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ROCKVILLE, Md. -- The FDA has ordered 20 firm to stop marketing grandfathered prescription versions of the vasoconstrictor ergotamine tartrate, an old remedy for treatment of vascular headaches, including migraine.
ROCKVILLE, Md., March 2 -- The FDA has ordered 20 companies to stop marketing grandfathered prescription versions of the vasoconstrictor ergotamine tartrate, an old remedy for treatment of vascular headaches, including migraine.
The agency's complaint was outlined in warning letters to eight drug makers and 12 distributors. It hinges on the lack of approval and of proper package labeling on the older formulations which, while sold only by prescription, came on the market before changes to the Food, Drug, and Cosmetics Act required more thorough warning labels.
Five FDA-approved ergotamine-containing products will remain on the market, albeit with a black-box warning against concomitant use of such products with drugs that potently inhibit the cytochrome p450 3A4 isoform (CYP 3A4), including some antifungal agents, protease inhibitors, and certain antibiotics.
According to the FDA, mixing ergotamine-containing agents with CYP 3A4 inhibitors can lead to serious, life-threatening ischemia, including gangrene and death. Most of the unapproved versions of the drug don't carry this warning, the agency noted.
The letters give the companies 15 days to respond to the FDA with a description of their action plans, 60 days to stop manufacturing the drugs, and 180 days to stop manufacturing them, or face sanctions.
"This action is the next step in an aggressive FDA initiative to insure that all marketed U.S. drugs have FDA approval," said Michael Levy, of the FDA's Center for Drug Evaluation and Research, in a briefing.
The approved products that will remain on the market are:
"We are taking a sensible, risk-based approach to the problem, and remain dedicated to the goal of getting unapproved drugs off the market," said Deborah M. Autor, CDER's director of compliance. "Doctors and patients often do not realize that not all drugs that are available on the market are backed by FDA approval. We estimate that less than 2% of prescribed drugs are unapproved."
The companies ordered to pull their products from the market are welcome to present data to the agency proving that their products are safe and effective, at which point they can be considered for approval, Autor said in the briefing.
The following companies have received the warning letters.