Nonetheless, Pending Byetta Label Change Will Probably Add Stronger Warnings About Severe Pancreatitis Side Effect
(Posted by Tom Lamb at DrugInjuryWatch.com)
Just last week we reported the March 2009 Drug Safety Newsletter (UK) had an article that addressed the European reports of Byetta-induced pancreatitis and brought some attention to a different, emerging drug-safety issue for Byetta users, this one being kidney, or renal, failure.
Now, a March 13, 2009 Dow Jones news report, "Study Downplays Risk Of Amylin's Byetta, But Concerns Remain", brings us the latest developments concerning the issue of whether Byetta increases the risk of pancreatitis. According to this report, the professional journal Current Medical Research and Opinion, recently published the findings of an analysis that used an insurance company database to show that neither Byetta nor Januvia -- a diabetes drug from Merck & Co. -- increased the risk for pancreatitis, which is an inflammation of the pancreas. The report points out that this new analysis was funded by Amylin Pharmaceuticals Inc., the drug company that makes Byetta, and Eli Lilly & Co., which is Amylin's marketing partner for Byetta sales in the U.S.
This March 13 Dow Jones report then addresses the pending Byetta label change:
In August, news about the deaths led the FDA to start working with the companies to add stronger warnings about severe pancreatitis to the drug's label. The label revision is expected soon, but its delay also has put off FDA approval for Byetta's use as a monotherapy.
Because diabetes patients have a higher incidence of pancreatitis than the general population, Amylin has stressed that Byetta's use doesn't statistically increase the likelihood of pancreatitis complications or death.
The pending label changes show that FDA seems to differ in that opinion.
There was no word in this March 13 report regarding when the stronger warnings about pancreatitis side effects will be added to the Byetta label -- also known as the package insert -- nor whether the new warnings will be in the form of a bolded warning or, even, a so-called "black-box" warning.
We will be watching for an announcement from Amylin and the FDA -- seemingly in the not too distant future -- about the revised Byetta label.