FDA seeks tougher labeling for Byetta after deaths

They warned you once and they'll warn you again. FDA is upping the label ante on Byetta, the diabetes drug that Eli Lilly and Amylin Pharmaceuticals developed and market, following reports of deaths in patients taking the drug. Greater than 700,000 patients have used the medication since 2005, bringing the companies nearly $700 million in sales.

Patients taking the twice-daily injectable drug Byetta are at increased risk of acute pancreatitis, a dangerous form of pancreatitis that comes on suddenly and can be rapidly fatal, even with treatment. The FDA is warning patients on Byetta to stop taking the medication immediately if they develop symptoms of acute pancreatitis, including abdominal pain, nausea, vomiting, diarrhea, fever and chills.

The two drug companies say the reports of complicated or fatal pancreatitis are "very rare," and that diabetes patients already have an increased risk of pancreatitis.

The medication already had warnings following about 30 reports of nonfatal pancreas concerns in Byetta patients, but now the FDA has received at least six new reports of patients taking Byetta coming down with an aggressive type of pancreatitis. Of these, two have died.

For their parts, Lilly and Amylin are in the process of developing a once-a-week version of the medication that had piqued some investor interest despite recent lackluster sales, but this news has some analysts raising a red flag about investing, saying that it will likely influence how the FDA will view the new version. Not surprisingly, shares in both companies saw a dip in price on Monday.

--see the release [1]
--read the story [2] in the New York Times
--see more [3] at ABC News
--find the Pharmalot blog post [4]

Related Articles:
Does Lilly's Byetta extend life? [5]
Lilly diabetes med linked to pancreatitis [6]
Byetta - Top 10 Drug Warnings and Recalls [7]
FDA Updates Information for Healthcare Professionals for Byetta [8]
Novo drug bests Byetta in ADA study [9]
Novo: no pancreatitis risk linked to Liraglutide [10]