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FDA panel suggests over-the-counter migraine medication
July 22, 1997
Web posted at: 8:48 p.m. EDT (0048 GMT)WASHINGTON (CNN) -- A Food and Drug Administration advisory panel is recommending that Extra Strength Excedrin be labeled as a treatment for migraine headaches. If approved by the FDA, it would become the first over-the-counter pain relief labeled as a migraine treatment.
It is estimated 10 to 20 million Americans suffer from migraine headaches, three-fourths of them women.
Extra Strength Excedrin contains acetamenophin, aspirin, and caffeine as active ingredients. It's currently indicated for temporary relief of the pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache and minor arthritis pain, according to the Physician's Desk Reference.
"I think that the three studies they presented certainly did show efficacy in mild to moderate migraine," said Dr. Seymour Diamond, a consultant for the committee.
Extra Strength Excedrin -- made by Bristol-Myers Squib Company -- is not the only over the counter pain reliever containing this combination of active ingredients. For example, a product called Vanquish contains the same active ingredients.
Rebecca Burkholder of the National Consumers League, said, "The label will clearly instruct consumers to consult a doctor before use if the migraine is accompanied by vomiting or if it is so severe, bed rest is required."
The committee said Bristol Myers should do more studies to make sure people don't overuse Extra Strength Excedrin.
A migraine is a recurrent throbbing headache that typically causes pain on one side of the head. It is often accompanied by nausea, vomiting and sensitivity to light and noise. It can last from two hours to two days. Migraines are believed to be caused by constriction and then dilation of the blood vessels in the brain.
Remedies range from regular aspirin to prescription drugs that constrict swollen blood vessels.
An Emory University neurologist who treats migraine patients, Dr. Sarah DeRossett, told CNN that Extra Strength Excedrin is indicated for mild attacks, though it is not very effective.
It is up to the FDA to accept or reject it the recommendation. Generally, the FDA accepts recommendations from the advisory panels.
CNN reporter Eugenia Halsey contributed to this report.
Related story:
- Promising new migraine treatment may ease suffering - July 24, 1996
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