A diabetic patient who developed pancreatitis as a side effect of Byetta has filed a lawsuit in a California state court. This is reportedly the first Byetta lawsuit to be filed in the United States involving pancreatitis.
The personal injury lawsuit was filed on August 20, 2008, by Victor Deleon in the San Diego Superior Court. Deleon was hospitalized in December 2007 with pancreatitis after using Byetta, an injectable medication used for treatment of type 2 diabetes.
The complaint was filed against Amylin Pharmaceuticals Inc., the San Diego-based manufacturer of Byetta, and Eli Lilly & Co., the co-marketer of the diabetes drug.
The Byetta lawsuit alleges that the defendants failed to adequately test and monitor the side effects of their drug, and failed to issue prominent warnings on the label about the risk of pancreatitis.
Byetta is the brand name of exenatide, which is injected subcutaneously twice a day to help diabetics reduce their blood sugar levels. It was approved by the FDA in April 2005, and it has been used by over 700,000 people in the United States. The diabetes drug generated sales of about $636 million in 2007.
In October 2007, the FDA issued a statement that they had received 30 post-marketing reports involving the development of acute pancreatitis in patients taking Byetta. At that time, the FDA and Amylin Pharmaceuticals Inc., changed the labeling to include additional information about the risk of pancreatitis under the ‘Precautions’ section.
On August 18, 2008, the FDA issued a second alert to healthcare providers about six additional cases of necrotizing or hemorrhagic pancreatitis among users of Byetta. These six new cases, which involved severe forms of pancreatitis, occurred after the October 2007 warnings. All six patients were hospitalized as a result of the pancreatitis, and two of them died.
The FDA and Amylin Pharmaceuticals Inc. are currently working on changing the labels on the drug again to add stronger language, which will be placed more prominently, about the risk of acute pancreatitis from Byetta.
Deleon’s Byetta lawsuit alleges that the defendants possessed information about the risk of pancreatitis due to Byetta, but failed to take steps which could have prevented the serious and potentially life threatening condition for users.