Problems with Byetta Production Plant Identified by FDA

FDA inspectors have identified a number of quality control and training issues at Amylin Pharmaceutical’s Byetta manufacturing plant in Ohio, just as the agency prepares to decide whether to approve a new formulation of the diabetes drug and concerns mount about potentially serious side effects of Byetta

According to an FDA inspection report (pdf) released last week, raw materials used to make Byetta were not properly inspected coming into the plant, and workers in a variety of positions at the West Chester plant, near Cincinnati, Ohio, have not been properly trained to ensure quality control.

Byetta is a type 2 diabetes drug that is manufactured and distributed jointly by Amylin and Eli Lilly & Co. The drug is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. The drug makers are currently seeking approval for a new long-acting formulation of the drug, which would allow users to take one injection per week, instead of the current twice-daily dosing regimen. A decision on the drug approval is expected this week.

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According to the FDA’s inspection report, the plant failed to establish or follow procedures designed to prevent contamination of drug products that are supposed to be sterile. The plant also failed to test in-process materials properly for quality and purity, and did not follow up on investigations into unexplained discrepancies and failures of batches of drugs.

The inspection report follows an FDA warning issued in January about off-label promotional statements for Byetta at a conference in June.

The production issues also add to recent concerns about potential health problems with Byetta, which has been linked to a risk of kidney failure and pancreatitis. In November, the FDA issued a new warning indicating that they have received at least 78 post-marketing reports that link Byetta kidney problems, including 62 cases where the users experienced kidney failure. And in October 2007 and August 2008, the FDA issued safety alerts about reports of Byetta pancreatitis cases, including severe reports of hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal.

Amylin and Eli Lilly also currently face a number of Byetta lawsuits involving allegations that the drug makers failed to adequately warn about the risk of pancreatitis and kidney failure.

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