Personal Injury and Social Security Disability Blog

Link of the Day - Possible Link Between Diabetes Drug Byetta And Acute Pancreatitis

The U.S. Food & Drug Administration has issued a warning regarding the use of the diabetes drug Byetta. There have been reports of acute pancreatitis in patients taking this drug. Here is the text of the FDA notice:

FDA ALERT [10/2007]:  FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes.  An association between Byetta and acute pancreatitis is suspected in some of these cases. 

Healthcare professionals should instruct patients taking Byetta to seek prompt medical care if they experience unexplained persistent severe abdominal pain which may or may not be accompanied by vomiting.  If pancreatitis is suspected, Byetta should be discontinued.  If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.

FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

Stronger Warning Ordered For Ketek Antibiotic

A few days ago, the Food and Drug Administration ordered stronger warnings of potentially deadly liver failure with the antibiotic Ketek (telithromycin).

Ketek is approved to treat acute bacterial sinusitis, pneumonia, and chronic bronchitis.

The stronger warning is based on the FDA's review of Ketek's postmarketing adverse event reports. Those records show 12 cases of acute liver failure -- four of which were fatal; a fifth required a liver transplant. There were also an additional 23 cases of acute liver injury.

Ketek's new label will advise doctors and patients to watch carefully for signs and symptoms of liver injury while taking Ketek and to discontinue the drug promptly if any signs or symptoms of liver injury are to develop.

When the FDA approved Ketek in April 2004, the drug's labeling included precautions about liver injury and possible worsening of myasthenia gravis, as with other drugs in its class.