Monday, March 05, 2007

unapproved ergotamines removed from market


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The FDA made an important announcement last week that it was pulling 15 migraine drugs from the market.

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.

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 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.


Please refer to the FDA announcement for more information:
FDA Takes Action to Halt Marketing of Unapproved Ergotamine Companies Ordered to Cease Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches

If you are taking a medication containing ergotamine that you are unsure about, please discuss the situation with your doctor.

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