If you take Byetta to help control type 2 diabetes, you need to know that this drug has been linked to serious side effects that could lead to severe injury -- or death.
Byetta, made by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., is used to control type 2 diabetes. Available in the U.S. marketplace since June 2005, Byetta has been taken by more than 700,000 patients around the world.
When Byetta was introduced, many healthcare professionals stated that the drug represented a dramatic improvement over other diabetes medications. However, serious questions have now been raised about the drug's safety.
In August 2008, the Food and Drug Administration notified healthcare professionals that Byetta had been linked to two deaths and four hospitalizations. The six patients developed severe pancreatitis, including hemorrhagic pancreatitis (swelling and severe bleeding of the pancreas) and necrotizing pancreatitis (rapid decay and death of organ cells).
Those injuries and deaths prompted the FDA to begin work on a stronger warning label for Byetta. It's possible that Byetta will soon carry a Black Box warning -- the most serious caution issued by the FDA. A Black Box warning indicates a prescription drug carries a significant risk of severe side effects or death.
This is the second time in 10 months that Byetta has been linked to pancreas injuries. An October 2007 FDA Alert reported on 30 cases of acute pancreatitis among Byetta users. Twenty-one of those patients had to be hospitalized, and five had serious complications. Acute pancreatitis can be a life-threatening condition, resulting in severe breathing problems as well as kidney failure. The agency asked Amylin to include information about pancreatitis in the precautions section of the drug's labeling.
Apparently, there is no way to tell when pancreatitis in Byetta users will develop into the most severe forms of the disease. The FDA notes that "are no known patient characteristics which determine when pancreatitis associated with Byetta will be complicated by the hemorrhagic or necrotizing forms of this condition."
Current users of Byetta who are concerned about the adverse events associated with this drug should contact their doctor before discontinuing use. Users should immediately contact their doctor if they experience symptoms of acute pancreatitis. Those symptoms include abdominal pains, vomiting, fever, swollen or tender abdomen, rapid pulse and nausea.
If you or someone you love has been harmed by the use of Byetta, you may be entitled to compensation for your injuries. Our qualified pharmaceutical lawyers can help you determine if you have a case. For more information or to schedule a free case evaluation, contact the lawyers of Gordon & Doner today at 1-800-659-1159.
