Use of Avandia restricted by FDA

WASHINGTON — The Food and Drug Administration and drug regulators in Europe have restricted the sale of Avandia, the controversial diabetes medicine marketed by Glaxo­Smith­Kline PLC (GSK) that has been linked to significant heart risks.

The drug’s sales are being suspended entirely in Europe, while patients in the United States will be allowed access to the medicine only if they and their doctors attest that they have tried every other diabetes medication and that patients have been made aware of the drug’s risks to the heart. Patients now taking Avandia may continue to do so.

Dr. Steven Nissen, a Cleveland Clinic cardiologist whose studies highlighted Avandia’s heart attack risks, said that the decision culminated “one of the worst drug safety tragedies in our lifetime.”

The restrictions imposed by the U.S. and European governmental bodies are likely to ensure that Avandia’s sales — an estimated $1.19 billion last year versus $3.2 billion as recently as 2006 — will plunge as regulatory authorities around the world are bound to follow with similar restrictions.

Avandia was once the biggest-selling diabetes drug in the world, but concerns about itsheart attack risks have already cut the product’s sales. About 600,000 people currently take Avandia in the United States, according to FDA commissioner Margaret Hamburg.

GSK says that “the company continues to believe that Avandia is an important treatment for patients with type 2 diabetes” and that it is working with the FDA and European regulators “to implement the required actions.”

The company vowed to end Avandia promotions worldwide.

Still, the restrictions are expected to take months to put in place. Patients now taking Avandia should continue to do so until they can consult their doctors, said Dr. Joshua Sharf­stein, the FDA’s principal deputy commissioner. But he added that physicians should now consider switching patients to other medicines.