Government health advisers are being asked Monday to consider whether heart risks associated with the widely used diabetes drug Avandia outweigh its benefits in helping some or all patients.
Information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack, Food and Drug Administration reviewers said. The regulatory agency is seeking advice from a joint panel of outside experts on whether the drug should be pulled from the market or restricted to use in select patients and branded with prominent warnings. It isn't required to follow the advice of its advisory committees but usually does.
The FDA moved up the date of Monday's meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia's safety. The pooled analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.
Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs.
About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia, also called rosiglitazone, might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.
On the Net:
Food and Drug Administration: http://www.fda.gov/