Warning Letters Demand Stop to Unapproved Ergotamine Manufacture and Distribution

Rockville, MD (Mar. 1)-Sending Warning Letters to eight manufacturers and 12 distributors, the US Food and Drug Administration (www.fda.gov) ordered a stop to the manufacture and distribution of unapproved drug products containing ergotamine tartrate. The action does not affect FDA-approved products containing ergotamine. Most of the companies receiving the letters have omitted from their drugs’ labeling a critical warning regarding the potential for “serious, possibly fatal, interactions with certain other drugs,” including potent CYP 3A4 inhibitors, according to the agency.

“Unapproved drugs pose real risks to the American public,” said Steven Galson, MD, director of FDA’s Center for Drug Evaluation and Research, in a public statement. “It is central to our mission to ensure a safe and effective drug supply for the American public.”

FDA estimates that less than 2% of prescribed drugs on the market are unapproved and continues to combat the marketing of unapproved drugs through its Unapproved Drugs Initiative.