FDA Records 2 More Deaths Due To Byetta
Submitted by Carina Rose on Tue, 08/19/2008 - 09:05
The U.S. Food and Drug Association issued a warning to doctors and
patients, through its web site, about life-threatening pancreas problems linked to the type 2 diabetes drug Byetta, of Amylin Pharmaceuticals, after receiving two more reports of deaths and four other hospitalizations in Byetta users.
Those patients had reported hemorrhagic pancreatitis (inflammation of the pancreas with bleeding) or necrotizing pancreatitis (in which the inflamed pancreas destroys itself).
All six patients were hospitalized, and they were put off Byetta treatment. The four survivors were in the process of recovering at the time that the FDA learned of their illness.
The news caused investors to pull away from the stock. Shares of Amylin dropped 14.5%, or $4.92, to $29.29, in late-afternoon trading.
Byetta is a twice-daily injection. It was approved in 2005 for the lowering of blood sugar in patients with type 2 diabetes.
In October, the FDA examined 30 reports of pancreatitis in patients being treated with Byetta. This propelled Amylin to agree to add information about the risk to its drug label and to alert doctors about the problem. Before the recent report, no one had died from the complication.
More than 200 million people have diabetes across the world and approximately 90.0% to 95.0% have type 2 diabetes, which generally affects overweight people late in life. Byetta had sales of $636.0 million in the United States in 2007, with only $14.2 million in another places.
