The FDA on Sept. 23 severely restricted the use of the controversial diabetes drug, Avandia, made by British firm GlaxoSmithKline, but stopped short of an outright ban. The Food and Drug Administration said it was taking the step after data suggested "an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia."
Under the restrictions, the one-time blockbuster medicine will now only be available to new U.S. patients with type 2 diabetes if they are unable to control their glucose levels through other medications. Existing diabetes sufferers taking Avandia will be allowed to continue to take the medicine if they so choose, the FDA statement said.
"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 US move came as the EU regulator, the European Medicines Agency, said the drug would no longer be available to patients in Europe, after recommending it be removed from the market.
A majority of members of a key FDA advisory had recommended in July that the government should allow Avandia to stay on the market in the United States but with greater restrictions on its sale.
Avandia, which generated some $1.2 billion in 2009 for Britain's largest pharmaceutical firm, has long been associated with an increased risk of heart attack and stroke. An FDA study linking the medication to serious health concerns prompted authorities to slap a warning on it in 2007.
"Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug," said Janet Woodcock director of the FDA's Center for Drug Evaluation and Research.
Doctors will now have to attest that their patients are eligible to be prescribed Avandia, and the patients will have to acknowledge that they are aware of the risks.
The FDA said it would require Glaxo to develop a restricted access program for Avandia under a risk evaluation and mitigation strategy. It also ordered the company to set up an independent group of scientists to review the company's clinical trials on the cardiovascular safety of Avandia compared to standard diabetes drugs. It warned further action may follow once the review has been completed.
And the US watchdog halted Glaxo's clinical trial comparing Avandia to the other most popular diabetes drug Actos as well as standard diabetes medication.
Avandia, also known by its generic name Rosiglitazone, is additionally available in combination with other diabetes drugs, such as metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.
Copyright Agence France-Presse, 2010
