Avandia Recall May Be Coming, FDA Considering Halt of Safety Study: Report

The FDA is considering whether to stop a diabetes drug safety trial due to concerns over the heart risks with Avandia, according to a report in the Wall Street Journal. The decision about whether to halt the trial will likely be linked to the agency’s view on the safety of the drug, and there is speculation that it may be a prelude to an Avandia recall.

FDA Commissioner Margaret Hamburg sent a letter to U.S. Senator Charles Grassley last week saying that the FDA is considering shutting down a comparative study on the side effects of GlaxoSmithKline’s Avandia and Takeda Pharmaceutical’s Actos diabetes drugs over concerns about the ethics of continuing the trial. If the study is shut down because the FDA deems exposing clinical subjects to potential Avandia health problems is unethical, it is an indicator that the FDA could recall Avandia for the same reasons.

According to the letter, first reported by the Wall Street Journal, the FDA has not yet made a decision on the clinical trial, called TIDE, which is comparing the two drugs’ heart risks. FDA officials have said that canceling the trials cannot be “de-linked” from the FDA’s view on the safety of Avandia, suggesting that if the trials are halted, the FDA may ask Glaxo to pull Avandia from the market.

Avandia (rosiglitazone) was approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years as concerns have mounted about the risk of serious and potentially life-threatening heart risks with Avandia. Some experts estimate that Avandia has caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.

A recent U.S. Senate report determined GlaxoSmithKline knew that Avandia caused heart problems, but failed to inform the U.S. drug regulators. The Senate report also revealed that some FDA drug safety reviewers have been calling for an Avandia recall since 2007. Senator Grassley is the ranking member of the Senate Finance Committee which issued the report after a two year investigation.

Concerns about the risk of heart problems with Avandia first gained widespread attention in May 2007, when a meta-analysis of 42 different clinical trials was published in the New England Journal of Medicine, suggesting that users of Avandia had a 43% increased risk of a heart attack.

In the United States, GlaxoSmithKline PLC currently faces thousands of Avandia 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.