Product News and Recalls

FDA warning on Byetta spooked investors

A report on the blog FiercePharma says that a more stringent warning label for the diabetes drug Byetta spooked some investors when the U.S. Food and Drug Administration issued it in 2008.

At the time, Byetta manufacturers Eli Lilly and Amylin Pharmaceuticals had been in the process of developing a version of the drug that had to be administered only once a week, as opposed to the twice-daily version then on the market.

But following reports of deaths in patients taking Byetta, the FDA issued a warning that users are at increased risk of acute pancreatitis, which is a dangerous form of pancreatitis that comes on suddenly and can be deadly even with treatment.

The agency warned patients on Byetta to stop taking the medication immediately if they developed symptoms of acute pancreatitis such as abdominal pain, nausea, vomiting, diarrhea, fever and chills. Another study has linked Byetta to an increased risk of thyroid cancer.

Studies have linked another diabetes drug, Januvia, to a similar risk of pancreatitis and pancreatic cancer.

The report says Lilly and Amylin had piqued some investor interest from their research into the once-a-week version of Byetta. The FDA warning, however, had some analysts raising red flags and shares in both companies saw a dip in price.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a Lopez McHugh attorney if you or a loved one was diagnosed with pancreatic cancer after taking Januvia or Byetta.

http://www.fiercepharma.com/story/diabetes-drug-death-reports-prompt-tougher-labeling/2008-08-19