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"She was just incredulous," Evans says. "She just didn't understand how a drug for headaches could cause headaches." But 10 days after she quit, the frequency of the woman's headaches decreased dramatically, he writes. "Virtually all medications used to treat headache can become a cause of headache if overused," says Richard Lipton, a neurologist from Montefiore Medical Center in New York who was a consultant to Bristol-Myers Squibb in the development of Excedrin Migraine. For reasons that aren't clear, "I think migraine sufferers have a particular vulnerability," Lipton says. In January 1998, Excedrin Migraine became the first non-prescription drug approved to treat mild to moderate migraine pain. It contains the same ingredients as Excedrin Extra Strength: 250 milligrams of acetaminophen, 250 milligrams of aspirin and 65 milligrams of caffeine. But only Excedrin Migraine bears instructions and warnings related to treating a migraine. This month, the Food and Drug Administration approved marketing Excedrin Migraine for the treatment of all migraine-related symptoms, including nausea, sensitivity to light and sound, and difficulty performing activities. A revised label accompanies the expanded indication. Both original and new labels warn consumers to see a doctor if they have daily headaches. The old label warns migraine sufferers against taking the drug for more than 48 hours. The new label makes no mention of a time limit. It simply says to take two tablets and to see a doctor if symptoms persist or worsen. That's inadequate, Evans says. "Rebound is not a rare side effect. Why not list this as a potential side effect?" But many doctors, let alone consumers, aren't familiar with rebound headache, Lipton says. "You can't put on the label 'Overuse causes rebound headache,' " he says. "Who knows what overuse is? Who knows what a rebound headache is?" In a letter to Evans, Howard Hoffman, Bristol-Myers Squibb's executive medical director, says that following dosing instructions and warnings, especially about daily headaches, is enough to prevent rebound. © 1999 USA Today |
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