A major study of the GlaxoSmithKline diabetes drug Avandia "was associated with an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI (Acute Myocardial Infarction), stroke, heart failure, or all-cause mortality in patients 65 years or older."
The researchers led by David J. Graham of the U.S. Food and Drug Administration examined data on 227,571 Medicare beneficiaries who took Avandia - also known as rosiglitazone - or a rival type 2 diabetes drug pioglitazone sold as Actos.
Those taking Avandia were 25 percent more likely to develop heart failure, 27 percent more likely to suffer a stroke, and 14 percent more likely to die from any cause. A story on the study and upcoming hearing is available here.
The study published in the Journal of the American Medical Association is the latest blow to GSK's drug, which has been under a cloud since 2007 when a review of multiple studies suggested it increased the risk of cardiovascular events such as stroke and death.
Earlier this month, Avandia was at the top of an FDA list of drugs linked to fatal adverse events in 2009, according to an analysis of U.S. Food and Drug Administration records by Horsham, Pa.-based Institute for Safe Medication Practices. GSK has defended the safety of Avandia and it has remained on the market in the U.S.
The ISMP analysis of reports linked Avandia to 1,354 adverse drug events. At the time the nonprofit said "GlaxoSmithKline told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company."
For the full ISMP report click here.
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