Avandia Heart Safety Data Still Being Reviewed by FDA

Following the release of a scathing Senate report, which revealed that some federal health officials have been calling for a recall of Avandia since at least 2007, the FDA announced Monday that the agency is still reviewing safety data on the diabetes drug and conclusions will likely not be released until a public meeting scheduled for July 2010.

Over the weekend, a staff report by the Senate Finance Committee highlighted concerns about the heart side effects of Avandia, indicating that removing the drug from the market may prevent 500 heart attacks and 300 cases of heart failure each month if diabetes patients were given a different drug instead. The report also suggested that the drug’s maker, GlaxoSmithKline PLC, was aware of the cardiac problems with Avandia, but attempted to minimize or misprepresent the risks to keep the drug on the market.

According to a statement posted late Monday on the FDA MedWatch website about the agency’s ongoing review of Avandia heart safety data, the FDA indicates that no conclusions or recommendations about the use of Avandia to treat type 2 diabetes have been reached at this time. However, the FDA cautioned that patients should continue taking Avandia unless they are told by the doctors to stop.

The FDA is currently reviewing a new GlaxoSmithKline study, the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD), which suggests Avandia side effects include the same heart risks as other drugs in its class. However, the RECORD study has already come under fire by a number of critics who say that the 2,000-patient study was too small and not well designed to look for cardiovascular risk. The original 2007 study looked at more than 14,000 patients.

“Once FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010,” the FDA announced. “At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.”

GlaxoSmithKline released a statement following the Senate report claiming that congressional staff members cherry-picked data and findings, and pointed to the FDA’s previous conclusions that Avandia was still safe enough to be left on the market. The company says it has consistently shared data with the FDA, contrary to the reports assertions that it knew about and tried to hide and downplay data that revealed Avandia heart attack risks.

However, a March 2008 FDA warning letter to the company in the wake of inspections of its U.S. corporate headquarters concluded the opposite.

“Our inspection revealed that your firm failed to report data relating to clinical experience, along with other data and information, for Avandia,” the letter states.

The drug maker currently faces thousands of Avandia heart lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania, where the first trials are expected to begin later this year.