The injected Type 2 diabetes drug exenatide (brand name Byetta) has been in the news this week because of safety concerns. The U.S. Food and Drug Administration (FDA) announced on August 18 that six cases of severe pancreatitis have been reported in people taking Byetta since October 2007.
Last October, the FDA issued an alert that 30 cases of acute pancreatitis in people taking Byetta had been reported; you can read more about that news in Jan Chait’s blog entry “Byetta Garners Pancreatitis Warning.” At that point, manufacturer Amylin Pharmaceuticals, Inc., agreed to add information about pancreatitis to the “precautions” section of Byetta’s label.
However, since cases have continued to be reported, the FDA stated this week that it is now working with Amylin on another labeling revision “to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.”
In the six most recent cases, all of the people with pancreatitis were hospitalized, and two died. One person who developed pancreatitis while taking Byetta filed a personal injury lawsuit against Amylin this week, alleging that the manufacturer did not adequately test and monitor Byetta’s side effects or warn doctors and people taking Byetta of pancreatitis risk.
The FDA is reminding people who take Byetta to seek medical attention immediately if they have signs of pancreatitis: severe, unexplained abdominal pain, which may or may not be accompanied by nausea and vomiting.
While the prospect of developing pancreatitis is frightening, it is also important to remember that 36 cases of pancreatitis have been reported to the FDA while more than 700,000 people around the world have taken Byetta. In other words, these cases represent about five thousandths of one percent of people who have taken Byetta.
You can learn more about how Byetta works in the article “Exenatide and Pramlintide: New Meds on the Block.”