FDA Pulls 15 Migraine Drugs off Market
Agency's Order Affects 'Unapproved' Drugs Containing Ergotamine
March 1, 2007 -- The FDA today announced that it has ordered 15 unapproved
migraine drugs containing ergotamine off the market.
These prescription drugs, though used to treat migraines, haven’t been
reviewed by the FDA for safety and efficacy.
This does not affect the most commonly prescribed migraine drugs called
triptans, such as Imitrex, Maxalt, and Zomig, which the FDA has deemed safe and
effective for the treatment of migraines.
The FDA's action also doesn't affect the five FDA-approved ergotamine drugs,
- Migergot suppository (marketed by G and W Labs)
- Ergotamine Tartrate and Caffeine tablets (marketed by Mikart and West
- 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
"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
"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.