FDA CITES 20 COMPANIES FOR MARKETING UNAPPROVED DRUGS
The FDA ordered 20 companies to stop manufacturing unapproved drug products containing ergotamine tartrate as part of the agency's safety efforts to keep unapproved drugs off the market.
Eight manufacturers and 12 distributors received warning letters, which the FDA posted to its website March 1. Ergotamine tartrate products are used to treat vascular headaches such as migraines and cluster headaches, the FDA added.
The companies have 60 days to stop manufacturing their unapproved products and 180 days to stop distribution, the agency said. The unapproved ergotamine products are sold as prescription drugs, Michael Levy, director of CDER's Division of New Drugs, said March 1.
The action does not affect five FDA-approved products containing ergotamine, which will remain on the market, Levy added.
The agency's main concern with the unapproved products is that they lack important risk information on their labeling, Deborah Autor, director of CDER's Office of Compliance, said. Ergotamine products used with CYP 3A4 inhibitors, such as some antifungal agents, protease inhibitors and some antibiotics, can cause gangrene or death, the FDA said.
The approved ergotamine products contain black-box warnings communicating that risk, the agency added. "It's clear to us that there's an obvious risk from the absence of a warning," Autor said.
The agency's action was the latest in an agency crackdown on unapproved drugs. "The FDA is moving forward expeditiously against unapproved drugs," Levy said. He added that unapproved drugs represent "a significant public health concern."
Last year, the agency released a compliance policy guidance detailing its enforcement approach to the marketing of unapproved drugs. Most recently, the FDA issued warnings to several manufacturers of unapproved quinine products.
The warning letters can be seen at www.fda.gov/cder/drug/unapproved%5Fdrugs/ergotamine_WL.htm ( http://www.fda.gov/cder/drug/unapproved%5Fdrugs/ergotamine_WL.htm ).