Avandia withdrawal from shelves by November: FDA

By Dr. Ananya Mandal, MDMay 22 2011

The Food and Drugs Administration (FDA) has announced that in the beginning of November, the diabetes drug Avandia will no longer be sold in pharmacy shelves, due to the cardiovascular risks it’s causing its patients.

Type 2 Diabetes affects about 23 million Americans, and is caused by a problem that in the body makes or uses insulin. Insulin is used to move the blood sugar into the cells. Avandia from GlaxoSmithKline Plc (GSK) is one of the newest drugs to be taken orally for blood sugar control.

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. The rules state that the drug will only be available to patients that have been taking the medicine safely, and to those who can’t control their blood sugars with another drug and to those who know the risks of Avandia and still choose to take it. This, according to the agency means that the patients will have to enroll in a special program to qualify for the drug.

As part of restrictions by the FDA last September, doctors have had to state and document a patient’s eligibility to use Avandia, they also have to let patients know of the risks that could come with using Avandia and patients have to acknowledge that they understand.

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. Use of the medication has fallen by half during the year, with 235,500 patients filling a prescription in January and 119,000 getting the drugs in October, the agency said.

“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.

GSK on its part would start informing pharmacists and physicians about the new program within the 60 day window allowed by the FDA, and implement the changes at or before that time, said Mary Anne Rhyne, a company spokeswoman. Patients shouldn’t abruptly stop taking their diabetes medicines without first discussing it with their doctors, she said.