The U.S. Food and Drug Administration (FDA) announced Wednesday (May 18, 2011) that beginning November 18, 2011, GlaxoSmithKline’s best-selling, popular diabetes pill Avandia, will no longer be available at pharmacies due to the drug’s link to increased risks of heart attack and stroke. This latest FDA announcement comes after nearly a decade of controversy surrounding the drug’s serious cardiovascular risks to consumers. To review the FDA’s Drug Safety Communication, click here.
According to the new restrictions, after November 18, 2011 rosiglitazone-containing medications – such as Avandia, Avandament and Avandaryl will only be available through a special enrollment program known as the “Avandia-Rosiglitazone Medicines Access Program.” This new program will make these drugs available on a limited use basis to patients who have been safely using the drug, have had no success in controlling their blood sugar with other diabetes medications, and have been informed of the risks and still choose to take Avandia or other rosiglitazone containing drugs. Patients will receive their medicines through specialty certified mail order pharmacies participating in the program.
For years, research has suggested that people with type 2 diabetes taking the drug Avandia has a higher risk of heart attack or stroke by nearly 40%. With more than 23 million Americans thought to have diabetes, statistics reveal that close to a half-million Americans filled a prescription for a rosiglitazone-containing medication in the first 10 months of 2010. Advocates for restricting the use of Avandia are pleased with the FDA’s announcement, but wish it had come much sooner.
The FDA’s most recent announcement comes just 8 months after FDA began enforcing stringent restrictions on the use of Avandia. In January, GlaxoSmithKline announced that its legal charges for the fourth quarter of 2010 added up to $3.5 billion due to a slew of product liability suits against the pharmaceutical giant. The company is currently facing thousands of pending federal and state actions nationwide over its alleged failure to warn consumers about Avandia’s potential heart attack and stroke risks.
Patients or loved ones currently taking Avandia or other rosiglitazone containing medication should contact their healthcare provider as soon as possible, to determine if they should continue taking Avandia.
To read more about the FDA’s latest restriction on Avandia, click on related articles in Forbes, the Los Angeles Times, and Bloomberg.
Disclaimer: All use of the Avandia mark is for informational and product identification purposes only. This post should not be taken as either medical or legal advice, but instead should act as a resource in providing general information that may be useful to the general public. Pope McGlamry is not affiliated with the manufacturer of Avandia, GlaxoSmithKline, or its distributors.
