FDA keeps GSK diabetes drug on market but restricts its use
Posted September 23, 2010
Research Triangle Park, N.C. — European health regulators have banned sales of the once-blockbuster diabetes drug Avandia because of evidence it raises the risk of heart attack, but doctors in the U.S. will be able to continue prescribing it with some significant restrictions.
In simultaneous news briefings, the European Medicines Agency and the U.S. Food and Drug Administration announced their decisions on the controversial drug. The European regulator said it would stop authorizing marketing of Avandia and said it would be removed from the market within the next few months.
Earlier this month, Britain’s drug regulator said an independent panel of experts concluded Avandia raised the risk of heart attacks and recommended it be pulled from the market.
GlaxoSmithKline (NYSE: GSK), which employs more than 4,000 people in the RTP area, has been under growing criticism for Avandia, which is used to treat Type 2 diabetes.
The FDA announced that new patients will be able to get a prescription for Avandia only if they can’t control their blood sugar with other medications. Doctors will have to document that their patients are eligible to receive the drug and have been briefed on its risks. FDA expects the restriction plan “will limit use of Avandia significantly.”
The FDA’s decision marks the second time in three years that the agency has decided to leave Avandia on the market, despite mounting pressure to recall the drug from outside medical experts, politicians and some of its own scientists.
The FDA first approved the drug in 1999 and it became the top-selling diabetes pill in the world. But use has plummeted since a 2007 analysis linked the drug to heart attack risks.
FDA’s critics have framed the Avandia decision as a key test of the agency’s Obama-appointed leadership, who vowed to bolster the agency’s regulatory stance after a series of drug safety problems under the previous administration.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret Hamburg, “We are seeking to strike the right balance to support clinical care.”
The FDA’s latest decision on Avandia is likely to draw ire from safety advocates and lawmakers on Capitol Hill, though it essentially concurs with the opinion outside experts reached earlier this year.
In July, a 33-member panel of medical experts voted 20-12 to keep Avandia available in the U.S. Of the 20 who voted to keep it on the market, 10 said it should only be available on a limited basis. The FDA is not required to follow the group’s advice, though it often does.