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U.S. Department of Health and Human Services

Safety

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Ergotamine tartrate March 2007

Audience: Pharmacists, other healthcare professionals, consumers

[Posted 03/02/2007] FDA informed healthcare professionals and consumers that the Agency ordered twenty firms to stop marketing unapproved drug products containing ergotamine tartrate. Ergotamine tartrate products are used to treat vascular headaches, including migraines. Unapproved drugs pose real risks to the American public because they have not been subject to FDA review, and the safety, effectiveness, and quality of such products are unknown. This action does not affect FDA-approved products containing ergotamine. Consumers who are using ergotamine products and have questions or concerns are urged to contact their health care provider.

[March 01, 2007 – News Release – FDA]
[March 01, 2007 – Warning Letters – FDA]