The Food and Drug Administration announced Thursday that it has decided to “significantly restrict” the use of rosiglitazone, the GlaxoSmithKline diabetes drug sold under the brand name Avandia.
The FDA said Avandia would be available only to “patients who cannot control their diabetes on other medications” because of data suggesting that the drug increases the risk of heart attacks, heart failure, stroke and other cardiovascular events.
While a blow to Glaxo, which has major operations and thousands of employees in the Philadelphia region, the European Medicines Agency took the more drastic step of ordering the drug and other two other medications that contain rosiglitazone (Avandamet and Avaglim) off the market in Europe.
“These medications will stop being available in Europe within the next few months,” the European drug agency said. “Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments.”
The European agency said its “suspension” of Avandia and the other medications would stay in place unless Glaxo “can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.”
In a statement, Glaxo acknowledged the regulatory actions in the US and Europe and added, “the company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions.”
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