The F.D.A. has announced a severe restriction of the diabetes drug Avandia, which can be linked to an estimated 47,000 people who suffered heart attacks while taking the drug between 1999 and 2009. The drug is banned in Europe, and patients in the U.S. can only be prescribed it if their doctor determines “they have tried every other diabetes medicine and that patients have been made aware of the drug’s substantial risks.” Questions were raised about the popular drug as early as 2007 after studies began to connect Avandia to heart problems. The decision marks a much harder line taken by government agencies on drug safety issues. Garniner Harris, The New York Times 09/23/2010
Read Article: The New York Times
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226975.htm

The Federal Joint Committee’s chairman, Rainer Hess, noted in a statement that there are other medications that do not have the same side effects or long-term risks as Avandia and called for patients to be protected against “useless and, more importantly, harmful therapies.” GlaxoSmithKline defended its drug, saying, “The committee’s course of action is not justified neither from a medical, nor legal point of view.”

Avandia is not the only medication affected by the recommendations. Actos, made by Takeda, is included in the recommendations.

Meanwhile, an unpublished study by FDA drug safety official David Graham alleges that Medicare patients suffered up to 48,000 heart attacks, strokes and other Avandia side effects, which could have been avoided if those patients had taken other medications. Although the study is unpublished, an FDA official said data from that study would be included in next month’s Avandia safety review.

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The move by Germany’s Federal Joint Committee, consisting of doctors and health insurers, is the latest blow to GlaxoSmithKline’s attempts to keep Avandia on the market. In reaching its decision to tell insurers not to offer Avandia reimbursements, the committee cited growing evidence that side effects of Avandia cause heart problems. The move is almost certain to kill Avandia sales in Germany.

In the United States, the FDA is currently reviewing the safety of Avandia, and is planning to hold meetings next month to consider what should be done to protect consumers. Some officials within the FDA have been calling for an Avandia recall for several years, suggesting that strokes and heart attacks from Avandia may be responsible for the death or serious injury of more than 100,000 Americans since the medication was first approved.

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The draft Avandia study (pdf) was performed by drug safety reviewers from FDA and the Centers for Medicare and Medicaid Services (CMS). According to a story by Pharmalot, a drug reviewer at the FDA is pushing for the study to be published in a medical journal in the near future, while the FDA is continuing its own analysis of the safety of GlaxoSmithKline’s diabetes drug.

The researchers performed an observational study looking at data from more than 227,000 Avandia users over the age of 65 and compared those with users of the competing diabetes drug Actos, by Takeda Pharmaceuticals. They found that in that age group, Avandia increased the risk of stroke by 27%, the risk of heart failure by 25%, and the risk of death by 13%. Overall, the researchers estimated that 48,000 elderly users experienced an event attributable to Avandia side effects.

“Given that 62% of [Avandia] use has been in patients below age 65, the actual national impact is probably 100,000 or more,” the researchers concluded.

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