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.
Share Tools
Top News Headlines
- Outrage grows over Syria killings
- Syrian authorities have blocked a top aide of envoy Kofi Annan from heading to Damascus as world leaders condemn one of the bloodiest single events in Syria's 14-month-old uprising. more »
- Montreal protesters march in peaceful defiance
- The clanging of pots and pans sounded throughout Montreal's downtown core Saturday night and into early Sunday morning, as thousands of protesters marched on in peaceful — but loud — defiance of Bill 78. more »
- Quebec actress captures Cannes prize
- Canadian Suzanne Clement has been awarded the Best Actress prize in the Cannes Film Festival's sidebar competition, Un Certain Regard. more »
- Lady Gaga nixes Indonesia show after threats
- Lady Gaga cancelled her sold-out show in Indonesia after Islamist hard-liners threatened violence, claiming her sexy clothes and provocative dance moves would corrupt the youth. more »
- Teen struck by lightning in Ottawa dies
- Missing Winnipeg children found in Mexico
- Quebec tornadoes cause millions in damage
- Montreal protesters march in peaceful defiance
- Woman's remains found in hockey bag on Cape Breton river
- Outrage grows over Syria killings
- Pope's butler arrested in Vatican leaks scandal
- Everest team unable to bring down Toronto woman's body
- WWE apologizes to Brazil over Canadian's flag stomp
