Tue Oct 16, 2007
WASHINGTON (Reuters) – Amylin Pharmaceuticals Inc’s and Eli Lilly and Co’s diabetes drug Byetta may be linked to cases of acute pancreatitis in some patients, U.S. health officials said in an alert issued on Tuesday.
The U.S. Food and Drug Administration said it has reviewed 30 reports of pancreatitis in patients taking Byetta, known generically as exenatide.
“An association between Byetta and acute pancreatitis is suspected in some of these cases,” an FDA alert said.
Amylin has agreed to add information about acute pancreatitis to the precautions section of Byetta’s label, the FDA said.
Shares of Eli Lilly and Amylin were off 1.3 percent and 4.5 percent, respectively, in afternoon trading after the FDA alert. Shares of Alkermes Inc, the drug-delivery technology of which is being used to develop a long-acting version of Byetta, were down about 5 percent.
Officials at Amylin were not immediately available for comment. A Lilly spokeswoman had no immediate comment.
The FDA said doctors should tell patients taking Byetta to seek prompt medical care if they develop unexplained, persistent severe abdominal pain, which may or may not be accompanied by vomiting.
Byetta should be discontinued should pancreatitis be suspected, the FDA said. Should pancreatitis be confirmed, Byetta should not be restarted unless an alternative cause is identified, the agency advised.