In order for Americans to continue to receive the drug, their doctors must attest to and document their patients’ eligibility. Patients will also have to review statements describing the cardiovascular safety concerns associated with Avandia and acknowledge they understand the risks. The FDA says it anticipates the tight restrictions will likely have a devastating impact on GlaxoSmithKline’s (GSK) Avandia, the sales of which topped $2 billion last year, down from $3.2 billion in 2006.

Avandia, known by the generic rosiglitazone, is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve blood sugar control in patients with Type 2 diabetes mellitus. Rosiglitazone is also available in combination with other diabetes medications, such as metformin under the brand name Avandament or glimepiride under the name Avandaryl.

Despite studies that suggest as many as 100,000 heart attacks may have been caused by Avandia, GSK has long insisted that its billion-dollar drug is safe, going so far as to hold its own study comparing Avandia with a similar medication, Actos. The FDA has ordered GSK to end the study.

The FDA also ordered GSK to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. During a review of the data, the FDA questioned GSK’s potential bias in the identification of cardiovascular events.

The FDA is continuing to review complaints on the medication. Any side effects with Avandia, or any other medication, should be reported to the FDA Medwatch Adverse Event Reporting Program at www.FDA.gov/Medwatch.

Sources:
New York Times
FDA

SOURCE: Avandia Recall › FDA puts tight restrictions on Avandia due to heart attack, stroke risk

Avandia was approved by the FDA for the treatment of Type 2 diabetes in 1999, and grew to become a $3 billion a year industry for GSK. In 2007, a study was published in the New England Journal of Medicine that linked Advandia to a 43 percent increased risk of heart disease. The senators contend that the London-based GSK got its hands on a copy of the report before it was published and the drug company quickly initiated a public relations push to counter any questions about Avandia’s link to increased heart risk. The drug company also urged the medical researchers who identified the risk of heart and liver problems in patients taking Avandia to stop publishing their findings.

The effort kept the drug on the market, but GSK took a near-$2 billion hit in sales in 2009. A company spokeswoman said in a statement, “the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events … Based on the scientific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes.”

Senators Baucus and Crassley disagree. “It can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns,” wrote Baucus and Grassley in the Senate committee report. “Instead, GlaxoSmithKline executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

Sources:
Business Week
New York Times

SOURCE: Avandia Recall › Senators ask why dangerous Avandia was not pulled from market