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FDA Reports 2 Deaths Linked to Byetta Diabetes Drug

The U.S. Food and Drug Administration (FDA) announced on Monday that it has received six reports of life-threatening pancreas swelling in patients taking the diabetes medication Byetta, including two deaths. The agency is working with Byetta manufacturer Amylin Pharmaceuticals, Inc. to strengthen the drug's warning label.

Byetta is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes, along with metformin and/or another type of antidiabetic medicine called sulfonylureas, according to an FDA Patient Information Sheet. The six diabetes patients referenced in Monday's FDA announcement experienced "hemorrhagic or necrotizing pancreatitis," and all six required immediate hospitalization. Two patients died, while four appear to be recovering. While the FDA and Amylin will work to revise Byetta's labeling information, Reuters reports that it is unclear whether those revisions wil include a "black-box" label, the agency's strongest type of warning for medications.

• FDA's Updated Warning on Byetta
• Reuters: U.S. Seeks More Warnings for Amylin Diabetes Drug
• FDA Patient Information Sheet on Byetta
• WebMD: FDA Notes 2 Byetta Deaths
• Pharmaceutical Drug Liability (FindLaw)
• Things You Should Know: Taking Prescription Medications (FindLaw)

Full post as published by FindLaw's Common Law on August 20, 2008 (boomark / email).