Excedrin Migraine Marketing Draws Criticism
from Advocacy Group
  

By Deborah Mitchell

WESTPORT, May 28 (Reuters) - In a new ad campaign for Excedrin Migraine, which recently received OTC marketing approval from the FDA, Bristol-Myers Squibb is not conforming to FDA guidelines for the appropriate use of the drug, according to a statement issued by the Migraine Awareness Group: a National Understanding for Migraineurs (MAGNUM).

Specifically, the migraine patient advocacy group believes that although the package insert states that Excedrin Migraine is approved for the treatment of mild-to-moderate migraine pain, and that a physician should be consulted if headache pain worsens or if unexpected symptoms occur, the company's television and print advertisements do not make this clear.

"MAGNUM is concerned that the current version of the Excedrin Migraine campaign, which omits the FDA statement regarding proper use of Excedrin Migraine, may inadvertently jeopardize both the short- and long-term health of migraine suffers who overmedicate or fail to seek proper medical treatment due to the marketing of and the over-the-counter availability of Excedrin Migraine," Terri Miller Burchfield, MAGNUM executive vice president explained.

However, Bristol-Myers Squibb is standing by their current advertising campaign. "We believe that the Excedrin Migraine advertising campaign is very clear and very informative," Bristol-Myers Squibb spokesperson Nancy Goldfarb told Reuters Health. "We offer an 800 number and a website address so that headache sufferers can receive additional information."

One concern of the MAGNUM group is the potential for developing rebound headache, which may be triggered by the overuse of pain medication, Executive Director Michael John Coleman told Reuters Health. Instead of seeing a physician, migraine patients may increase Excedrin Migraine dosage if pain is not adequately relieved and this may lead to the onset of rebound headache.

"It is our intention to work with the various players involved with the Excedrin Migraine campaign to see that the ads follow the FDA position set forth in the January Talk Paper," Coleman continued in the press release. The organization "commends" Bristol-Myers Squibb for drawing attention to the needs of migraineurs, but hopes the ads will be modified to better reflect FDA guidelines, which the company helped develop.

"The FDA has no jurisdiction over advertising," Nancy Goldfarb countered. "So I think there's some misinformation here that MAGNUM is operating under...The "Talk Paper" was issued simply to clarify FDA's decision to have this product be packaged separately from the Excedrin Extra Strength, which had been on the market for over 20 years, as a way to eliminate any confusion as to why Bristol-Myers Squibb was introducing Excedrin Migraine as basically a new product."

Excedrin Migraine contains 250 mg acetaminophen, 250 mg aspirin and 65 mg caffeine per tablet, the same formulation contained in Extra Strength Excedrin. The Excedrin Migraine product comes with specific instructions and warnings for use in treating mild-to-moderate migraine pain. -Westport Newsroom 203 319 2700

© Reuters Wire Service 1998

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