August 20, 2008
FDA Warns of Byetta Complications as Two Die
Federal inspectors in the US issued warnings that the diabetes type II drug Byetta may cause hemorrhagic pancreatitis after two patients died from related complications. The drug is manufactured by Amylin Pharmaceuticals and jointly marketed with Eli Lilly.
On Monday, the Food and Drug Administration website warned physicians and patients to be cautious while taking Byetta for the treatment of type II diabetes. The website said that since the last review of the drug’s post-marketing material, as many as six patients undergoing treatment with the drug have been hospitalized due to necrotizing or hemorrhagic pancreatitis with two of them succumbing to severe complications.
FDA authorities said that they will advise Amylin to come up with stronger warnings on the labels of the drug and also asked patients taking Byetta to discontinue the medicine if experiencing any symptoms of pancreatitis.
News of the potentially fatal side effects of Byetta led to a fall in the share prices of Amylin which dropped by 14.5 percent or $4.94 to $29.29. Byetta is a popular treatment for type II diabetes in the US and is also known as exenatide. In 2007 the drug recorded domestic sales of $636 million and $14.2 million outside the country.
















