The makers of Byetta have agreed to include new side effects warnings on its label following reports that link the diabetes drug to the development of acute pancreatitis. According to the Food & Drug Association (FDA), the sometimes fatal Byetta side effect has been reported in dozens of patients taking the drug and some of those have gone on to develop other complications like kidney failure.

Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection. Severe cases of pancreatitis can lead to the release of toxins and enzymes into the blood stream that can injure the heart, lungs, kidneys or other organs. In some instances, acute pancreatitis can be fatal According to the FDA, 30 people have developed pancreatitis that has been associated with the use of Byetta. Of those, 5 later suffered from kidney failure. Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they quit taking Byetta.

Byetta is marketed jointly by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. The drug was approved by the FDA in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.

The changes to the Byetta side effects warnings will say that the drug has been associated with the development of pancreatitis. The FDA is also urging physicians and patients to be alert to warning signs for the disorder, including persistent and severe abdominal pain that can radiate to the back. The pain can be accompanied by nausea and vomiting. Some of these symptoms are themselves common side effects of Byetta, but the FDA said that the symptoms of pancreatitis would be much more severe and persistent. The FDA said that patients who develop pancreatitis should stop taking Byetta immediately.

Amylin and Eli Lilly agreed to update the Byetta side effects labeling at the FDA’s request. According to the companies, information about pancreatitis had already been included on the Byetta label. But the new Byetta side effects information will be more detailed and will give clear advice on what signs and symptoms doctors and patients need to be aware of.

Byetta is one of the fastest growing diabetes drugs on the market, and has been used by about 700,000 patients in the US since it was first introduced.

This entry was posted on Wednesday, October 17th, 2007 at 8:53 am and is filed under Legal News.