Avandia Concerns Lead Saudi Arabia to Suspend Drug

Saudia Arabia has banned new shipments of the diabetes drug Avandia for at least six months as a result of concerns over Avandia side effects, which could increase the risk of heart attacks, congestive heart failure, fractures and other injuries.

The Saudi Food and Drug Authority (SFDA) announced an Avandia ban on March 17, saying that the Avandia health risks appear to outweigh the benefits provided by the type 2 diabetes drug and that there are safer alternatives. The country has suspended GlaxoSmithKline PLC’s ability to market the drug in the country and has halted new shipments, but the medication will still be available in pharmacies while supplies last.

In a SFDA Avandia safety evaluation report (pdf) from February 27, Saudi investigators cited a recent U.S. Senate report that 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.

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 Avandia concerns have mounted about the risk of serious and potentially life-threatening side effects. 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.

“There is no evidence that rosiglitazone offers any unique health benefit while there is strong evidence that rosiglitazone results in an increased risk of acute myocardial infarction and heart failure compared to pioglitazone,” the Saudi report concluded.

Pioglitazone is the medical name for Actos, manufactured by Takeda Pharmaceuticals North America, Inc. and is a competitor drug to Avandia. Both are members of a class of medications known as thiazolidinedione agents, which are used to treat type 2 diabetes by helping control blood sugar levels.

GlaxoSmithKline will have six months to present evidence to the SFDA to convince the Saudi agency that the ban should be reversed, otherwise it is likely that a permanent recall for Avandia will be issued.

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.