"WASHINGTON – The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.
The consumer group, Public Citizen, filed a petition with the Food and Drug Administration to have Avandia taken off the market.
It was the second setback in as many weeks for the GlaxoSmithKline medication, which at one time had shown great promise in reducing the blood sugar levels of people with Type 2 diabetes. Last week, the American Diabetes Association and a European counterpart jointly released updated treatment guidelines for doctors that pointedly recommended against using Avandia.
"The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities," Public Citizen said in its petition. "Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure."
The FDA said it will "carefully review" the petition, and it continues to monitor Avandia's safety record.
Avandia's heart risks were brought to light two years ago in a medical journal article that reported a 43 percent 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 said its own research 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, in a statement, said it does not 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 said the data on heart attacks is inconclusive and that Avandia is safe and effective, when used according to directions. Glaxo shares initially fell on the news, but later rose to close at $37.90, up 1.6 percent."
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