and determine susceptibility to guide treatment following treatment failure. To help control gonorrhea in the United States, health-care providers must maintain the ability to collect specimens for culture and be knowledgeable of laboratories to which they can send specimens for culture. Health-care systems and health departments must support access to culture, and laboratories must maintain culture capacity or develop partnerships with laboratories that can perform culture.

Treatment failure

Clinicians treating a patient with persistent infection after treatment with the recommended therapy should culture relevant clinical specimens and perform antimicrobial susceptibility testing of N. gonorrhoeae isolates. Phenotypic antimicrobial susceptibility testing should be performed using disk diffusion, Etest (BioMerieux), or agar dilution. Data are limited on the use of NAAT-based antimicrobial susceptibility testing for genetic mutations.

Patients who experience treatment failure after treatment with alternative regimens should be treated with ceftriaxone 250 mg as a single intramuscular dose and azithromycin 2 g orally as a single dose and should receive infectious disease consultation.

Consult an infectious disease specialist, an STD/HIV Prevention Training Center, or the CDC for treatment advice, and report the case to the CDC through a health department within 24 hours of diagnosis. Conduct test-of-cure 7 days after re-treatment.

Sexual partners

Clinicians should make every effort to ensure that the patient’s sex partners from the preceding 60 days are evaluated promptly and treated as indicated.

“Treatment of patients with gonorrhea with the most effective therapy will limit the transmission of the disease, prevent complications, and slow the emergence of resistance,” wrote CDC reporters. “However, resistance to cephalosporins, including ceftriaxone, is expected to emerge. Reinvestment in gonorrhea prevention and control is warranted. New treatment options for gonorrhea are urgently needed.”¹

For the full MMWR article on new gonorrhea treatment guidelines, visit http://1.usa.gov/OxjuaQ

We want to hear from you! Tell us what you think.

Gonorrhea, the second most commonly reported infectious disease in the United States, is increasing in incidence because Neisseria gonorrhoeae is progressively developing antibiotic resistance. Results of laboratory studies have provoked growing concern that cephalosporins, the only class of antibiotics that meets the current Centers for Disease Control and Prevention (CDC) efficacy standards, are also becoming ineffective in the treatment of gonorrhea.¹

CDC updated its guidelines, as reported in Morbidity and Mortality Weekly Report (MMWR), recommending combination therapy with ceftriaxone and either azithromycin or doxycycline for uncomplicated gonorrhea. By revising the current treatment recommendations, the CDC hopes to delay cephalosporin resistance until new treatment options are developed.¹

Gonorrhea is a major cause of pelvic inflammatory disease, which can lead to tubal infertility, ectopic pregnancy, and chronic pelvic pain. A pregnant woman with untreated gonorrhea has a higher risk for miscarriage, preterm birth, or premature rupture of membranes. An infected mother can transmit the disease to her child, with risk of blindness, joint infection, and sepsis in the baby.² There is also strong epidemiologic and biologic evidence that N. gonorrhoeae infections enable HIV infection transmission.^1,3

INCREASING INFECTION RATES

After a decline in reported gonorrhea rates to 98.1 cases per 100,000 population in 2009, the rate increased slightly in 2010 to 100.8 per 100,000, with 309,341 cases reported in the United States. In 2010, the reported gonorrhea rate for women was 106.5 per 100,000, slightly higher than for men (94.1 per 100,000). Reported gonorrhea rates were highest among adolescent girls ages 15 to19 years (570.9 per 100,000) and young women ages 20 to 24 years (560.7 per 100,000). The largest increases were observed among men and woman ages 20 to 24 years (4.9%) and 30 to 34 years (3.2%).³

“In the United States, about 300,000 cases of gonorrhea are reported each year, but because infected people often have no symptoms, the actual number of cases is probably closer to 700,000,” reported Gail Bolan, director of the CDC’s Sexually Transmitted Disease Prevention Division.⁴

GROWING CONCERN OVER RESISTANCE

Signs of growing resistance have only been seen in laboratory studies; there are no reported cases of treatment-resistant gonorrhea in the Unites States. However, the evidence of emerging cephalosporin resistance is following a similar pattern to that seen in 2007, when gonorrhea became fluoroquinolone-resistant.^1,5

“The challenge is that there is not a well-studied second antibiotic we can turn to even when cephalosporin resistance does emerge,” said Robert D. Kirkcaldy, a medical epidemiologist at the CDC. “What we’ve been noticing is really since 2009 and 2010, it’s taking higher concentrations of antibiotic to kill the bacteria. This could mean resistance to the last antibiotic we have for gonorrhea could be on the horizon.”⁵

NEW CDC TREATMENT RECOMMENDATIONS

The CDC’s updated guidelines include treatment plans for uncomplicated disease; specific alternatives if ceftriaxone cannot be used; test-of-cure procedures; treatment failure strategies; and recommendations for sexual partners.¹

Uncomplicated disease

To treat uncomplicated urogenital, anorectal, and pharyngeal gonorrhea, the CDC now recommends combination therapy with a single intramuscular dose of ceftriaxone 250 mg plus either a single dose of azithromycin 1 g orally or doxycycline 100 mg orally twice a day for 7 days.

Ceftriaxone, as a single 250-mg intramuscular injection, provides high and sustained bactericidal blood levels and is highly efficacious at all anatomic sites of N. gonorrhoeae infection currently circulating in the US. Clinical data are not available that support the use of an increased dose.

The percentage of isolates exhibiting tetracycline resistance was high but remained stable from 2006 (20.6%) to 2011 (21.6%).

Alternatives

When ceftriaxone cannot be used to treat urogenital or rectal gonorrhea, there are two options:

• if ceftriaxone is not readily available, give cefixime 400 mg orally plus either azithromycin 1 g orally or doxycycline 100 mg twice daily orally for 7 days
• if ceftriaxone cannot be given because of severe allergy, give azithromycin 2 g orally in a single dose.

A patient with gonorrhea treated with an alternative regimen should return 1 week after treatment for a test-of-cure at the infected anatomic site.

Test-of-cure—specimen culture is essential

The ideal test-of-cure is performed with culture or, if culture is not readily available, with a nucleic acid amplification testing (NAAT). If the NAAT is positive, make every effort to perform a confirmatory culture. All positive cultures for test-of-cure should undergo phenotypic antimicrobial susceptibility testing.

Unfortunately, the capacity of US laboratories to isolate N. gonorrhoeae by culture is declining rapidly because of the widespread use of NAATs for diagnosing gonorrhea. CDC reporters del Rio and colleagues write in MMWR:¹

• It is essential that culture capacity for N. gonorrhoeae be maintained to monitor antimicrobial resistance trends and determine susceptibility to guide treatment following treatment failure. To help control gonorrhea in the United States, health-care providers must maintain the ability to collect specimens for culture and be knowledgeable of laboratories to which they can send specimens for culture. Health-care systems and health departments must support access to culture, and laboratories must maintain culture capacity or develop partnerships with laboratories that can perform culture.

Treatment failure

Clinicians treating a patient with persistent infection after treatment with the recommended therapy should culture relevant clinical specimens and perform antimicrobial susceptibility testing of N. gonorrhoeae isolates. Phenotypic antimicrobial susceptibility testing should be performed using disk diffusion, Etest (BioMerieux), or agar dilution. Data are limited on the use of NAAT-based antimicrobial susceptibility testing for genetic mutations.

Patients who experience treatment failure after treatment with alternative regimens should be treated with ceftriaxone 250 mg as a single intramuscular dose and azithromycin 2 g orally as a single dose and should receive infectious disease consultation.

Consult an infectious disease specialist, an STD/HIV Prevention Training Center, or the CDC for treatment advice, and report the case to the CDC through a health department within 24 hours of diagnosis. Conduct test-of-cure 7 days after re-treatment.

Sexual partners

Clinicians should make every effort to ensure that the patient’s sex partners from the preceding 60 days are evaluated promptly and treated as indicated.

“Treatment of patients with gonorrhea with the most effective therapy will limit the transmission of the disease, prevent complications, and slow the emergence of resistance,” wrote CDC reporters. “However, resistance to cephalosporins, including ceftriaxone, is expected to emerge. Reinvestment in gonorrhea prevention and control is warranted. New treatment options for gonorrhea are urgently needed.”¹

For the full MMWR article on new gonorrhea treatment guidelines, visit http://1.usa.gov/OxjuaQ

We want to hear from you! Tell us what you think.

Gonorrhea, the second most commonly reported infectious disease in the United States, is increasing in incidence because Neisseria gonorrhoeae is progressively developing antibiotic resistance. Results of laboratory studies have provoked growing concern that cephalosporins, the only class of antibiotics that meets the current Centers for Disease Control and Prevention (CDC) efficacy standards, are also becoming ineffective in the treatment of gonorrhea.¹

CDC updated its guidelines, as reported in Morbidity and Mortality Weekly Report (MMWR), recommending combination therapy with ceftriaxone and either azithromycin or doxycycline for uncomplicated gonorrhea. By revising the current treatment recommendations, the CDC hopes to delay cephalosporin resistance until new treatment options are developed.¹

Gonorrhea is a major cause of pelvic inflammatory disease, which can lead to tubal infertility, ectopic pregnancy, and chronic pelvic pain. A pregnant woman with untreated gonorrhea has a higher risk for miscarriage, preterm birth, or premature rupture of membranes. An infected mother can transmit the disease to her child, with risk of blindness, joint infection, and sepsis in the baby.² There is also strong epidemiologic and biologic evidence that N. gonorrhoeae infections enable HIV infection transmission.^1,3

INCREASING INFECTION RATES

After a decline in reported gonorrhea rates to 98.1 cases per 100,000 population in 2009, the rate increased slightly in 2010 to 100.8 per 100,000, with 309,341 cases reported in the United States. In 2010, the reported gonorrhea rate for women was 106.5 per 100,000, slightly higher than for men (94.1 per 100,000). Reported gonorrhea rates were highest among adolescent girls ages 15 to19 years (570.9 per 100,000) and young women ages 20 to 24 years (560.7 per 100,000). The largest increases were observed among men and woman ages 20 to 24 years (4.9%) and 30 to 34 years (3.2%).³

“In the United States, about 300,000 cases of gonorrhea are reported each year, but because infected people often have no symptoms, the actual number of cases is probably closer to 700,000,” reported Gail Bolan, director of the CDC’s Sexually Transmitted Disease Prevention Division.⁴

GROWING CONCERN OVER RESISTANCE

Signs of growing resistance have only been seen in laboratory studies; there are no reported cases of treatment-resistant gonorrhea in the Unites States. However, the evidence of emerging cephalosporin resistance is following a similar pattern to that seen in 2007, when gonorrhea became fluoroquinolone-resistant.^1,5

“The challenge is that there is not a well-studied second antibiotic we can turn to even when cephalosporin resistance does emerge,” said Robert D. Kirkcaldy, a medical epidemiologist at the CDC. “What we’ve been noticing is really since 2009 and 2010, it’s taking higher concentrations of antibiotic to kill the bacteria. This could mean resistance to the last antibiotic we have for gonorrhea could be on the horizon.”⁵

NEW CDC TREATMENT RECOMMENDATIONS

The CDC’s updated guidelines include treatment plans for uncomplicated disease; specific alternatives if ceftriaxone cannot be used; test-of-cure procedures; treatment failure strategies; and recommendations for sexual partners.¹

Uncomplicated disease

To treat uncomplicated urogenital, anorectal, and pharyngeal gonorrhea, the CDC now recommends combination therapy with a single intramuscular dose of ceftriaxone 250 mg plus either a single dose of azithromycin 1 g orally or doxycycline 100 mg orally twice a day for 7 days.

Ceftriaxone, as a single 250-mg intramuscular injection, provides high and sustained bactericidal blood levels and is highly efficacious at all anatomic sites of N. gonorrhoeae infection currently circulating in the US. Clinical data are not available that support the use of an increased dose.

The percentage of isolates exhibiting tetracycline resistance was high but remained stable from 2006 (20.6%) to 2011 (21.6%).

Alternatives

When ceftriaxone cannot be used to treat urogenital or rectal gonorrhea, there are two options:

• if ceftriaxone is not readily available, give cefixime 400 mg orally plus either azithromycin 1 g orally or doxycycline 100 mg twice daily orally for 7 days
• if ceftriaxone cannot be given because of severe allergy, give azithromycin 2 g orally in a single dose.

A patient with gonorrhea treated with an alternative regimen should return 1 week after treatment for a test-of-cure at the infected anatomic site.

Test-of-cure—specimen culture is essential

The ideal test-of-cure is performed with culture or, if culture is not readily available, with a nucleic acid amplification testing (NAAT). If the NAAT is positive, make every effort to perform a confirmatory culture. All positive cultures for test-of-cure should undergo phenotypic antimicrobial susceptibility testing.

Unfortunately, the capacity of US laboratories to isolate N. gonorrhoeae by culture is declining rapidly because of the widespread use of NAATs for diagnosing gonorrhea. CDC reporters del Rio and colleagues write in MMWR:¹

• It is essential that culture capacity for N. gonorrhoeae be maintained to monitor antimicrobial resistance trends and determine susceptibility to guide treatment following treatment failure. To help control gonorrhea in the United States, health-care providers must maintain the ability to collect specimens for culture and be knowledgeable of laboratories to which they can send specimens for culture. Health-care systems and health departments must support access to culture, and laboratories must maintain culture capacity or develop partnerships with laboratories that can perform culture.

Treatment failure

Clinicians treating a patient with persistent infection after treatment with the recommended therapy should culture relevant clinical specimens and perform antimicrobial susceptibility testing of N. gonorrhoeae isolates. Phenotypic antimicrobial susceptibility testing should be performed using disk diffusion, Etest (BioMerieux), or agar dilution. Data are limited on the use of NAAT-based antimicrobial susceptibility testing for genetic mutations.

Patients who experience treatment failure after treatment with alternative regimens should be treated with ceftriaxone 250 mg as a single intramuscular dose and azithromycin 2 g orally as a single dose and should receive infectious disease consultation.

Consult an infectious disease specialist, an STD/HIV Prevention Training Center, or the CDC for treatment advice, and report the case to the CDC through a health department within 24 hours of diagnosis. Conduct test-of-cure 7 days after re-treatment.

Sexual partners

Clinicians should make every effort to ensure that the patient’s sex partners from the preceding 60 days are evaluated promptly and treated as indicated.

“Treatment of patients with gonorrhea with the most effective therapy will limit the transmission of the disease, prevent complications, and slow the emergence of resistance,” wrote CDC reporters. “However, resistance to cephalosporins, including ceftriaxone, is expected to emerge. Reinvestment in gonorrhea prevention and control is warranted. New treatment options for gonorrhea are urgently needed.”¹

For the full MMWR article on new gonorrhea treatment guidelines, visit http://1.usa.gov/OxjuaQ

We want to hear from you! Tell us what you think.

The US Food and Drug Administration (FDA) has approved Myrbetriq™ (mirabegron) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

“Myrbetriq is the first oral OAB treatment with a distinct mechanism of action since the launch of anticholinergic agents 30 years ago,” said Steven Ryder, MD, president of Astellas Pharma Global Development. “The approval of Myrbetriq represents an important milestone in OAB treatment and in our ongoing commitment to advancing urological health.” Astellas Pharma US, Inc., is a subsidiary of Tokyo-based Astellas Pharma Inc.

Myrbetriq, a once-daily oral beta-3 adrenergic agonist, offers a new treatment option for patients with OAB. Antimuscarinics, the current OAB treatment standard, work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions. Myrbetriq relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 adrenergic receptors, therefore increasing bladder capacity.

Myrbetriq has been studied in more than 10,000 individuals over 10 years. FDA approval was based on safety and efficacy data from three placebo-controlled Phase 3 studies in which treatment with Myrbetriq 25 mg and 50 mg resulted in statistically significantly improvement in efficacy parameters of incontinence episodes and number of urinations per 24 hours.

The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. The dose may be increased to 50 mg. Most commonly reported adverse reactions were hypertension, nasopharyngitis, urinary tract infection, and headache. Myrbetriq will be available in pharmacies in the fourth quarter of 2012.

For additional information, visit www.myrbetriq.com.

We want to hear from you! Tell us what you think.

The US Food and Drug Administration (FDA) has approved Myrbetriq™ (mirabegron) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

“Myrbetriq is the first oral OAB treatment with a distinct mechanism of action since the launch of anticholinergic agents 30 years ago,” said Steven Ryder, MD, president of Astellas Pharma Global Development. “The approval of Myrbetriq represents an important milestone in OAB treatment and in our ongoing commitment to advancing urological health.” Astellas Pharma US, Inc., is a subsidiary of Tokyo-based Astellas Pharma Inc.

Myrbetriq, a once-daily oral beta-3 adrenergic agonist, offers a new treatment option for patients with OAB. Antimuscarinics, the current OAB treatment standard, work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions. Myrbetriq relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 adrenergic receptors, therefore increasing bladder capacity.

Myrbetriq has been studied in more than 10,000 individuals over 10 years. FDA approval was based on safety and efficacy data from three placebo-controlled Phase 3 studies in which treatment with Myrbetriq 25 mg and 50 mg resulted in statistically significantly improvement in efficacy parameters of incontinence episodes and number of urinations per 24 hours.

The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. The dose may be increased to 50 mg. Most commonly reported adverse reactions were hypertension, nasopharyngitis, urinary tract infection, and headache. Myrbetriq will be available in pharmacies in the fourth quarter of 2012.

For additional information, visit www.myrbetriq.com.

We want to hear from you! Tell us what you think.

The US Food and Drug Administration (FDA) has approved Myrbetriq™ (mirabegron) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

“Myrbetriq is the first oral OAB treatment with a distinct mechanism of action since the launch of anticholinergic agents 30 years ago,” said Steven Ryder, MD, president of Astellas Pharma Global Development. “The approval of Myrbetriq represents an important milestone in OAB treatment and in our ongoing commitment to advancing urological health.” Astellas Pharma US, Inc., is a subsidiary of Tokyo-based Astellas Pharma Inc.

Myrbetriq, a once-daily oral beta-3 adrenergic agonist, offers a new treatment option for patients with OAB. Antimuscarinics, the current OAB treatment standard, work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions. Myrbetriq relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 adrenergic receptors, therefore increasing bladder capacity.

Myrbetriq has been studied in more than 10,000 individuals over 10 years. FDA approval was based on safety and efficacy data from three placebo-controlled Phase 3 studies in which treatment with Myrbetriq 25 mg and 50 mg resulted in statistically significantly improvement in efficacy parameters of incontinence episodes and number of urinations per 24 hours.

The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. The dose may be increased to 50 mg. Most commonly reported adverse reactions were hypertension, nasopharyngitis, urinary tract infection, and headache. Myrbetriq will be available in pharmacies in the fourth quarter of 2012.

For additional information, visit www.myrbetriq.com.

We want to hear from you! Tell us what you think.

Johnson & Johnson’s Ethicon division recently announced it will not continue to market four vaginal mesh implants that have been the subject of lawsuits for having caused serious internal injuries. In response, Congressman Edward J. Markey (D-Mass.), praised the corporation’s wise choice.

“Johnson & Johnson’s decision to stop marketing the mesh implant that caused massive internal injuries to thousands of women is a welcome announcement,” writes Markey, senior member of the Energy and Commerce Committee.¹

The June 4 letter from Ethicon to the FDA names four meshes: Gynecare TVT Secur™ System, Gynecare Prosima™ Pelvic Floor Repair System, Gynecare Prolift™ Pelvic Floor Repair System, and Gynecare Prolift+M™ Pelvic Floor Repair System.²

Concerning Ethicon’s letter, Matthew Johnson, a J&J spokesman, is quoted in a Bloomberg report: “The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices. The company won’t withdraw the Prolift before its ‘planned discontinuation’ of the mesh products over the next 3 to 9 months.”³

Johnson wrote: “J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA.”³

A more profound problem

Congressman Markey stresses that there is a deeper problem: a loophole in the FDA approval process for medical devices. Under the current 510(k) process, a device does not need to undergo clinical testing in humans before being sold. Instead, the FDA clears the device based on its similarity to a product already on the market, known as a “predicate.” Once a device has been cleared by showing that it is substantially equivalent to another product, it can become a predicate for future devices. The problem arises when a predicate has been removed from the market because its use places patients at risk.¹

“The FDA approves more than two dozen medical devices per year based on a previous product that has since been recalled even though these devices are five times more likely to be recalled themselves,” reports Markey.

Legislation to help the FDA reject a device

In February, Markey, with Henry A. Waxman (D-Calif), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill will allow the FDA to reject a device if it is based on an earlier product that has been recalled for causing serious harm to patients.

“This legislation fixes a glaring loophole in that regulatory framework. It gives FDA authority to deny clearance if the predicate on which the clearance is based was voluntarily recalled because it was unsafe due to an intrinsic flaw in its design or technology,” writes Rep. Waxman.⁴

We want to hear from you! Tell us what you think.

Johnson & Johnson’s Ethicon division recently announced it will not continue to market four vaginal mesh implants that have been the subject of lawsuits for having caused serious internal injuries. In response, Congressman Edward J. Markey (D-Mass.), praised the corporation’s wise choice.

“Johnson & Johnson’s decision to stop marketing the mesh implant that caused massive internal injuries to thousands of women is a welcome announcement,” writes Markey, senior member of the Energy and Commerce Committee.¹

The June 4 letter from Ethicon to the FDA names four meshes: Gynecare TVT Secur™ System, Gynecare Prosima™ Pelvic Floor Repair System, Gynecare Prolift™ Pelvic Floor Repair System, and Gynecare Prolift+M™ Pelvic Floor Repair System.²

Concerning Ethicon’s letter, Matthew Johnson, a J&J spokesman, is quoted in a Bloomberg report: “The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices. The company won’t withdraw the Prolift before its ‘planned discontinuation’ of the mesh products over the next 3 to 9 months.”³

Johnson wrote: “J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA.”³

A more profound problem

Congressman Markey stresses that there is a deeper problem: a loophole in the FDA approval process for medical devices. Under the current 510(k) process, a device does not need to undergo clinical testing in humans before being sold. Instead, the FDA clears the device based on its similarity to a product already on the market, known as a “predicate.” Once a device has been cleared by showing that it is substantially equivalent to another product, it can become a predicate for future devices. The problem arises when a predicate has been removed from the market because its use places patients at risk.¹

“The FDA approves more than two dozen medical devices per year based on a previous product that has since been recalled even though these devices are five times more likely to be recalled themselves,” reports Markey.

Legislation to help the FDA reject a device

In February, Markey, with Henry A. Waxman (D-Calif), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill will allow the FDA to reject a device if it is based on an earlier product that has been recalled for causing serious harm to patients.

“This legislation fixes a glaring loophole in that regulatory framework. It gives FDA authority to deny clearance if the predicate on which the clearance is based was voluntarily recalled because it was unsafe due to an intrinsic flaw in its design or technology,” writes Rep. Waxman.⁴

We want to hear from you! Tell us what you think.

Johnson & Johnson’s Ethicon division recently announced it will not continue to market four vaginal mesh implants that have been the subject of lawsuits for having caused serious internal injuries. In response, Congressman Edward J. Markey (D-Mass.), praised the corporation’s wise choice.

“Johnson & Johnson’s decision to stop marketing the mesh implant that caused massive internal injuries to thousands of women is a welcome announcement,” writes Markey, senior member of the Energy and Commerce Committee.¹

The June 4 letter from Ethicon to the FDA names four meshes: Gynecare TVT Secur™ System, Gynecare Prosima™ Pelvic Floor Repair System, Gynecare Prolift™ Pelvic Floor Repair System, and Gynecare Prolift+M™ Pelvic Floor Repair System.²

Concerning Ethicon’s letter, Matthew Johnson, a J&J spokesman, is quoted in a Bloomberg report: “The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices. The company won’t withdraw the Prolift before its ‘planned discontinuation’ of the mesh products over the next 3 to 9 months.”³

Johnson wrote: “J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA.”³

A more profound problem

Congressman Markey stresses that there is a deeper problem: a loophole in the FDA approval process for medical devices. Under the current 510(k) process, a device does not need to undergo clinical testing in humans before being sold. Instead, the FDA clears the device based on its similarity to a product already on the market, known as a “predicate.” Once a device has been cleared by showing that it is substantially equivalent to another product, it can become a predicate for future devices. The problem arises when a predicate has been removed from the market because its use places patients at risk.¹

“The FDA approves more than two dozen medical devices per year based on a previous product that has since been recalled even though these devices are five times more likely to be recalled themselves,” reports Markey.

Legislation to help the FDA reject a device

In February, Markey, with Henry A. Waxman (D-Calif), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill will allow the FDA to reject a device if it is based on an earlier product that has been recalled for causing serious harm to patients.

“This legislation fixes a glaring loophole in that regulatory framework. It gives FDA authority to deny clearance if the predicate on which the clearance is based was voluntarily recalled because it was unsafe due to an intrinsic flaw in its design or technology,” writes Rep. Waxman.⁴

We want to hear from you! Tell us what you think.

Concern over a relationship between in vitro fertilization (IVF) and subsequent breast cancer has been ameliorated by a large study conducted in Australia. The authors report no overall increase in the rate of breast cancer in women who undergo IVF. However, there does seem to be a higher risk of breast cancer in those who begin IVF treatment when in their mid-20s.

A population-based study from Western Australia studied the incidence rate of breast cancer in a large cohort (n=21,025) aged 20 to 44 years who underwent hospital-based treatment for infertility. Researchers compared the rate of breast cancer in women who had IVF with those who had fertility treatment but not IVF.

The study, published in Fertility and Sterility, reports that there is no overall increase in the risk of breast cancer for women who undergo hospital-based IVF (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.88–1.36).

“For younger women,” write the authors, “there is some cause for concern, because it appears that they may face an increased risk of breast cancer after IVF treatment.”

Women who began hospital infertility treatment at 24 years of age and required IVF had an unadjusted HR of breast cancer of 1.59 (95% CI, 1.05–2.42) compared with women of the same age who had infertility treatment but no IVF.

When adjusted for late age at first delivery, which is associated with an increased rate of breast cancer, and delivery of twins and higher-order multiples, which is associated with a decreased rate of breast cancer, the HR remained elevated at 1.56 (95% CI, 1.01–2.40).

“The results of this study will be reassuring to women who commence IVF treatment in their 30s and 40s because, for these women, there appears to be no direct association between IVF treatment and breast cancer risk,” write the authors. Risk was not elevated in women who commenced treatment at age 40 and required IVF (adjusted HR, 0.87; 95% CI, 0.62–1.22).

“Nevertheless, women should be aware that delivering their first child late in reproductive life, whether assisted by IVF or not, is associated with an increased risk of breast cancer.”

Access to the full-text article is available at http://bit.ly/KiLvwh.

Concern over a relationship between in vitro fertilization (IVF) and subsequent breast cancer has been ameliorated by a large study conducted in Australia. The authors report no overall increase in the rate of breast cancer in women who undergo IVF. However, there does seem to be a higher risk of breast cancer in those who begin IVF treatment when in their mid-20s.

A population-based study from Western Australia studied the incidence rate of breast cancer in a large cohort (n=21,025) aged 20 to 44 years who underwent hospital-based treatment for infertility. Researchers compared the rate of breast cancer in women who had IVF with those who had fertility treatment but not IVF.

The study, published in Fertility and Sterility, reports that there is no overall increase in the risk of breast cancer for women who undergo hospital-based IVF (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.88–1.36).

“For younger women,” write the authors, “there is some cause for concern, because it appears that they may face an increased risk of breast cancer after IVF treatment.”

Women who began hospital infertility treatment at 24 years of age and required IVF had an unadjusted HR of breast cancer of 1.59 (95% CI, 1.05–2.42) compared with women of the same age who had infertility treatment but no IVF.

When adjusted for late age at first delivery, which is associated with an increased rate of breast cancer, and delivery of twins and higher-order multiples, which is associated with a decreased rate of breast cancer, the HR remained elevated at 1.56 (95% CI, 1.01–2.40).

“The results of this study will be reassuring to women who commence IVF treatment in their 30s and 40s because, for these women, there appears to be no direct association between IVF treatment and breast cancer risk,” write the authors. Risk was not elevated in women who commenced treatment at age 40 and required IVF (adjusted HR, 0.87; 95% CI, 0.62–1.22).

“Nevertheless, women should be aware that delivering their first child late in reproductive life, whether assisted by IVF or not, is associated with an increased risk of breast cancer.”

Access to the full-text article is available at http://bit.ly/KiLvwh.

Concern over a relationship between in vitro fertilization (IVF) and subsequent breast cancer has been ameliorated by a large study conducted in Australia. The authors report no overall increase in the rate of breast cancer in women who undergo IVF. However, there does seem to be a higher risk of breast cancer in those who begin IVF treatment when in their mid-20s.

A population-based study from Western Australia studied the incidence rate of breast cancer in a large cohort (n=21,025) aged 20 to 44 years who underwent hospital-based treatment for infertility. Researchers compared the rate of breast cancer in women who had IVF with those who had fertility treatment but not IVF.

The study, published in Fertility and Sterility, reports that there is no overall increase in the risk of breast cancer for women who undergo hospital-based IVF (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.88–1.36).

“For younger women,” write the authors, “there is some cause for concern, because it appears that they may face an increased risk of breast cancer after IVF treatment.”

Women who began hospital infertility treatment at 24 years of age and required IVF had an unadjusted HR of breast cancer of 1.59 (95% CI, 1.05–2.42) compared with women of the same age who had infertility treatment but no IVF.

When adjusted for late age at first delivery, which is associated with an increased rate of breast cancer, and delivery of twins and higher-order multiples, which is associated with a decreased rate of breast cancer, the HR remained elevated at 1.56 (95% CI, 1.01–2.40).

“The results of this study will be reassuring to women who commence IVF treatment in their 30s and 40s because, for these women, there appears to be no direct association between IVF treatment and breast cancer risk,” write the authors. Risk was not elevated in women who commenced treatment at age 40 and required IVF (adjusted HR, 0.87; 95% CI, 0.62–1.22).

“Nevertheless, women should be aware that delivering their first child late in reproductive life, whether assisted by IVF or not, is associated with an increased risk of breast cancer.”

Access to the full-text article is available at http://bit.ly/KiLvwh.

After a review of recent epidemiologic studies, the US Food and Drug Administration (FDA) concluded that there is a higher risk of blood clots in women taking drospirenone-containing oral contraceptives (OCs) than in women taking other progestin-containing OCs.

The FDA now requires that manufacturers add this information to the labels of drospirenone-containing OCs.

Before prescribing these drugs, health-care professionals are strongly advised to weigh the risks and benefits of drospirenone-containing OCs against a woman’s other risk factors for developing a blood clot.

Oral contraceptives that contain drospirenone/ethinyl estradiol are Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

Inconsistent results

The studies reviewed by the FDA did not provide consistent estimates of the comparative risk of blood clots associated with various oral contraceptives that did or did not contain drospirenone. Nor did they account for patient characteristics that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk of blood clots seen in some of the studies is actually due to drospirenone-containing OCs.

Bayer, the manufacturer of Beyaz, Safyral, Yasmin, and Yaz, will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products, compared with products containing levonorgestrel or some other progestinsâ€"whereas other epidemiologic studies found no additional risk of blood clots. The labels will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

Risk is still lower than in pregnancy and postpartum

The FDA notes: "To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period."1

The likelihood of developing a blood clot is greatest (40 to 65 cases for every 10,000 women) during the postpartum period; moderately risky (5 to 20 for every 10,000) during pregnancy; less risky (3 to 9 for every 10,000) in combination oral contraceptive users; and least risky (1 to 5 for every 10,000) for nonpregnant, noncombination oral contraceptive users.1

For the US FDA Drug Safety Communication published on April 10, 2012, click here.

We want to hear from you!  Tell us what you think.

After a review of recent epidemiologic studies, the US Food and Drug Administration (FDA) concluded that there is a higher risk of blood clots in women taking drospirenone-containing oral contraceptives (OCs) than in women taking other progestin-containing OCs.

The FDA now requires that manufacturers add this information to the labels of drospirenone-containing OCs.

Before prescribing these drugs, health-care professionals are strongly advised to weigh the risks and benefits of drospirenone-containing OCs against a woman’s other risk factors for developing a blood clot.

Oral contraceptives that contain drospirenone/ethinyl estradiol are Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

Inconsistent results

The studies reviewed by the FDA did not provide consistent estimates of the comparative risk of blood clots associated with various oral contraceptives that did or did not contain drospirenone. Nor did they account for patient characteristics that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk of blood clots seen in some of the studies is actually due to drospirenone-containing OCs.

Bayer, the manufacturer of Beyaz, Safyral, Yasmin, and Yaz, will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products, compared with products containing levonorgestrel or some other progestinsâ€"whereas other epidemiologic studies found no additional risk of blood clots. The labels will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

Risk is still lower than in pregnancy and postpartum

The FDA notes: "To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period."1

The likelihood of developing a blood clot is greatest (40 to 65 cases for every 10,000 women) during the postpartum period; moderately risky (5 to 20 for every 10,000) during pregnancy; less risky (3 to 9 for every 10,000) in combination oral contraceptive users; and least risky (1 to 5 for every 10,000) for nonpregnant, noncombination oral contraceptive users.1

For the US FDA Drug Safety Communication published on April 10, 2012, click here.

We want to hear from you!  Tell us what you think.

After a review of recent epidemiologic studies, the US Food and Drug Administration (FDA) concluded that there is a higher risk of blood clots in women taking drospirenone-containing oral contraceptives (OCs) than in women taking other progestin-containing OCs.

The FDA now requires that manufacturers add this information to the labels of drospirenone-containing OCs.

Before prescribing these drugs, health-care professionals are strongly advised to weigh the risks and benefits of drospirenone-containing OCs against a woman’s other risk factors for developing a blood clot.

Oral contraceptives that contain drospirenone/ethinyl estradiol are Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

Inconsistent results

The studies reviewed by the FDA did not provide consistent estimates of the comparative risk of blood clots associated with various oral contraceptives that did or did not contain drospirenone. Nor did they account for patient characteristics that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk of blood clots seen in some of the studies is actually due to drospirenone-containing OCs.

Bayer, the manufacturer of Beyaz, Safyral, Yasmin, and Yaz, will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products, compared with products containing levonorgestrel or some other progestinsâ€"whereas other epidemiologic studies found no additional risk of blood clots. The labels will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

Risk is still lower than in pregnancy and postpartum

The FDA notes: "To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period."1

The likelihood of developing a blood clot is greatest (40 to 65 cases for every 10,000 women) during the postpartum period; moderately risky (5 to 20 for every 10,000) during pregnancy; less risky (3 to 9 for every 10,000) in combination oral contraceptive users; and least risky (1 to 5 for every 10,000) for nonpregnant, noncombination oral contraceptive users.1

For the US FDA Drug Safety Communication published on April 10, 2012, click here.

We want to hear from you!  Tell us what you think.

Experience from research and practice have demonstrated that venous thromboembolism (VTE) is a common complication of hormone therapy. Now, that obstacle to safe treatment of the symptoms of menopause may be tempered by the results of a large population-based study, suggesting that patients who take transdermal estradiol have a 30% lower incidence of VTE than those who take oral estrogen only. The lower risk of VTE was also statistically significant when transdermal estradiol was at high dose.^1,2

Study results were presented at the 22nd Annual Meeting of the North American Menopause Society (NAMS) in Washington, DC, in September.

In the retrospective, matched-cohort study that compared high-dose transdermal estradiol and oral estrogen-only HT agents, 115 of 27,018 users of the estradiol transdermal system (ETS) and 164 of 27,018 users of the oral estrogen developed VTE. In those taking high-dose ETS (0.1 mg/day), 32 of 8,956 ETS users and 65 of 8,956 oral users of high dose oral estrogen developed VTE.^1,2

“The incidence of hospitalization related to VTE events among the ETS users was also significantly lower, relative to the oral-only hormone therapy users,” said Eric Beresford, PharmD, presenter and coauthor of the study and director of medical affairs at Forest Research Institute, Secaucus, NJ, who previously worked at Novartis.¹

2011-2012 NAMS President JoAnn Manson, MD, DrPH, HCMP, commented that the study “provides further reassurance that transdermal estrogen may not increase the risk of venous thrombosis.”¹

“We do know that transdermal products don’t go directly to the liver and don’t increase the production of clotting proteins to the same extent as the oral estrogen products,” Manson added, “so it’s biologically very plausible. I do think that it’s a reasonable choice for trying to avoid venous thrombosis risk.”¹

For details: www.medscape.com/viewarticle/750558.

We want to hear from you! Tell us what you think.

Experience from research and practice have demonstrated that venous thromboembolism (VTE) is a common complication of hormone therapy. Now, that obstacle to safe treatment of the symptoms of menopause may be tempered by the results of a large population-based study, suggesting that patients who take transdermal estradiol have a 30% lower incidence of VTE than those who take oral estrogen only. The lower risk of VTE was also statistically significant when transdermal estradiol was at high dose.^1,2

Study results were presented at the 22nd Annual Meeting of the North American Menopause Society (NAMS) in Washington, DC, in September.

In the retrospective, matched-cohort study that compared high-dose transdermal estradiol and oral estrogen-only HT agents, 115 of 27,018 users of the estradiol transdermal system (ETS) and 164 of 27,018 users of the oral estrogen developed VTE. In those taking high-dose ETS (0.1 mg/day), 32 of 8,956 ETS users and 65 of 8,956 oral users of high dose oral estrogen developed VTE.^1,2

“The incidence of hospitalization related to VTE events among the ETS users was also significantly lower, relative to the oral-only hormone therapy users,” said Eric Beresford, PharmD, presenter and coauthor of the study and director of medical affairs at Forest Research Institute, Secaucus, NJ, who previously worked at Novartis.¹

2011-2012 NAMS President JoAnn Manson, MD, DrPH, HCMP, commented that the study “provides further reassurance that transdermal estrogen may not increase the risk of venous thrombosis.”¹

“We do know that transdermal products don’t go directly to the liver and don’t increase the production of clotting proteins to the same extent as the oral estrogen products,” Manson added, “so it’s biologically very plausible. I do think that it’s a reasonable choice for trying to avoid venous thrombosis risk.”¹

For details: www.medscape.com/viewarticle/750558.

We want to hear from you! Tell us what you think.

Experience from research and practice have demonstrated that venous thromboembolism (VTE) is a common complication of hormone therapy. Now, that obstacle to safe treatment of the symptoms of menopause may be tempered by the results of a large population-based study, suggesting that patients who take transdermal estradiol have a 30% lower incidence of VTE than those who take oral estrogen only. The lower risk of VTE was also statistically significant when transdermal estradiol was at high dose.^1,2

Study results were presented at the 22nd Annual Meeting of the North American Menopause Society (NAMS) in Washington, DC, in September.

In the retrospective, matched-cohort study that compared high-dose transdermal estradiol and oral estrogen-only HT agents, 115 of 27,018 users of the estradiol transdermal system (ETS) and 164 of 27,018 users of the oral estrogen developed VTE. In those taking high-dose ETS (0.1 mg/day), 32 of 8,956 ETS users and 65 of 8,956 oral users of high dose oral estrogen developed VTE.^1,2

“The incidence of hospitalization related to VTE events among the ETS users was also significantly lower, relative to the oral-only hormone therapy users,” said Eric Beresford, PharmD, presenter and coauthor of the study and director of medical affairs at Forest Research Institute, Secaucus, NJ, who previously worked at Novartis.¹

2011-2012 NAMS President JoAnn Manson, MD, DrPH, HCMP, commented that the study “provides further reassurance that transdermal estrogen may not increase the risk of venous thrombosis.”¹

“We do know that transdermal products don’t go directly to the liver and don’t increase the production of clotting proteins to the same extent as the oral estrogen products,” Manson added, “so it’s biologically very plausible. I do think that it’s a reasonable choice for trying to avoid venous thrombosis risk.”¹

For details: www.medscape.com/viewarticle/750558.

We want to hear from you! Tell us what you think.

Daughters of known carriers of BRCA1 or BRCA2 gene mutations are understandably stressed, reported A. Farkas Patenaude, PhD, in a paper, “What do young adult daughters of BRCA mutation carriers know about hereditary risk and how much do they worry,” presented at The Era of Hope Conference in Orlando, Florida, August 2–6.

These 18-to-24-year-olds are at a 50% to 85% risk for breast and related ovarian cancers²—significantly more so than that of the general population (at 30 years, a 0.43% risk).¹ In addition, these types of breast and ovarian cancer often occur at an unusually young age.²

Although ACOG recommends that annual screening mammograms begin at age 40,³ daughters of women who are known gene-mutation carriers should begin screening mammography at age 25.⁴ The ability of these women to make informed health decisions depends on their becoming knowledgeable about the risks, the availability of genetic testing, and options for screening and risk-reducing prophylactic surgery.

Although the daughters expressed worry about hereditary breast cancer, they had limited understanding of screening and risk-reduction options. If they did have the information, Dr. Patenaude’s study found, the young women were often afraid to have the testing.^2,4

“Young, high-risk women have little knowledge about the probabilities and options for managing the cancers for which their risks are remarkably increased. Further, many report intense anxiety related to their potential cancer development,” said Dr. Patenaude of the Dana Farber Cancer Institute. “These data support the need and can provide the foundation for the development of targeted educational materials to reduce that anxiety and ultimately improve participation in effective screening and risk-reducing interventions that can improve survival and quality of life for these young women.”²

The Era of Hope Conference provides a forum for scientists and clinicians from a variety of disciplines to join breast cancer survivors and advocates to discuss the advances made by the Congressionally Directed Breast Cancer Research Programs BCRP awardees, and to identify innovative, high-impact approaches for future research. Recognized as one of the premiere breast cancer research meetings.⁵

We want to hear from you! Tell us what you think.

Daughters of known carriers of BRCA1 or BRCA2 gene mutations are understandably stressed, reported A. Farkas Patenaude, PhD, in a paper, “What do young adult daughters of BRCA mutation carriers know about hereditary risk and how much do they worry,” presented at The Era of Hope Conference in Orlando, Florida, August 2–6.

These 18-to-24-year-olds are at a 50% to 85% risk for breast and related ovarian cancers²—significantly more so than that of the general population (at 30 years, a 0.43% risk).¹ In addition, these types of breast and ovarian cancer often occur at an unusually young age.²

Although ACOG recommends that annual screening mammograms begin at age 40,³ daughters of women who are known gene-mutation carriers should begin screening mammography at age 25.⁴ The ability of these women to make informed health decisions depends on their becoming knowledgeable about the risks, the availability of genetic testing, and options for screening and risk-reducing prophylactic surgery.

Although the daughters expressed worry about hereditary breast cancer, they had limited understanding of screening and risk-reduction options. If they did have the information, Dr. Patenaude’s study found, the young women were often afraid to have the testing.^2,4

“Young, high-risk women have little knowledge about the probabilities and options for managing the cancers for which their risks are remarkably increased. Further, many report intense anxiety related to their potential cancer development,” said Dr. Patenaude of the Dana Farber Cancer Institute. “These data support the need and can provide the foundation for the development of targeted educational materials to reduce that anxiety and ultimately improve participation in effective screening and risk-reducing interventions that can improve survival and quality of life for these young women.”²

The Era of Hope Conference provides a forum for scientists and clinicians from a variety of disciplines to join breast cancer survivors and advocates to discuss the advances made by the Congressionally Directed Breast Cancer Research Programs BCRP awardees, and to identify innovative, high-impact approaches for future research. Recognized as one of the premiere breast cancer research meetings.⁵

We want to hear from you! Tell us what you think.

Daughters of known carriers of BRCA1 or BRCA2 gene mutations are understandably stressed, reported A. Farkas Patenaude, PhD, in a paper, “What do young adult daughters of BRCA mutation carriers know about hereditary risk and how much do they worry,” presented at The Era of Hope Conference in Orlando, Florida, August 2–6.

These 18-to-24-year-olds are at a 50% to 85% risk for breast and related ovarian cancers²—significantly more so than that of the general population (at 30 years, a 0.43% risk).¹ In addition, these types of breast and ovarian cancer often occur at an unusually young age.²

Although ACOG recommends that annual screening mammograms begin at age 40,³ daughters of women who are known gene-mutation carriers should begin screening mammography at age 25.⁴ The ability of these women to make informed health decisions depends on their becoming knowledgeable about the risks, the availability of genetic testing, and options for screening and risk-reducing prophylactic surgery.

Although the daughters expressed worry about hereditary breast cancer, they had limited understanding of screening and risk-reduction options. If they did have the information, Dr. Patenaude’s study found, the young women were often afraid to have the testing.^2,4

“Young, high-risk women have little knowledge about the probabilities and options for managing the cancers for which their risks are remarkably increased. Further, many report intense anxiety related to their potential cancer development,” said Dr. Patenaude of the Dana Farber Cancer Institute. “These data support the need and can provide the foundation for the development of targeted educational materials to reduce that anxiety and ultimately improve participation in effective screening and risk-reducing interventions that can improve survival and quality of life for these young women.”²

The Era of Hope Conference provides a forum for scientists and clinicians from a variety of disciplines to join breast cancer survivors and advocates to discuss the advances made by the Congressionally Directed Breast Cancer Research Programs BCRP awardees, and to identify innovative, high-impact approaches for future research. Recognized as one of the premiere breast cancer research meetings.⁵

We want to hear from you! Tell us what you think.

Beginning in August 2012, new health plans must offer expanded women’s preventive health coverage with no cost sharing, announced Kathleen Sebelius, Secretary of Health and Human Services. This expanded definition will become part of the Affordable Care Act.¹

Following recent guideline changes from the Institute of Medicine, women’s preventive care will include yearly wellness visits, breastfeeding counseling and equipment, free birth control, and screening for gestational diabetes, domestic abuse, HPV, sexually transmitted infections, and HIV.^1,2

Women will have access to all FDA-approved forms of contraception (including emergency contraceptives),³ sterilization procedures, and patient education and counseling. However, religious institutions that offer health insurance to their employees may choose not to offer birth control.^1-3

No cost sharing includes co-pays, co-insurance, and deductibles. However, an insurer may charge a co-pay for brand-name drugs if a lower-cost generic version is available and is proven just as safe and effective.^1-3

The Guidelines for Women’s Preventive Services are available at: www.hrsa.gov/womensguidelines/

Beginning in August 2012, new health plans must offer expanded women’s preventive health coverage with no cost sharing, announced Kathleen Sebelius, Secretary of Health and Human Services. This expanded definition will become part of the Affordable Care Act.¹

Following recent guideline changes from the Institute of Medicine, women’s preventive care will include yearly wellness visits, breastfeeding counseling and equipment, free birth control, and screening for gestational diabetes, domestic abuse, HPV, sexually transmitted infections, and HIV.^1,2

Women will have access to all FDA-approved forms of contraception (including emergency contraceptives),³ sterilization procedures, and patient education and counseling. However, religious institutions that offer health insurance to their employees may choose not to offer birth control.^1-3

No cost sharing includes co-pays, co-insurance, and deductibles. However, an insurer may charge a co-pay for brand-name drugs if a lower-cost generic version is available and is proven just as safe and effective.^1-3

The Guidelines for Women’s Preventive Services are available at: www.hrsa.gov/womensguidelines/

Beginning in August 2012, new health plans must offer expanded women’s preventive health coverage with no cost sharing, announced Kathleen Sebelius, Secretary of Health and Human Services. This expanded definition will become part of the Affordable Care Act.¹

Following recent guideline changes from the Institute of Medicine, women’s preventive care will include yearly wellness visits, breastfeeding counseling and equipment, free birth control, and screening for gestational diabetes, domestic abuse, HPV, sexually transmitted infections, and HIV.^1,2

Women will have access to all FDA-approved forms of contraception (including emergency contraceptives),³ sterilization procedures, and patient education and counseling. However, religious institutions that offer health insurance to their employees may choose not to offer birth control.^1-3

No cost sharing includes co-pays, co-insurance, and deductibles. However, an insurer may charge a co-pay for brand-name drugs if a lower-cost generic version is available and is proven just as safe and effective.^1-3

The Guidelines for Women’s Preventive Services are available at: www.hrsa.gov/womensguidelines/