Breaking News: Revenge of the Gila Monster?

August 20, 2008

gila-monster.jpgCommentary by Rachana Jani MD, PGY-2

As recently reported in ShortCuts, Byetta recently made headlines after the suggestion of a mortality benefit for patients taking the drug in a small subset of the Accord study.  So is this the new golden drug for diabetics? Perhaps not. This week, the FDA updated a previous alert warning providers about the risks of pancreatitis in patients taking Byetta. Last October, the FDA first issued an alert after there had been 30 postmarketing reports of acute pancreatitis in patients who had recently been started on Byetta. Though concerning, a causal relationship was difficult to ascertain and it was believed that patients had more than 1 risk factor for pancreatitis. Many physicians continued to prescribe the drug due to its differentiated clinical profile and the rare incidence of the disease given that hundreds of thousands of patients had been started on the drug without consequence.  However, since October, 6 additional cases of necrotizing pancreatitis have been reported, and 2 of these patients died in the interim. The FDA is now working with Amylin for a more prominent warning label about the risk of necrotizing pancreatitis. Though still argued to be a rare adverse outcome, the number of lawsuits is beginning to pile. This, in addition to more user-friendly options, such as Januvia, which comes in pill form, may lead to the end of the Byetta era.

Image courtesy of Wikimedia Commons, Gila monster