Since a meta-analysis was made public in May 2007, Avandia, GlaxoSmithKline’s diabetes drug, has come under fire. The meta-analysis showed the medicine was increasing the risk of heart attacks for those taking the medication. A black box warning was required to be placed on the drug’s label. Now Avandia-induced liver failures have been seen and a black box warning has been placed on the label for this particular adverse event.

As a result of these updated warnings, a couple of well known physician associations have made recommendations against the use of this drug. Guidelines issued recently by the American Diabetes Association and the European Association for the Study of Diabetes said members of a joint medical panel “unanimously advised against using Avandia.” After this recommendation, on October 30th Public Citizen asked the FDA to ban the drug. FDA officials have indicated that there is a split within the agency about whether to pull Avandia off the market or allow it to stay with stronger warnings.

Public Citizen believes the government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage. The consumer group filed a petition with the Food and Drug Administration to have Avandia taken off the market. Public Citizen said in the petition:

The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities. Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure.

Avandia’s heart risks were brought to light two years ago in a medical journal article that reported a 43% higher risk of heart attacks among Avandia patients when compared with those taking other diabetes drugs. Although scientists are still debating a link between the drug and heart attacks, concerns about the medical evidence led to stronger warnings. As a result, Avandia use dropped sharply, but about a million U.S. patients still take it. Public Citizen’s own research has found 14 cases of liver failure associated with Avandia, 12 of which led to death. The petition also said Avandia predisposes some patients to eye problems, anemia and bone fractures.

Glaxo still says it doesn’t believe Avandia causes liver failure. The company said its own data shows the drug has a good safety record when it comes to liver problems. The company claims the data on heart attacks is inconclusive and that Avandia is safe and effective when used according to directions. Avandia sales have fallen sharply since the May 2007 report which appeared in the New England Journal of Medicine. However, approximately ten thousand prescriptions are still being filled daily for Avandia according to Public Citizen. With other safer and similar treatments on the market, why is the FDA waiting to act? Hopefully, the new administration in power will step in and allow federal agencies to return to their job of protecting consumers rather than protecting the interests of big business as has been done under the Bush Administration. If you want more information on Avandia contact Frank Woodson at 800-898-2034 or e-mail at Frank.Woodson@beasleyallen.com.

Source: Wall Street Journal and Associated Press

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