The agency said it sent letters warning the companies that they are subject to further enforcement action if they do not stop manufacturing and distributing the migraine treatments which contain a drug called ergotamine tartrate. Letters went to companies such as Teva Pharmaceutical Industries, Actavis and Sandoz.
The FDA’s actions against unapproved drugs are part of the agency’s broader initiative to prevent unapproved drugs reaching consumers.
“We estimate that less than 2% of prescribed drugs are unapproved. This lack of approval undermines FDA’s drug safety efforts,” said Center for Drug Evaluation and Research’s director of Compliance, Deborah Autor.
In addition most of the companies have omitted from their drugs’ labeling critical warnings regarding the potential for serious, possibly fatal, interactions with certain other drugs.
Based on recent information, the five marketed, approved versions of ergotamine-containing products have updated their labeling to include the strongest agency warning against using such products when also taking potent CYP 3A4 inhibitors. Serious and life-threatening ischemia including death and gangrene, have resulted when such products are used together.
Companies have 15 days to respond to the FDA with a discontinuation plan for their products. Manufacturers have 60 days to cease manufacturing of new product, and distributors have 180 days to cease further shipment of existing products.