FDA Takes Action to Cease Distribution of Illegal Drugs

The Food and Drug Administration (FDA) told 20 companies to cease marketing unapproved drug products containing ergotamine tartrate. Ergotamine tartrate products are used to treat vascular headaches, including migraines. As part of the FDA’s continued efforts to combat the marketing of unapproved drugs, the agency sent warning letters to eight manufacturers and 12 distributors warning them that they are subject to further enforcement action if they do not stop manufacturing and distributing these products.

The agency urges consumers who are using ergotamine products and have questions or concerns to contact their health care provider. This action does not affect FDA-approved products containing ergotamine, which will remain on the market.

“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 (CDER). “Because they have not been subject to FDA review, the safety, effectiveness, and quality of such products are unknown.  We remain dedicated to tackling this problem through education and outreach, as well as enforcement actions like these.  It is central to our mission to ensure a safe and effective drug supply for the American public.”