Diabetes drug should be pulled over heart risks, FDA scientist says
Last Updated: Monday, July 30, 2007 | 10:23 AM ET
The Associated Press
A U.S. federal scientist says the widely used diabetes drug Avandia should be pulled from the market because of heart risks.
The opinion of Dr. David Graham, a U.S. Food and Drug Administration scientist, is contained in a slide presentation among documents distributed at the start of a day-long meeting of experts in Washington.
Graham argues that the heart risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market.
GlaxoSmithKline officials, meanwhile, are disputing that conclusion. Respresentatives of the drug company are making their case later Monday at the meeting of a joint panel of outside experts.
The meeting was convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings, or removed altogether from sale.
The FDA isn't required to follow the advice of its advisory committees, but usually does.
Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.
The FDA has moved up the date of the 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 per cent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication.
Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared to other diabetes drugs, including Actos.
Health Canada approved Avandia for use in patients when diet, weight loss and exercise fail to control diabetes.
