GlaxoSmithKline (GSK) manufactures rosiglitazone maleate and markets it under three brand names: Avandia, which contains only rosiglitazone maleate; Avandamet, which also contains metformin hydrochloride (a diabetes drug in the biguanide class); and Avandaryl, which also contains glimepiride (a sulfonylurea). The safety issues addressed by the FDA apply to all three of these medicines.
Avandia, or rosiglitazone maleate, belongs to a class of medicines known as thiazolidinediones. Avandia, which was approved for sale in the United States by the U.S. Food and Drug Administration in May 1999, is used to treat type II diabetes by increasing the body's sensitivity to insulin in conjunction with diet and exercise.
Information About Avandia
FDA Concerns: Early 2007
On May 21, 2007, the FDA issued a bulletin that described the potential risks of Avandia related to "ischemic cardiovascular events in patients taking rosiglitazone based on safety data from controlled clinical trials." According to the FDA, other data did not necessarily support these conclusions, and, as a result, the FDA called a meeting on July 30, 2007, at which the available data were to be evaluated and discussed.
2007 Label Changes for Avandia
On August 14, 2007, the FDA approved a new label intended to address the concerns raised over potential problems with Avandia. This label included a "boxed warning," which is literally a warning surrounded by a box that appears at the beginning of a drug's official label, to the effect that Avandia was generally contraindicated in patients with serious heart problems. On November 14, 2007, the FDA approved the addition of a contraindication for patients with myocardial ischemia, or reduced blood flow to the heart, to the boxed warning.
February 2010 FDA Announcement Regarding New Study Data
In February 2010, the FDA announced they were reviewing information supplied by GSK as part of its study of Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (the RECORD Study). The FDA also announced that they were would "provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes" at a July meeting of its advisory committee.
Report of Concerns with RECORD Trial
According to the New York Times, Dr. Thomas Marciniak, who reviewed the data submitted as part of GSK's RECORD study, found there were a number of instances in which patients appeared to have suffered serious cardiac events that were not included in the count of adverse events. The article stated that Dr. Marciniak conducted a closer review of the RECORD study than would normally have been performed by the FDA, in part in response to the many questions surrounding the safety record of Avandia.
The Outcome of the July 2010 Hearings
The FDA Advisory Committee met on July 13 and 14, 2010. According to the New York Times, when asked what the FDA should do about Avandia, 12 of the 33 members of the panel voted that Avandia should be withdrawn from the market, ten voted that its use should be restricted together with enhanced label warnings, seven voted just to enhance the label warnings, and three voted that nothing should be changed, with one member abstaining.
FDA Statement About Hearing and Another Avandia Trial
On July 21, 2010, the FDA announced that a partial clinical hold, which halts enrollment of new patients in a clinical trial, had been placed on an ongoing clinical trial of Avandia, that it was evaluating the discussions at the advisory committee meeting and available information on Avandia's safety, and that it would announce the outcome of its review when the review was complete.
- U.S. FDA: Information for Healthcare Professionals Rosiglitazone maleate
- U.S. FDA Drug Safety Communication: Ongoing Review of Avandia (Rosiglitazone) and Cardiovascular Safety
- New York Times: Caustic Government Report Deals Blow to Diabetes Drug; Gardiner Harris; July 9, 2010
- New York Times: F.D.A. Panel Votes to Restrict Avandia; Gardiner Harris; July 14, 2010
- U.S. FDA: FDA Statement on Avandia TIDE Trial
- Photo Credit lump sugar in a glass sugar-basin image by Maria Brzostowska from Fotolia.com
Lyrica is Pfizer's brand name for the drug pregablin. The FDA approved Lyrica for the treatment of fibromyalgia in 2007. It is...