FDA Orders Halt to Manufacture of Unapproved Ergotamine Drugs

Article excerpt

The Food and Drug Administration has told eight manufacturers and 12 distributors of unapproved ergotamine-containing drugs to stop marketing these products because of concerns about inadequate safety labeling.

On Feb. 27, the FDA issued warning letters to 20 firms that market unapproved prescription drugs containing ergotamine tartrate. The firms have 60 days to stop manufacturing the products and 180 days to stop distribution. Drugs containing ergotamine tartrate are used to treat vascular headaches, including migraines.

"Consumers and physicians may wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said Michael Levy, director of the agency's division of new drugs and labeling compliance in the Center for Drug Evaluation and Research, during a telephone news conference.

"This action is the next step in an aggressive FDA initiative to ensure that all marketed U.S. drugs have required FDA approval," Mr. Levy said.

There are currently five approved ergotamine-containing drugs: Migergot suppositories (marketed by G & W Laboratories Inc.), ergotamine tartrate and caffeine tablets (marketed by West-Ward Pharmaceutical Corporation and Mikart), Cafergot tablets (marketed by Sandoz), and Ergo-mar sublingual tablets (marketed by Rosedale Therapeutics).

The approved drugs' labels include a black box warning regarding the use of these products with CYP 3A4 inhibitors, including some antifungal drugs, protease inhibitors, and certain antibiotics. …