FDA
TALK PAPER
Food and Drug AdministrationU.S. Department of Health and Human Services
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T98-3 Susan M. Cruzan: 301-827-6242
Jan. 14, 1998 Broadcast Media: 301-827-3434
Consumer Inquiries: 800-532-4440
FDA Approves First OTC Drug for Relief of Migraine Pain
FDA has approved Excedrin Migraine -- the first over-the-counter medicine approved for treating pain associated with mild to moderate migraine headaches. Migraine headaches typically affect about 16 to 18 million people in this country. Although migraine headaches can include significant symptoms other than pain, this product is indicated only for treating pain associated with migraines. The following may be used to respond to inquiries.The product approved today contains 250 mg of acetaminophen, 250 mg of aspirin and 65 mg of caffeine per tablet. Caffeine, which is included in some approved combination prescription medicines for migraine, is an analgesic adjuvant for pain.
Three U.S. clinical studies involving more than 1,300 patients with acute migraine headaches demonstrated the safety and effectiveness of Excedrin Migraine for alleviating pain associated with mild to moderate migraine attacks within two to four hours of taking the medicine.
A two-tablet dose of Excedrin Migraine is recommended, taken at 6-hour intervals as needed. Although this combination of ingredients is the same as the currently marketed Excedrin Extra Strength product, Excedrin Migraine has important instructions and warnings for use in treating the pain of migraine.
Patients are advised to consult with their doctor before use of the new
Excedrin product if the headache is accompanied by vomiting, if the headache is
so severe as to require bed rest, and if symptoms continue or worsen, or new or
unexpected symptoms occur. Patients with migraine headaches not helped by the
new product may receive prescription drugs for controlling symptoms such as
ergot preparations (for example Cafergot), serotonin receptor agonists (for
example Imitrex, and other migraine drugs
such as Midrin and Depakote. Excedrin Migraine is made by Bristol-Myers Squibb,
Hillside, NJ.
Material on this page is for
informational purposes only,
and should not be construed as medical advice.
Always consult your physician regarding medications.
