On Thursday, the U.S. and Europe both issued rulings on Avandia, the popular diabetes drug manufactured by GlaxoSmithKline, with the U.S. restricting its use and an EU agency recommending a full ban on the drug. The drug has met with increased scrutiny because of data that has suggested an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
The U.S. Food and Drug Administration announced that it will severely restrict the use of Avandia (generic name rosiglitazone): Patients with Type 2 diabetes already taking Avandia can continue using it if no other medications suffice, but their doctors will have to review the latest information about the drug’s risks and document the decision.
The new rules, expected to take effect over several months, will also apply to combination drugs containing rosiglitazone, including Avandamet, which contains metformin, and Avandaryl, which contains glimepiride.
The agency said it is also putting the brakes on a major study, called TIDE, that directly compares the efficacy of Avandia and competing drug Actos in controlling blood sugar.
The European Medicines Agency went further with its recommendations. The agency advised that rosiglitazone (brand name Avandia) and all medications containing the drug be taken off the market. The agency’s decision will now be passed to the European Commission, which is likely to take the agency’s advice.
About 600,000 Americans are currently taking Avandia. Dr. Steven Nissen, the Cleveland cardiologist who became the drug’s most well-known critic, said that, while it is important for patients on Avandia to continue on the drug until consulting their physicians, he predicts that more than 99 percent of Avandia use in the U.S. will disappear in the coming months.
“[With the restrictions in place, the FDA] essentially will remove the drug from the market,” Nissen said. “In order to use the drug physicians will have to have tried every other drug.”
The FDA stands behind its decision to keep Avandia available for consumers.
“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, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release.
For more on Avandia, see Need to Know’s previous coverage: