Avandia to be pulled from retail pharmacy shelves
In September 2010, the Food and Drug Administration (FDA) announced it would restrict access to Avandia (rosiglitazone)--one of the leading forms of treatment for patients with Type 2 diabetes. Manufactured by GlaxoSmithKline (GSK), Avandia was designed, in combination with diet and exercise--to improve glucose control for individuals with Type 2 diabetes.
In 2007, a study conducted by Dr. Steven Nissen of the Cleveland Clinic discovered the drug could increase the risk of heart attacks. More recent studies have also concluded the use of Avandia can lead to elevated risks of cardiovascular events, including strokes, heart attacks and more. Since that time, there has been a multi-year Senate investigation and a loud public debate between GlaxoSmithKline (GSK)--the maker of the drug--Dr. Kissen, the FDA and lawmakers.
Limiting access to Avandia
The September 2010 restrictions announced by the FDA included several key points, including the need for GSK to design a "restricted access program." Under that policy, only the following individuals could have access to Avandia:
- New patients unable to control their glucose effectively with other medications
- Current users experiencing benefits that choose to continue using Avandia
Additionally, doctors were supposed to document patient eligibility, and patients were required to review the cardiovascular risks associated with Avandia and acknowledge they understood those risks. In a press release, Janet Woodcock, MD, the director of the FDA's Center for Drug Evaluation and Research noted, "Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug."
FDA puts restrictions in place
Eight months after announcing the initial restrictions on Avandia, the FDA revealed on May 18 it is putting complete restrictions in place--pulling the drug from pharmacy shelves beginning on November 18. Says Dr. Nissen in an interview with USA Today, "It's like a decade-long nightmare coming to an end. Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it."
In additions to the restrictions announced in September, additional restrictions will be put into place, including the following:
- Health care providers must be certified through the Avandia-Rosiglitazone Medicines Access Program to prescribe the drug
- Patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program to receive prescriptions
- The medication will only be available by mail order from certified pharmarcies that participate in the program
On the market since 1999, Avandia has been widely prescribed. In 2006, Avandia's sales surpassed $3.2 billion and $1.19 billion as recently as 2009. However, in 2010, GSK wrote off a $2.3 billion charge in liabilities related to various legal cases surrounding Avandia and another popular GSK drug, Paxil.
FDA, "Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl"
USA Today, "Diabetes drug Avandia to be pulled from retail shelves"