On August 18, 2008, the U.S. Food & Drug Administration (FDA) announced plans to strengthen the warning labels on Byetta. Byetta is a medication designed to control blood sugar in adults with type II diabetes. It is administered by injection, twice daily. New warnings were needed because of six hospitalizations and two deaths of Byetta users. These deaths were caused by hemorrhagic or necrotizing pancreatitis. The warning came too late. The FDA knew there were problems with Byetta, almost a year earlier.
In October 2007, a Health Alert was issued by the FDA, due to the report of 30 cases of acute pancreatitis (sudden inflammation of the pancreas). Twenty-one of those patients were hospitalized, of that five had serious complications. In addition, the condition of twenty-two patients improved after they stopped taking Byetta. Because of this, the FDA asked Byetta’s manufacturer, Amylin Pharmaceuticals to add new warnings to Byetta. Amylin agreed to add information about acute pancreatitis in the PRECAUTION section of the label. It has been alleged Amylin never followed through on their promise to add the 2007 warning. If this is true, the FDA never fulfilled their promise to the public.
Byetta has dangerous side effects. Since the Health Alert in October 2007, the FDA has received reports of six cases of hemorrhagic pancreatitis (inflammation of the pancreas which leads to bleeding) or necrotizing pancreatitis (the inflamed pancreas destroys itself) in patients using Byetta. Six patients had to be hospitalized and two subsequently died. This recent report prompted the FDA to again ask Amylin Pharmaceuticals to add warnings to Byetta. This time, the FDA wanted “stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.”
However, even this suggested warning is not strong enough. Byetta has been shown to cause death and serious injury. The public has a right to be warned about death or serious injury if they take Byetta. Byetta is a hugely popular diabetes drug because of the weight loss most users experience while on Byetta. More than 700,000 people have taken Byetta since June 2005. Byetta is not the only drug available to help control blood sugar for diabetics. The FDA approved it only three years ago. In that short time, two warnings have been issued. The public cannot wait for the FDA to decide how many more people have to die or be seriously injured before appropriate action is taken.