You've probably seen television commercials or print advertisements for many over-the-counter headache and migraine relief medications. On our forums, we've discussed that Excedrin Migraine has the same ingredients as Extra Strength Excedrin, but some stores are charging more for Excedrin Migraine.
In a recent article in Headache: The Journal of Head and Face Pain, Doctors Fred Sheftell, David Dodick, and Roger Cady expressed concerns that reach far beyond the price in dollars and cents.1
These doctors, all acknowledged experts in the field of headache and migraine treatment, are concerned "for the risk to public safety posed by direct-to-consumer advertising (DTC) of over-the counter (OTC) medications." They point out that advertising for prescription medications is regulated by the Food and Drug Administration (FDA), and advertising for OTC medications is regulated by the Federal Trade Commission (FTC). The standards imposed on prescription medications are more stringent than those for OTC medications.
Think about it. When you see an advertisement for prescription medications, it not only points out the beneficial effects of the medication, it also states contraindications and warnings. OTC advertising, however, generally presents only information on the beneficial effects of the medication, seldom mentioning contraindications or safety information. The FDA requires advertising to maintain a "fair balance," speaking to safety as well as efficacy. The FTC has no such requirement. Sheftell, Dodick, and Cady state:
"This regulatory dichotomy places the consumer in a vulnerable position and at risk for potentially serious adverse health effects. Patients often do not report their use of OTC products to either the pharmacist or physician, leaving them susceptible to misuse, overuse, and potentially dangerous drug interactions with other OTC and prescribed products."2
They also raise the point that OTC medications are no longer really "over-the-counter." Over-the-counter originally referred to purchasing nonprescription medications from their pharmacist who dispensed them "over the counter," and had the opportunity to offer advice and education such as we are offered today when we purchase prescription medications. One of the authors coined the term "off-the-shelf" (OTS) as a more accurate term for what we now call "over-the-counter."
These doctors are not saying that there is no place for nonprescription medications in the treatment of headache and migraine. They are saying that these products will be of more benefit when used as intended, safely, and "with full public disclosure of their benefits and risks."
To summarize their points, Doctors Sheftell, Dodick, and Cady quote from another article by Dr. Sheftell:3
"In summary, the key educational take-home message to the patient should include the following points:
1. All OTS analgesics are potentially
effective,
2. all have a wide margin of safety, but
3. be aware of side effects,
4. be aware of the consequences of inappropriate use,
5. READ THE LABEL!,
6. check with their physician and/or pharmacist in regard to potential
interactions with other medications and other comorbid disorders and finally,
7. be responsible and remember nonprescription medication is medication!"
OTC's have their place in the treatment of headache and migraine, just as prescription medications do. If you follow Dr. Sheftell's seven points, you'll derive the maximum benefit with the minimal risk.
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References:
1
Sheftell, Fred, Dodick, David & Cady, Roger (2001)
Direct-to-Consumer Advertising of OTC Agents Under Current FTC Regulations:
Concerns and Comment.
Headache: The Journal of Head and Face Pain 41 (6), 534-536.
2 Horn J. Pharmacology of over-the-counter analgesics used for the treatment of headache. Headache. 1994;34(suppl 1):6-9.
3
Sheftell FD. Role and impact of over-the-counter
medications in the management of headache. Neurol Clin. 1997;15:187-198
