FDA Says Diabetes Drug Byetta Caused Deaths
August 19th, 2008 | by admin |
Washington (ChatterShmatter) - Shares in drug companies Eli Lilly & Co. and Amylin Pharmaceuticals Inc. have fallen since the FDA released a statement linking their diabetes drug Byetta to numerous deaths in patients.
The drug has been approved in the US since 2005 and now appears to increase a person’s risk of developing an inflamed pancreas, a condition which can be fatal.
It is a drug injected twice a day, and assists type 2 diabetes patients to lower their blood sugar.
Amylin is based in SanDiego and its shares are down 13 percent, to $28.86, while Eli Lilly shares fell 1.7 percent.
For drug maker Amylin, the majority of their earnings over the first half of 2008 came from sales of Byetta, bad news because the FDA is planning to add a tougher warning to the label.
The FDA noted a number of cases in which Byetta users were admitted to hospital with acute pancreatitis and bleeding resulting in two of them dying.
2 Responses to “FDA Says Diabetes Drug Byetta Caused Deaths”
By Robert H Hilley IV on Aug 20, 2008 | Reply
Amylin Pharmaceuticals Diabetes Drug Byetta® the Focus of California Lawsuit
Moore Labriola LLP and The Schmidt Firm, LLP represent Virginia man who developed pancreatitis; FDA seeks more stringent warnings
SAN DIEGO–(BUSINESS WIRE)–A Virginia man yesterday filed what is believed to be the first personal injury lawsuit stemming from injuries associated with the use of Byetta®, an injectable medication for diabetes. Victor Deleon alleges in a lawsuit filed in San Diego Superior Court (Case No. 37-2008-00090003-CU-PL-CTL) that the manufacturer of the drug, San Diego-based Amylin Pharmaceuticals, Inc., and the drug’s co-marketer, Eli Lilly and Company, failed to adequately test and monitor the side effects of Byetta®, and didn’t warn doctors or patients of the risk of developing pancreatitis. Deleon was hospitalized in December of 2007 after developing the condition, which causes inflammation of the pancreas and can lead to bleeding and death.
Deleon’s lawsuit comes two days after the Food and Drug Administration (FDA) announced that it has received six reports of hemorrhagic or necrotizing pancreatitis in patients taking Byetta® since October of 2007. Two of the six patients died. In a press release, the FDA said it is“working with the maker of Byetta®” to add “stronger and more prominent warnings” to the product’s label.
Deleon’s lawsuit alleges that Amylin “failed to adequately warn prescribing physicians of the risk of pancreatitis, of measures needed to properly assess the appropriateness of prescribing the drug to certain categories of patients, and of measures doctors and patients could and should take to minimize the risk.”
In the fall of 2007, Amylin agreed to add information about pancreatitis to the “precautions” section of the Byetta® label after the FDA reported 30 post-marketing reports of acute pancreatitis associated with the drug.
“It is pretty obvious that the label change in 2007 was not adequate,” said Thomas M. Moore of Moore Labriola LLP in Newport Beach, who jointly represents Mr. Deleon with Michael Schmidt of The Schmidt Firm, LLP in Dallas, TX. “We believe that Amylin possessed data prior to the 2007 label revision that justified a stronger and more prominent warning than the precaution language that Amylin ultimately negotiated with FDA,” Moore added.
Contacts
Schmidt & Clark, LLP
Robert H Hilley IV (866) 588-0600
hilley@schmidtandclark.com
http://www.schmidtandclark.com/Byetta
By kim on Aug 22, 2008 | Reply
my mom started taking byette in 07 and was sick the whole time she was alsodx in aug 07 with pancreatic cancer i know that it can cause pancreatirus but what about pancreatic cancer