GlaxoSmithKline Plc (GSK)’s diabetes drug Avandia will be pulled from U.S. pharmacies in November and available only through a special program, the Food and Drug Administration said.
The restrictions are part of a risk mitigation strategy established in September with a medication guide to limit the use of Avandia after data suggested patients had a higher chance of heart attacks. The drug and combination therapies containing it will no longer be available in retail pharmacies starting Nov. 18, according to the FDA, which is requiring doctors and patients to enroll in a program to prescribe or take them.
Avandia, once the world’s best-selling diabetes bill at $3 billion in annual revenue, generated $680 million in sales last year for London-based Glaxo. About 460,500 patients filled a prescription for Avandia, Avandamet or Avandaryl at a retail pharmacy from January to October 2010, the FDA said in a safety announcement posted today on its website.
“Healthcare providers and patients must be enrolled in the Avandia-rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines,” the agency said, using the chemical name for the drug. Patients will receive their medicines through specially certified mail order pharmacies, the agency said.
Wednesday, May 18, 2011
Glaxo’s Diabetes Drug Avandia Pulled From U.S. Pharmacies - Bloomberg
via bloomberg.com
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Avandia was approved for marketing by the FDA on May 25, 1999, and was cleared only 6 months after GlaxoSmithKline's predecessor submitted its New Drug Application. At the time, the assigned medical officer expressed concern about the premarket studies and wanted to include warnings about EKG changes and chest pain. This recommendation was ignored by the FDA brass.
In the fall of 1999, the manufacturer secretly began a study comparing its drug with a competitor, Actos, and found that Avandia was no more effective than Actos and had a greater risk of heart problems. A March 29, 2001 e-mail from a company exec states, "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK."
This is just the tip of the iceberg of what went on with Avandia and what goes on in the drug industry. The truth is that what is scheduled to take place next November is how the drug should have been introduced in June 1999, when it entered the market. But then, GSK would not have received the billions of dollars in sales over the intervening decade plus – and tens of thousands of Americans would not have suffered heart attacks and deaths.
The FDA is broken and needs a major repair job. For those in agreement I would urge you to go to www.FDAReformPetition.com and sign up. Congress needs to hear our complaint.
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