FDA Requests Further Studies of Diabetes Drug Due to Reports of Pancreatitis

By December 30, 2009Dangerous Drugs

As a pharmaceutical injury attorney, I already knew that Type II diabetes drug Byetta (exenatide) had serious safety problems. In fact, when it was approved as a stand-alone treatment for diabetes this fall, I wrote about the labeling changes the FDA required as part of that approval, which included stronger warnings on the risk of kidney problems. Just last week, a financial analyst uncovered new information related to that approval that has major implications for Byetta’s safety. According to a Dec. 23 article from Bloomberg News, the FDA required the drug’s manufacturers to conduct more studies to determine the risk of acute pancreatitis, acute kidney failure and thyroid neoplasms.
Byetta is jointly manufactured by Eli Lily & Co. and Amylin Pharmaceuticals. In its Oct. 30 approval letter, the FDA told the manufacturers that it had post-marketing reports of the three serious diseases. They included reports of hemorrhaging or necrotic pancreatitis, both of which can be fatal; acute kidney failure leading to death or kidney transplants; and thyroid neoplasms, which can lead to thyroid cancer. Because this was new safety information not known when Byetta was approved, federal law required new studies to ensure that the drug’s benefits outweighed its risks. According to the letter, some of these studies are already in progress or even completed. But because this requirement was not mentioned in the manufacturers’ approval announcement, the new announcement before Christmas caused a drop in Amylin’s stock prices.
This is disturbing news not just for investors, but also for patients and defective drug lawyers like me. Byetta’s manufacturers almost certainly withheld the information because they didn’t want to hurt the drug’s sales or their stock prices. They may have achieved those goals — at least until the financial analyst found the publicly available approval letter — but they have also withheld safety information that can help patients make the best possible decisions about their own treatment. All three of the diseases that triggered the new studies are life-altering and potentially fatal. Acute pancreatitis, a sudden and serious digestive problem, can lead to the pancreatic tissue dying (necrotizing) and bleeding into the abdomen (hemorrhaging), both of which increase the chance of death significantly. Given the risk of death or disability from these diseases, patients and doctors should know about that risk so they can discuss alternatives.


At the Lowe Law Firm, we represent people who suffered serious health complications from drugs, medical devices and treatments that turned out to have serious safety problems. Most patients don’t have the information and background to evaluate drugs’ safety; we trust manufacturers to give us only treatments they know are safe. When they fail to do so — whether or not it was intentional — families that suffered an injury, illness or death have the right to hold them legally responsible. Our dangerous prescription drug attorneys, based in St. Louis and southern Illinois, help patients and families around the United States enforce their rights by suing the negligent drug manufacturers. In a lawsuit, injured people can claim compensation for all of the steep financial costs of a pharmaceutical injury, as well as compensation for their pain, suffering and any disability or death.
If your family has suffered a serious illness or death because of a drug that was supposed to help, you should call the Lowe Law Firm to learn more about your rights and your legal options. To set up a free, confidential evaluation of your case, please contact us through the Internet or call 1-877-678-3400 toll-free from anywhere in the United States.