FDA Issues Warning to Makers of Ergotamine Drugs

Migraine remedies produced without FDA approval

FRIDAY, March 2 (HealthDay News) -- The U.S. Food and Drug Administration has ordered eight manufacturers and 12 distributors of products containing ergotamine tartrate to cease marketing. The drugs in question, typically marketed for migraine, were manufactured without FDA approval. They also have inadequate health warning labels about possible interactions with CYP 3A4 inhibitors, including antifungal agents, protease inhibitors and antibiotics, which can cause side effects such as ischemia, gangrene and death.

There are five approved ergotamine-containing products on the market, which have the appropriate boxed warning on the label.

The FDA's action against the firms is part of a wider campaign to ensure consumers' access to safe, approved drugs. The FDA estimates that about 2 percent of prescribed drugs are unapproved, because they were on the market prior to the Federal Food, Drug and Cosmetic Act. "Unapproved drugs pose real risks to the American public," said Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, in a statement.

The firms have 15 days to respond with a discontinuation plan. Manufacture and distribution must cease in 60 and 180 days, respectively.

More Information -- FDA
More Information -- Letters to Manufacturers

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