Today an article published in the Journal of the American Medical Association cites a new study out of Canada that suggests a significantly elevated risk of heart attack in patients treated by Avandia. The study was a retrospective analysis of medical records of over 159,000 patients age 65 and older. GlaxoSmithKline claims that the study is flawed and maintains that Avandia is safe. The controversy around Avandia has been building since a New England Journal of Medicine article published in May linked the popular type-2 diabetes medication to 42 percent increased risk of heart attack.
The lead author of the study Dr. Lorraine Lipscombe says that the study implies that atleast for those in the high-risk population the dangers of Avandia may outweigh the benefits.
The study results concluded that of those that were included in the study those treated with Avandia showed a 60 percent increased risk of heart failure, 40 percent elevated risk of heart attack and a 30 percent increased risk of death.
The F.D.A. released a statement Tuesday. “This new study we have just seen today does not change FDA’s recommendations,” the statement said, in part. “The information FDA provided for the most recent labeling change remains accurate — the data are inconclusive and we have added a boxed warning to the labeling to ensure that health care professionals and patients are aware of this potential risk and can take this into account as they make individual prescribing decisions.”
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.