FDA Warns of Pancreatitis Risk with Byetta
According to the FDA’s web site:
“Update 8/18/2008: Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.
Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.
FDA is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.”
This news could not have come at a worse time for Amylin (NASDAQ:AMLN), who makes Byetta or their partner Lilly (NYSE:LLY). Just when it looked like the stock was recovering that light at the end of the tunnel has turned out to be a freight train instead of a buyout offer.
At this writing neither Amylin nor Lilly has issued a public statement on the FDA’s action. Nor has Diabetic Investor been able to speak with the FDA’s press office. This being the case Diabetic Investor is giving Amylin the benefit of the doubt as this issue with pancreatitis has been well known for some time. Not to minimize the situation the numbers should be kept in perspective. There are nearly 800,000 patients taking Byetta and the incidence of pancreatitis is low when one considers that patients with diabetes are at greater risk for pancreatitis.
One has to wonder what impact this news will have on Novo Nordisk (NYSE:NVO) who’s GLP-1 Liraglutide is awaiting approval at the FDA.
It goes without saying that Amylin shares are getting hammered on the news. For the time being Diabetic Investor is standing with Amylin as this is not a new issue. Our stance may change as more information becomes available as like others we would like more clarity on the situation. According to officials at Amylin they will be making a statement later in the day via a press release. We will keep subscribers abreast of developments.