FDA Pulls 15 Migraine Drugs off Market

Agency's Order Affects 'Unapproved' Drugs Containing Ergotamine

By Miranda Hitti
WebMD Medical News

Reviewed By Louise Chang, MD
on Thursday, March 01, 2007

March 1, 2007 -- The FDA today announced that it has ordered 15 unapproved migraine drugs containing ergotamine off the market.

Those drugs, sold only by prescription, lack a required "black box" safety warning and haven't been reviewed by the FDA for safety and efficacy.

The unapproved ergotamine drugs are unrelated to migraine drugs called triptans such as Imitrex, Zomig, and Maxalt.

The FDA's action also doesn't affect the five FDA-approved ergotamine drugs, which are:

• Migergot suppository (marketed by G and W Labs)
• Ergotamine Tartrate and Caffeine tablets (marketed by Mikart and West Ward)
• Cafergot tablets (marketed by Sandoz)
• Ergomar Sublingual tablets (marketed by Rosedale Therapeutics)

It can be hard for patients to identify the 15 unapproved drugs, "particularly because doctors prescribe them and might not know they are unapproved," FDA spokeswoman Sandy Walsh tells WebMD in an email interview.

"The best thing to do is educate yourself about what you are taking, see if the product contains ergotamine, and ask your doctor or pharmacist if you have questions," Walsh says.

She notes that many of the 15 unapproved drugs "have been around a long time and never got FDA approval."

'Black Box' Warning Missing

"The biggest concern is the absence of the 'black box' warning" on the 15 unapproved ergotamine drugs, the FDA's Deborah Autor said in a news conference.

"But we have concerns, more broadly, about the safety of all unapproved drugs," says Autor, who directs the Office of Compliance at the FDA's Center for Drug Evaluation and Research.

The "black box" warning for FDA-approved ergotamine drugs warns patients not to use such drugs if they are also taking certain medications that block an enzyme needed to break down and remove ergotamine from the body.

Autor says that though the FDA hadn't checked its records of adverse events reported with the 15 unapproved ergotamine drugs, "it's clear to us that there's an obvious risk from the absence of the [black box] warning."

The FDA sent warning letters to 20 companies about the 15 unapproved ergotamine drugs. Those companies include eight firms that make the drugs and 12 that distribute the drugs.

Those letters, dated Feb. 26, warn the companies that they have 15 days to respond to the FDA, 60 days to stop making the drugs, and 180 days to get the drugs off the market.

The companies receiving the warning letters can seek FDA approval for the ergotamine drugs, but until they get such approval, "they need to stop manufacturing and distributing these drugs," Autor says.

SOURCES: News release, FDA. Sandy Walsh, FDA spokeswoman. Deborah Autor, director, Office of Compliance, Center for Drug Evaluation and Research, FDA.

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