Diabetes Drug Could Be Deadly, Group Warns

Public Citizen Asks FDA To Pull Avandia Due To Heart, Liver Risks

(AP)  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."

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.

There was no immediate response from the FDA.

[puzzler125]

"The company''s own data" is never valid in a study! That''s why outside companies do them!

[lonestartnow]

There are obviously other drugs for other conditions that are (maybe--maybe not) more dangerous than the original condition due to side effects. But type 2 diabetes is closely linked to obesity, and in the majority of cases is a preventable condition. How about preventing it through a healthier diet and increased physical activity--no side effects! How about a greater attempt to control it the same way?

[psk123-2009]

The side effects from many of these new drugs can be much worse than an untreated problem in the first place. I watch carefully everything that comes out for heart disease and diabetes. Both of these problems run through my family to the point where nearly half have one or both.

[pulto1]

I was prescribed Avandia for several months and my body blew up like a baloon. I really got concerned and made an appointment w ith my physician. His eyes widened, and the words that came out of his mouth were "My God" what is happening to you?" He immediately took away the Avandia. A month later I had two TIAs then a CVA, a major stroke. I will always wonder if the Avandia was instrumental in my strokes...