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Analysis shows antacids do not slow IPF progression
Idiopathic pulmonary fibrosis (IPF) progressed at similar rates in patients who did and did not receive antacid therapy, based on a post hoc analysis of 52-week data from patients in three placebo-controlled trials.
“We found no association between antacid therapy and progression-free survival, mortality, or adverse events, reported Dr. Michael Krueter of the University of Heidelberg, Germany, and his colleagues (Lancet Respir Med. 2016 Mar 31;S2213-2600[16]00067-9). Further, patients who took antacids and had less than 70% forced vital capacity (FVC) had higher rates of pulmonary and nonpulmonary infections than did patients who did not receive antacid therapy.
“Long-term double-blind randomized studies are urgently needed to further investigate the potential benefit (and possible harms) of antacid therapy in patients with different stages of IPF, especially those with advanced disease,” the researchers said.
The findings challenge the conditional recommendation for antacid use in the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines on the treatment of IPF. That advice was based on previous retrospective studies that indicated antacid users had slower IPF progression, fewer acute exacerbations, and improved survival compared to patients who did not take antacids.
The new study looked at IPF patients in the placebo groups in three large, phase III trials of pirfenidone. In the placebo groups of those studies, 291 patients were receiving antacid therapy and 333 patients were not receiving antacid therapy at baseline. At 1 year, the rates of disease progression in the placebo group were not significantly different – 38% in the antacid users and 42% in those not using antacids. Disease progression was the composite endpoint of death, an absolute FVC decrease of at least 10%, and a decrease of 50 meters or more in the 6-minute walk distance (6MWD). In both groups of patients, the rates of all-cause mortality were also similar.
The risk of death from IPF at 1 year also was not significantly different; 3.9% for antacid users and 5.2% for those not using antacids.
When patients were grouped on the basis of FVC at baseline – either less than 70% FVC or at least 70% FVC or greater – little or no difference was seen in disease mortality, disease progression, changes in FVC, 6MWD, and all-cause hospital admission between patients who received antacids and those who did not receive antacids at baseline.
Prior to stratification by baseline FVC, the rates of all-cause hospital admissions, gastrointestinal adverse effects, infections, and pulmonary infections were similar for the two groups of patients. At 52 weeks, however, infections and pulmonary infections were significantly higher in patients who received antacid therapy at baseline compared with those patients who did not receive antacids at baseline (74% vs. 62%; P = .0174 and 14% vs. 6%; P = .0214, respectively).
Unlike the patients in the previous retrospective studies, few patients in the placebo arms of the clinical trials had advanced IPF and low FVC, the researchers noted. All had IPF that had been diagnosed within 48 months of entering a trial, no evidence of improvement in disease severity in the year preceding trial entry, a predicted FVC of 50% or more, and a 6MWD of 150 meters or more. Among the patients receiving antacid therapy at baseline, 88% used proton-pump inhibitors, 8% used H2 blockers and 4% used proton-pump inhibitors and H2 blockers. Of the 291 patients receiving antacid therapy, 38 stopped after baseline; of the 333 not receiving antacid therapy, 83 started receiving the therapy after baseline.
Dr. Kreuter disclosed ties with Boehringer Ingelheim and InterMune/Roche. Two coauthors disclosed ties with F. Hoffmann-La Roche, which funded the study: Derek Weycker, Ph.D., reported receiving funding from the company, and Dr. Klaus-Uwe Kirchgaessler is an employee.
Idiopathic pulmonary fibrosis (IPF) progressed at similar rates in patients who did and did not receive antacid therapy, based on a post hoc analysis of 52-week data from patients in three placebo-controlled trials.
“We found no association between antacid therapy and progression-free survival, mortality, or adverse events, reported Dr. Michael Krueter of the University of Heidelberg, Germany, and his colleagues (Lancet Respir Med. 2016 Mar 31;S2213-2600[16]00067-9). Further, patients who took antacids and had less than 70% forced vital capacity (FVC) had higher rates of pulmonary and nonpulmonary infections than did patients who did not receive antacid therapy.
“Long-term double-blind randomized studies are urgently needed to further investigate the potential benefit (and possible harms) of antacid therapy in patients with different stages of IPF, especially those with advanced disease,” the researchers said.
The findings challenge the conditional recommendation for antacid use in the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines on the treatment of IPF. That advice was based on previous retrospective studies that indicated antacid users had slower IPF progression, fewer acute exacerbations, and improved survival compared to patients who did not take antacids.
The new study looked at IPF patients in the placebo groups in three large, phase III trials of pirfenidone. In the placebo groups of those studies, 291 patients were receiving antacid therapy and 333 patients were not receiving antacid therapy at baseline. At 1 year, the rates of disease progression in the placebo group were not significantly different – 38% in the antacid users and 42% in those not using antacids. Disease progression was the composite endpoint of death, an absolute FVC decrease of at least 10%, and a decrease of 50 meters or more in the 6-minute walk distance (6MWD). In both groups of patients, the rates of all-cause mortality were also similar.
The risk of death from IPF at 1 year also was not significantly different; 3.9% for antacid users and 5.2% for those not using antacids.
When patients were grouped on the basis of FVC at baseline – either less than 70% FVC or at least 70% FVC or greater – little or no difference was seen in disease mortality, disease progression, changes in FVC, 6MWD, and all-cause hospital admission between patients who received antacids and those who did not receive antacids at baseline.
Prior to stratification by baseline FVC, the rates of all-cause hospital admissions, gastrointestinal adverse effects, infections, and pulmonary infections were similar for the two groups of patients. At 52 weeks, however, infections and pulmonary infections were significantly higher in patients who received antacid therapy at baseline compared with those patients who did not receive antacids at baseline (74% vs. 62%; P = .0174 and 14% vs. 6%; P = .0214, respectively).
Unlike the patients in the previous retrospective studies, few patients in the placebo arms of the clinical trials had advanced IPF and low FVC, the researchers noted. All had IPF that had been diagnosed within 48 months of entering a trial, no evidence of improvement in disease severity in the year preceding trial entry, a predicted FVC of 50% or more, and a 6MWD of 150 meters or more. Among the patients receiving antacid therapy at baseline, 88% used proton-pump inhibitors, 8% used H2 blockers and 4% used proton-pump inhibitors and H2 blockers. Of the 291 patients receiving antacid therapy, 38 stopped after baseline; of the 333 not receiving antacid therapy, 83 started receiving the therapy after baseline.
Dr. Kreuter disclosed ties with Boehringer Ingelheim and InterMune/Roche. Two coauthors disclosed ties with F. Hoffmann-La Roche, which funded the study: Derek Weycker, Ph.D., reported receiving funding from the company, and Dr. Klaus-Uwe Kirchgaessler is an employee.
Idiopathic pulmonary fibrosis (IPF) progressed at similar rates in patients who did and did not receive antacid therapy, based on a post hoc analysis of 52-week data from patients in three placebo-controlled trials.
“We found no association between antacid therapy and progression-free survival, mortality, or adverse events, reported Dr. Michael Krueter of the University of Heidelberg, Germany, and his colleagues (Lancet Respir Med. 2016 Mar 31;S2213-2600[16]00067-9). Further, patients who took antacids and had less than 70% forced vital capacity (FVC) had higher rates of pulmonary and nonpulmonary infections than did patients who did not receive antacid therapy.
“Long-term double-blind randomized studies are urgently needed to further investigate the potential benefit (and possible harms) of antacid therapy in patients with different stages of IPF, especially those with advanced disease,” the researchers said.
The findings challenge the conditional recommendation for antacid use in the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines on the treatment of IPF. That advice was based on previous retrospective studies that indicated antacid users had slower IPF progression, fewer acute exacerbations, and improved survival compared to patients who did not take antacids.
The new study looked at IPF patients in the placebo groups in three large, phase III trials of pirfenidone. In the placebo groups of those studies, 291 patients were receiving antacid therapy and 333 patients were not receiving antacid therapy at baseline. At 1 year, the rates of disease progression in the placebo group were not significantly different – 38% in the antacid users and 42% in those not using antacids. Disease progression was the composite endpoint of death, an absolute FVC decrease of at least 10%, and a decrease of 50 meters or more in the 6-minute walk distance (6MWD). In both groups of patients, the rates of all-cause mortality were also similar.
The risk of death from IPF at 1 year also was not significantly different; 3.9% for antacid users and 5.2% for those not using antacids.
When patients were grouped on the basis of FVC at baseline – either less than 70% FVC or at least 70% FVC or greater – little or no difference was seen in disease mortality, disease progression, changes in FVC, 6MWD, and all-cause hospital admission between patients who received antacids and those who did not receive antacids at baseline.
Prior to stratification by baseline FVC, the rates of all-cause hospital admissions, gastrointestinal adverse effects, infections, and pulmonary infections were similar for the two groups of patients. At 52 weeks, however, infections and pulmonary infections were significantly higher in patients who received antacid therapy at baseline compared with those patients who did not receive antacids at baseline (74% vs. 62%; P = .0174 and 14% vs. 6%; P = .0214, respectively).
Unlike the patients in the previous retrospective studies, few patients in the placebo arms of the clinical trials had advanced IPF and low FVC, the researchers noted. All had IPF that had been diagnosed within 48 months of entering a trial, no evidence of improvement in disease severity in the year preceding trial entry, a predicted FVC of 50% or more, and a 6MWD of 150 meters or more. Among the patients receiving antacid therapy at baseline, 88% used proton-pump inhibitors, 8% used H2 blockers and 4% used proton-pump inhibitors and H2 blockers. Of the 291 patients receiving antacid therapy, 38 stopped after baseline; of the 333 not receiving antacid therapy, 83 started receiving the therapy after baseline.
Dr. Kreuter disclosed ties with Boehringer Ingelheim and InterMune/Roche. Two coauthors disclosed ties with F. Hoffmann-La Roche, which funded the study: Derek Weycker, Ph.D., reported receiving funding from the company, and Dr. Klaus-Uwe Kirchgaessler is an employee.
FROM THE LANCET RESPIRATORY MEDICINE
Key clinical point: Antacids don’t slow the progression of idiopathic pulmonary fibrosis.
Major finding: At 52 weeks, infections and pulmonary infections were significantly higher in patients who received antacid therapy at baseline compared with those patients who did not receive antacids at baseline (74% vs. 62%; P = .0174 and 14% vs. 6%; P = .0214, respectively).
Data source: IPF patients in the placebo groups in three large, phase III trials of pirfenidone; 291 patients were receiving antacid therapy and 333 patients were not receiving antacid therapy at baseline.
Disclosures: Dr. Kreuter disclosed ties with Boehringer Ingelheim and InterMune/Roche. Two coauthors disclosed ties with F. Hoffmann-La Roche, which funded the study: Derek Weycker, Ph.D., reported receiving funding from the company, and Dr. Klaus-Uwe Kirchgaessler is an employee.
Thousands of DNA modifications seen in infants of smoking mothers
The findings of a new, international study of 6,685 mothers and their newborns may explain why certain infant and child health problems frequently have been seen in the offspring of mothers who smoked during pregnancy, Kendall Morgan, Ph.D., wrote in the National Institutes of Health Director’s Blog.
The study, published in the American Journal of Human Genetics, “found significant differences between the epigenetic patterns of babies born to women who smoked during pregnancy and those born to nonsmokers, with many of the differences affecting genes known to play key roles in the development of the lungs, face, and nervous system,” Dr. Morgan wrote in the April 12 blog entry.
Smaller studies show there is evidence that maternal smoking can have epigenetic effects on a fetus. The new research from 13 research cohorts reaffirms and renders this finding more statistically powerful, Dr. Morgan wrote. In the infants of women who smoked every day during pregnancy, the researchers found more than 6,000 places where chemical marks on the DNA differed from those of babies born to mothers who did not smoke during pregnancy. The researchers also observed more than 4,600 epigenetic modifications in the DNA of babies of mothers who self-identified as falling under the broad category of having engaged in “any smoking during pregnancy.”
The genes thought to cause a cleft lip and/or palate were among the others to have been epigenetically modified in the fetuses of women who smoked while pregnant. The study also suggested that thousands of the epigenetic modifications seen affected children until at least age 4 years.
Read the study in the American Journal of Human Genetics (doi: 10.1016/j.ajhg.2016.02.019).
The findings of a new, international study of 6,685 mothers and their newborns may explain why certain infant and child health problems frequently have been seen in the offspring of mothers who smoked during pregnancy, Kendall Morgan, Ph.D., wrote in the National Institutes of Health Director’s Blog.
The study, published in the American Journal of Human Genetics, “found significant differences between the epigenetic patterns of babies born to women who smoked during pregnancy and those born to nonsmokers, with many of the differences affecting genes known to play key roles in the development of the lungs, face, and nervous system,” Dr. Morgan wrote in the April 12 blog entry.
Smaller studies show there is evidence that maternal smoking can have epigenetic effects on a fetus. The new research from 13 research cohorts reaffirms and renders this finding more statistically powerful, Dr. Morgan wrote. In the infants of women who smoked every day during pregnancy, the researchers found more than 6,000 places where chemical marks on the DNA differed from those of babies born to mothers who did not smoke during pregnancy. The researchers also observed more than 4,600 epigenetic modifications in the DNA of babies of mothers who self-identified as falling under the broad category of having engaged in “any smoking during pregnancy.”
The genes thought to cause a cleft lip and/or palate were among the others to have been epigenetically modified in the fetuses of women who smoked while pregnant. The study also suggested that thousands of the epigenetic modifications seen affected children until at least age 4 years.
Read the study in the American Journal of Human Genetics (doi: 10.1016/j.ajhg.2016.02.019).
The findings of a new, international study of 6,685 mothers and their newborns may explain why certain infant and child health problems frequently have been seen in the offspring of mothers who smoked during pregnancy, Kendall Morgan, Ph.D., wrote in the National Institutes of Health Director’s Blog.
The study, published in the American Journal of Human Genetics, “found significant differences between the epigenetic patterns of babies born to women who smoked during pregnancy and those born to nonsmokers, with many of the differences affecting genes known to play key roles in the development of the lungs, face, and nervous system,” Dr. Morgan wrote in the April 12 blog entry.
Smaller studies show there is evidence that maternal smoking can have epigenetic effects on a fetus. The new research from 13 research cohorts reaffirms and renders this finding more statistically powerful, Dr. Morgan wrote. In the infants of women who smoked every day during pregnancy, the researchers found more than 6,000 places where chemical marks on the DNA differed from those of babies born to mothers who did not smoke during pregnancy. The researchers also observed more than 4,600 epigenetic modifications in the DNA of babies of mothers who self-identified as falling under the broad category of having engaged in “any smoking during pregnancy.”
The genes thought to cause a cleft lip and/or palate were among the others to have been epigenetically modified in the fetuses of women who smoked while pregnant. The study also suggested that thousands of the epigenetic modifications seen affected children until at least age 4 years.
Read the study in the American Journal of Human Genetics (doi: 10.1016/j.ajhg.2016.02.019).
FROM THE AMERICAN JOURNAL OF HUMAN GENETICS
FDA grants priority review for additional use of atezolizumab
The Food and Drug Administration has granted priority review for atezolizumab for the treatment of people with locally advanced or metastatic non–small-cell lung cancer expressing the programmed death ligand–1 protein (PD-L1) who progressed on or after platinum-containing chemotherapy.
“In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine,” said Dr. Sandra Horning, chief medical officer and head of global product development for Roche and Genentech, in a press release. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit form atezolizumab alone.”
In February 2015, the FDA also granted the drug breakthrough therapy designation for the treatment of people with non–small-cell lung cancer expressing PD-L1 that progressed during or after standard treatments.
Earlier this year, the FDA granted a priority review of atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma, who had disease progression during or following platinum-based chemotherapy in the metastatic stetting or disease worsening within 12 months of receiving platinum-based chemotherapy before or after surgery.
The Food and Drug Administration has granted priority review for atezolizumab for the treatment of people with locally advanced or metastatic non–small-cell lung cancer expressing the programmed death ligand–1 protein (PD-L1) who progressed on or after platinum-containing chemotherapy.
“In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine,” said Dr. Sandra Horning, chief medical officer and head of global product development for Roche and Genentech, in a press release. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit form atezolizumab alone.”
In February 2015, the FDA also granted the drug breakthrough therapy designation for the treatment of people with non–small-cell lung cancer expressing PD-L1 that progressed during or after standard treatments.
Earlier this year, the FDA granted a priority review of atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma, who had disease progression during or following platinum-based chemotherapy in the metastatic stetting or disease worsening within 12 months of receiving platinum-based chemotherapy before or after surgery.
The Food and Drug Administration has granted priority review for atezolizumab for the treatment of people with locally advanced or metastatic non–small-cell lung cancer expressing the programmed death ligand–1 protein (PD-L1) who progressed on or after platinum-containing chemotherapy.
“In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine,” said Dr. Sandra Horning, chief medical officer and head of global product development for Roche and Genentech, in a press release. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit form atezolizumab alone.”
In February 2015, the FDA also granted the drug breakthrough therapy designation for the treatment of people with non–small-cell lung cancer expressing PD-L1 that progressed during or after standard treatments.
Earlier this year, the FDA granted a priority review of atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma, who had disease progression during or following platinum-based chemotherapy in the metastatic stetting or disease worsening within 12 months of receiving platinum-based chemotherapy before or after surgery.
Students’ hours of physical education fall short of national recommendations
Few states follow the national recommendations for weekly time in physical education at the elementary and middle school levels, and no state follows the recommended rate of physical education participation at the high school level, according to the 2016 update to the Shape of the Nation report.
The report, which is sponsored by Voices for Healthy Kids – a joint initiative of the American Heart Association and Robert Wood Johnson Foundation, and SHAPE, the Society of Health and Physical Educators – was formulated from responses of physical education coordinators in the 50 state education agencies and the District of Columbia to a questionnaire on kindergarten through 12th grade physical education and physical activity requirements. The education coordinators were queried during the winter of 2015-2016.
At the elementary school level, five states – Alabama, Florida, Louisiana, New Jersey, and Oregon – and the District of Columbia require students to participate in physical education for 150 minutes per week, the nationally recommended rate. For middle schoolers, the nationally recommended rate of participation in physical education is 225 minutes per week, which is followed in even fewer parts of the country; Montana, Oregon, and the District of Columbia are its sole adopters. California and Hawaii are the only two states who come close to satisfying the national recommendation of providing high school students with 225 minutes per week of physical education. In California, students in grades 7-12 receive 400 minutes of physical education per 10 school days and, in Hawaii, ninth graders receive 200 minutes of physical education per week.
While most states do not require their schools to follow the nationally recommended hours of weekly physical education for schools, the majority of states require students to participate in some amount of physical education during elementary school, middle school, and high school. State physical education requirements are undermined, though, by the majority of states offering ways for students to get out of participating in a physical education course, the report said. Specifically, more than 31 states allow students to substitute participating – in activities such as Junior Reserve Officer Training Corps, interscholastic sports, marching band, and cheerleading – with earning their required physical education credit. In addition, 15 states allow schools or school districts to apply for a waiver from the state physical education requirements, with “medical purposes” having been the most common reason for granting such an exemption.
“There is a large disparity in state requirements and implementation, affecting children’s ability to engage in and benefit from these [physical education] programs,” the report said. “Physical education improves student wellness and academic outcomes, develops life skills that shape the whole person, encourages smart choices, and cultivates a healthful lifestyle.”
The full report is available for download at www.shapeamerica.org/shapeofthenation.
Few states follow the national recommendations for weekly time in physical education at the elementary and middle school levels, and no state follows the recommended rate of physical education participation at the high school level, according to the 2016 update to the Shape of the Nation report.
The report, which is sponsored by Voices for Healthy Kids – a joint initiative of the American Heart Association and Robert Wood Johnson Foundation, and SHAPE, the Society of Health and Physical Educators – was formulated from responses of physical education coordinators in the 50 state education agencies and the District of Columbia to a questionnaire on kindergarten through 12th grade physical education and physical activity requirements. The education coordinators were queried during the winter of 2015-2016.
At the elementary school level, five states – Alabama, Florida, Louisiana, New Jersey, and Oregon – and the District of Columbia require students to participate in physical education for 150 minutes per week, the nationally recommended rate. For middle schoolers, the nationally recommended rate of participation in physical education is 225 minutes per week, which is followed in even fewer parts of the country; Montana, Oregon, and the District of Columbia are its sole adopters. California and Hawaii are the only two states who come close to satisfying the national recommendation of providing high school students with 225 minutes per week of physical education. In California, students in grades 7-12 receive 400 minutes of physical education per 10 school days and, in Hawaii, ninth graders receive 200 minutes of physical education per week.
While most states do not require their schools to follow the nationally recommended hours of weekly physical education for schools, the majority of states require students to participate in some amount of physical education during elementary school, middle school, and high school. State physical education requirements are undermined, though, by the majority of states offering ways for students to get out of participating in a physical education course, the report said. Specifically, more than 31 states allow students to substitute participating – in activities such as Junior Reserve Officer Training Corps, interscholastic sports, marching band, and cheerleading – with earning their required physical education credit. In addition, 15 states allow schools or school districts to apply for a waiver from the state physical education requirements, with “medical purposes” having been the most common reason for granting such an exemption.
“There is a large disparity in state requirements and implementation, affecting children’s ability to engage in and benefit from these [physical education] programs,” the report said. “Physical education improves student wellness and academic outcomes, develops life skills that shape the whole person, encourages smart choices, and cultivates a healthful lifestyle.”
The full report is available for download at www.shapeamerica.org/shapeofthenation.
Few states follow the national recommendations for weekly time in physical education at the elementary and middle school levels, and no state follows the recommended rate of physical education participation at the high school level, according to the 2016 update to the Shape of the Nation report.
The report, which is sponsored by Voices for Healthy Kids – a joint initiative of the American Heart Association and Robert Wood Johnson Foundation, and SHAPE, the Society of Health and Physical Educators – was formulated from responses of physical education coordinators in the 50 state education agencies and the District of Columbia to a questionnaire on kindergarten through 12th grade physical education and physical activity requirements. The education coordinators were queried during the winter of 2015-2016.
At the elementary school level, five states – Alabama, Florida, Louisiana, New Jersey, and Oregon – and the District of Columbia require students to participate in physical education for 150 minutes per week, the nationally recommended rate. For middle schoolers, the nationally recommended rate of participation in physical education is 225 minutes per week, which is followed in even fewer parts of the country; Montana, Oregon, and the District of Columbia are its sole adopters. California and Hawaii are the only two states who come close to satisfying the national recommendation of providing high school students with 225 minutes per week of physical education. In California, students in grades 7-12 receive 400 minutes of physical education per 10 school days and, in Hawaii, ninth graders receive 200 minutes of physical education per week.
While most states do not require their schools to follow the nationally recommended hours of weekly physical education for schools, the majority of states require students to participate in some amount of physical education during elementary school, middle school, and high school. State physical education requirements are undermined, though, by the majority of states offering ways for students to get out of participating in a physical education course, the report said. Specifically, more than 31 states allow students to substitute participating – in activities such as Junior Reserve Officer Training Corps, interscholastic sports, marching band, and cheerleading – with earning their required physical education credit. In addition, 15 states allow schools or school districts to apply for a waiver from the state physical education requirements, with “medical purposes” having been the most common reason for granting such an exemption.
“There is a large disparity in state requirements and implementation, affecting children’s ability to engage in and benefit from these [physical education] programs,” the report said. “Physical education improves student wellness and academic outcomes, develops life skills that shape the whole person, encourages smart choices, and cultivates a healthful lifestyle.”
The full report is available for download at www.shapeamerica.org/shapeofthenation.
FDA Requires Labeling Changes to Metformin-containing Drugs
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
FDA requires labeling changes to metformin-containing drugs
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function, according to the FDA’s recent review of several medical studies.
These findings have prompted the FDA to require manufacturers to change the labeling for metformin-containing drugs. These drugs’ labels now must include the results of the medical studies and new measures of kidney function for determining if a patient can use metformin, says a written statement from the FDA.
Metformin’s current labeling strongly recommends against its use in some patients with kidneys that do not work normally. The FDA is specifically requiring that new labels include the recommendation that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (that is, the glomerular filtration rate estimating equation, eGFR).
The full labeling recommendations are available in the FDA’s written statement.
Additional information including a data summary and a list of metformin-containing drugs is available in the FDA Drug Safety Communication.
The FDA asks that healthcare professionals and patients report adverse events or side effects related to the use of metformin-containing drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
FDA: CT scans safe for patients with electronic medical devices
There’s no need to let fear of electronic interference between computed tomography and electronic medical devices preclude the ordering of such scans for patients with insulin pumps, cardiac implantable electronic devices, or neurostimulators, the Food and Drug Administration said in a written notification.
“The probability of an adverse event being caused by exposing these devices to CT irradiation is extremely low, and it is greatly outweighed by the clinical benefit of a medically indicated CT examination,” according to the new notification, which updates and replaces a preliminary health notification released on July 14, 2008.
The preliminary notification said there was a “possibility that the x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction.” It also included recommendations to reduce the potential risk of such events from occurring and cited adverse events experienced by a few patients with medical devices who had undergone CT scanning, including unintended shocks from neurostimulators, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.
The new notification says there is an extremely low probability that a CT scanner directly irradiating the circuitry of certain implantable or wearable electronic medical devices can cause sufficient electronic interference to affect the function and operation of the medical device, and this probability is even lower when the radiation dose and the radiation dose rate are reduced. The FDA also notes that the interference is completely avoided when the medical device is outside of the primary x-ray beam of the CT scanner.
The update, which provides additional reports of adverse events by patients with electronic medical devices who had CT scans, states that the number of such events was small, compared with the number of patients with insulin pumps, cardiac implantable electronic devices, and neurostimulators who were scanned without adverse effects.
The FDA encourages health care providers and patients who suspect a problem with a medical imaging device to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
There’s no need to let fear of electronic interference between computed tomography and electronic medical devices preclude the ordering of such scans for patients with insulin pumps, cardiac implantable electronic devices, or neurostimulators, the Food and Drug Administration said in a written notification.
“The probability of an adverse event being caused by exposing these devices to CT irradiation is extremely low, and it is greatly outweighed by the clinical benefit of a medically indicated CT examination,” according to the new notification, which updates and replaces a preliminary health notification released on July 14, 2008.
The preliminary notification said there was a “possibility that the x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction.” It also included recommendations to reduce the potential risk of such events from occurring and cited adverse events experienced by a few patients with medical devices who had undergone CT scanning, including unintended shocks from neurostimulators, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.
The new notification says there is an extremely low probability that a CT scanner directly irradiating the circuitry of certain implantable or wearable electronic medical devices can cause sufficient electronic interference to affect the function and operation of the medical device, and this probability is even lower when the radiation dose and the radiation dose rate are reduced. The FDA also notes that the interference is completely avoided when the medical device is outside of the primary x-ray beam of the CT scanner.
The update, which provides additional reports of adverse events by patients with electronic medical devices who had CT scans, states that the number of such events was small, compared with the number of patients with insulin pumps, cardiac implantable electronic devices, and neurostimulators who were scanned without adverse effects.
The FDA encourages health care providers and patients who suspect a problem with a medical imaging device to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
There’s no need to let fear of electronic interference between computed tomography and electronic medical devices preclude the ordering of such scans for patients with insulin pumps, cardiac implantable electronic devices, or neurostimulators, the Food and Drug Administration said in a written notification.
“The probability of an adverse event being caused by exposing these devices to CT irradiation is extremely low, and it is greatly outweighed by the clinical benefit of a medically indicated CT examination,” according to the new notification, which updates and replaces a preliminary health notification released on July 14, 2008.
The preliminary notification said there was a “possibility that the x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction.” It also included recommendations to reduce the potential risk of such events from occurring and cited adverse events experienced by a few patients with medical devices who had undergone CT scanning, including unintended shocks from neurostimulators, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.
The new notification says there is an extremely low probability that a CT scanner directly irradiating the circuitry of certain implantable or wearable electronic medical devices can cause sufficient electronic interference to affect the function and operation of the medical device, and this probability is even lower when the radiation dose and the radiation dose rate are reduced. The FDA also notes that the interference is completely avoided when the medical device is outside of the primary x-ray beam of the CT scanner.
The update, which provides additional reports of adverse events by patients with electronic medical devices who had CT scans, states that the number of such events was small, compared with the number of patients with insulin pumps, cardiac implantable electronic devices, and neurostimulators who were scanned without adverse effects.
The FDA encourages health care providers and patients who suspect a problem with a medical imaging device to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
Drug for conditioning AML patients for transplant gets orphan drug designation
A radioimmunotherapeutic drug for conditioning relapsed and refractory acute myeloid leukemia (AML) patients for a hematopoietic stem cell transplant has been granted orphan drug designation by the Food and Drug Administration.
Iomab-B is a radioimmunoconjugate consisting of the murine monoclonal antibody BC8 and an iodine-131 radioisotope. The Fred Hutchinson Cancer Research Center developed BC8 to target CD45, a panleukocytic antigen widely expressed on white blood cells. “When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues,” says a statement from Actinium Pharmaceuticals, which would market the drug.
Iomab-B will be tested in a multicenter trial that will include 150 patients over age 55 with refractory and relapsed AML. “There has not been a new drug approved for relapsed and refractory AML patients over the age of 55 in decades and with Iomab-B being the only therapy of its kind, we are pleased to have achieved this important milestone,” Sandesh Seth, executive chairman of Actinium, said in the statement.
A radioimmunotherapeutic drug for conditioning relapsed and refractory acute myeloid leukemia (AML) patients for a hematopoietic stem cell transplant has been granted orphan drug designation by the Food and Drug Administration.
Iomab-B is a radioimmunoconjugate consisting of the murine monoclonal antibody BC8 and an iodine-131 radioisotope. The Fred Hutchinson Cancer Research Center developed BC8 to target CD45, a panleukocytic antigen widely expressed on white blood cells. “When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues,” says a statement from Actinium Pharmaceuticals, which would market the drug.
Iomab-B will be tested in a multicenter trial that will include 150 patients over age 55 with refractory and relapsed AML. “There has not been a new drug approved for relapsed and refractory AML patients over the age of 55 in decades and with Iomab-B being the only therapy of its kind, we are pleased to have achieved this important milestone,” Sandesh Seth, executive chairman of Actinium, said in the statement.
A radioimmunotherapeutic drug for conditioning relapsed and refractory acute myeloid leukemia (AML) patients for a hematopoietic stem cell transplant has been granted orphan drug designation by the Food and Drug Administration.
Iomab-B is a radioimmunoconjugate consisting of the murine monoclonal antibody BC8 and an iodine-131 radioisotope. The Fred Hutchinson Cancer Research Center developed BC8 to target CD45, a panleukocytic antigen widely expressed on white blood cells. “When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues,” says a statement from Actinium Pharmaceuticals, which would market the drug.
Iomab-B will be tested in a multicenter trial that will include 150 patients over age 55 with refractory and relapsed AML. “There has not been a new drug approved for relapsed and refractory AML patients over the age of 55 in decades and with Iomab-B being the only therapy of its kind, we are pleased to have achieved this important milestone,” Sandesh Seth, executive chairman of Actinium, said in the statement.
New drug approved for hepatic veno-occlusive disease
Defibrotide sodium has been approved to treat hepatic veno-occlusive disease (VOD) in patients with renal or pulmonary dysfunction following a hematopoietic stem cell transplantation, the Food and Drug Administration has announced.
The drug, which will be marketed as Defitelio by Jazz Pharmaceuticals, was tested in two prospective clinical trials and an expanded access study that included a total of 528 patients with hepatic VOD and multiorgan dysfunction following a transplantation. All patients received 6.25 mg/kg doses of the drug intravenously, every 6 hours until resolution of VOD. The percentages of patients surviving more than 100 days after receiving a stem cell transplantation in each of the studies were 38%, 44%, and 45%, respectively, according to a statement from the FDA.
Contraindications for taking the drug are concurrent use of anticoagulants or fibrinolytic therapies.
Hypotension, diarrhea, vomiting, nausea, and epistaxis are the most common adverse reactions to the drug.
Full prescribing information is available at the FDA website.
Defibrotide sodium has been approved to treat hepatic veno-occlusive disease (VOD) in patients with renal or pulmonary dysfunction following a hematopoietic stem cell transplantation, the Food and Drug Administration has announced.
The drug, which will be marketed as Defitelio by Jazz Pharmaceuticals, was tested in two prospective clinical trials and an expanded access study that included a total of 528 patients with hepatic VOD and multiorgan dysfunction following a transplantation. All patients received 6.25 mg/kg doses of the drug intravenously, every 6 hours until resolution of VOD. The percentages of patients surviving more than 100 days after receiving a stem cell transplantation in each of the studies were 38%, 44%, and 45%, respectively, according to a statement from the FDA.
Contraindications for taking the drug are concurrent use of anticoagulants or fibrinolytic therapies.
Hypotension, diarrhea, vomiting, nausea, and epistaxis are the most common adverse reactions to the drug.
Full prescribing information is available at the FDA website.
Defibrotide sodium has been approved to treat hepatic veno-occlusive disease (VOD) in patients with renal or pulmonary dysfunction following a hematopoietic stem cell transplantation, the Food and Drug Administration has announced.
The drug, which will be marketed as Defitelio by Jazz Pharmaceuticals, was tested in two prospective clinical trials and an expanded access study that included a total of 528 patients with hepatic VOD and multiorgan dysfunction following a transplantation. All patients received 6.25 mg/kg doses of the drug intravenously, every 6 hours until resolution of VOD. The percentages of patients surviving more than 100 days after receiving a stem cell transplantation in each of the studies were 38%, 44%, and 45%, respectively, according to a statement from the FDA.
Contraindications for taking the drug are concurrent use of anticoagulants or fibrinolytic therapies.
Hypotension, diarrhea, vomiting, nausea, and epistaxis are the most common adverse reactions to the drug.
Full prescribing information is available at the FDA website.
FDA approves reslizumab as add-on drug for adults with severe asthma
The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.
The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.
In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.
The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.
Teva Pharmaceuticals is marketing the drug as Cinqair.
The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.
The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.
In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.
The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.
Teva Pharmaceuticals is marketing the drug as Cinqair.
The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.
The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.
In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.
The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.
Teva Pharmaceuticals is marketing the drug as Cinqair.
