FDA Alert: The controversial diabetes drug Avandia will be pulled from pharmacy shelves in November 2011 due to overwhelming evidence of the cardiovascular risks it poses to users. The move comes eight months after the FDA severely restricted the use of rosiglitazone – the active ingredient in Avandia – to diabetes patients for whom other medications do not work. Under the new regulations, Avandia will be so severely restricted that virtually no one will be able to get it.
What’s the problem?
May 19, 2011 – The U.S. Food & Drug Administration (FDA) announced today that GSK’s best-selling diabetes drug Avandia will no longer be available at retail pharmacies beginning on November 18th of this year. The new restrictions were implemented by the administration after compelling new data highlighted the severe cardiovascular risks it poses to diabetic patients.
Under the enhanced restrictions, medications containing rosiglitazone (Avandia, Avandamet, Avandaryl) will only be prescribed to individuals who have had no success with other diabetes medications, and to those who have been informed of the risk of side effects but still choose to take the drug. Qualified patients must then enroll in a special program to receive the drug.
“Under the Avandia-Rosiglitazone Medicines Access Program, rosiglitazone medicines will only be available to enrolled patients by mail order from certified pharmacies participating in the program,” the agency said in a statement released Wednesday. “The drug manufacturer, GlaxoSmithKline, will withdraw rosiglitazone medicines from the current supply chain and will provide pharmacies with instructions on returning the medicines.”
The new action comes less than a year after the FDA restricted the use of Avandia to those patients with type-II diabetes for whom other drugs do not work.
In November 2007, the FDA ordered that new information be added to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks. Then in September 2010, the FDA determined that the 2007 black box warning was not enough and issued stronger warnings and restricted use on Avandia. Additionally, the FDA ordered GSK to develop a risk evaluation and mitigation strategy (REMS) to make sure the drug is adequately restricted.
Avandia Side Effects
The side effects a patient may experience depends on a number of factors, including a person’s overall health and medical history. Avandia has been linked to the following severe side effects:
- congestive heart failure
- heart attack
- vision loss
- macular edema
- bone fractures
Avandia Background Information
Avandia is a thiazolidinedione (TZD) oral anti-diabetic drug that was first released into the market in 1999. Early on, Avandia showed great promise in the treatment of insulin resistance, and preliminary research indicated that it might be able to rescue failing beta cells. Unfortunately, over time Avandia was found to cause life-threatening side effects, the risk of which was far greater than the benefit it provided.
These adverse events have prompted scores of Avandia patients to file lawsuits against Glaxo in recent months. The pharmaceutical giant could face up to $6 billion in liability for side effects litigation in the near future. GSK has been suspected of covering up data about the link between Avandia and heart issues. In 2010, a Senate Finance Committee press release revealed that GSK had “attempted to downplay scientific findings about the safety of Avandia as far back as 2000.”