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FDA updates alert for exenatide
Additional cases of pancreatitis have been reported.
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According to the FDA, within the last year, six cases of hemorrhagic or necrotizing pancreatitis have been reported in patients taking exenatide for type 2 diabetes.
In October of 2007, the FDA issued an alert for health care professionals after reviewing postmarketing reports for exenatide (Byetta, Amylin Pharmaceuticals Inc.), which revealed 30 cases of pancreatitis linked to the drug.
Of the six cases mentioned in the updated alert, all required hospitalization, two died and four were recovering at the time the report was made.
On August 26, one week after the FDA alert, Amylin and Eli Lilly held a conference call to acknowledge the alert and address the concern and confusion that followed the FDA's update. According to the companies, they were aware of the six pancreatitis cases referenced in the alert, as well as others, and had reported all events to the FDA.
The companies continue to pursue a comprehensive drug safety program for exenatide to review individual cases and both clinical and epidemiological data, according to a press release. Though a definitive causal relationship between exenatide and pancreatitis has not been proven, they acknowledge the importance to better understand the relationship between the two.
The FDA urged health care professionals to discontinue exenatide in patients who present with signs or symptoms of pancreatitis. Once pancreatitis is confirmed in these patients, the FDA recommended appropriate treatment and monitoring until recovery.
The FDA recommended against the re-initiation of exenatide following recovery, but instead suggests alternative antidiabetic therapies.
In addition to the already-present pancreatitis warning in the “precautions” section of the product labeling information, the FDA is working with the pharmaceutical company to develop more prominent warnings.
We've probably only seen the tip of the iceberg because physicians are reluctant to fill out reports when these events occur; there are probably many more cases and the FDA should act accordingly. The truth of the matter is that the fox is guarding the hen hut. If you want to report an adverse event, you have to go through the drug company, not the FDA and you have to fill out a stack of paperwork. There must be many unreported cases because doctors have reluctance to report adverse effects.
– David S.H. Bell, MB, FACE
Endocrine Today Editorial Board member