THE OTHER FACE OF BOTOX

The Medical Letter Reports Wrinkles in the Botox® Cosmetic Panacea
or
The Medical Letter Reviews Botox® Cosmetic for Frown Lines

NEW ROCHELLE, NY -- May 28, 2002 -- Botox® Cosmetic (botulinum toxin Type A), was recently FDA approved for removing facial wrinkles. Botulinum toxin is a purified form of one of the most potent toxins in the world, and while effective to temporarily decrease wrinkles, it may not be as safe as its users believe. There are also no studies on its long-term effects.

According to the May 27, 2002 issue of The Medical Letter on Drugs and Therapeutics, a leading provider of unbiased and comprehensive evaluations of new drugs, while Botox can temporarily reduce or remove frown lines, it can also cause eyelid or eyebrow drooping, double vision, reduced blinking and corneal ulceration. The most frequently reported adverse effects in clinical studies for treatment of forehead frown lines were headache, respiratory infection, nausea and flu-like syndrome. These effects are usually transient, but may last several months.

"With heavy advertising and the allure of nonsurgical wrinkle removal in minutes, consumers are asking dermatologists for this seemingly simple anti-aging solution," said Gianna Zuccotti, M.D., M.P.H., Deputy Editor of The Medical Letter. "Physicians should caution patients about the possible adverse effects of this treatment, and the fact that there are no long-term studies." The American Academy of Dermatology urges patients to select a qualified dermatologist and have the procedure performed in an appropriate setting.

The local injection-site effects of Botox can include facial pain, erythema (redness), edema and ecchymosis (purplish bruise). Weakness of muscles near the injection site may occur if the drug spreads in the tissues and some degree of facial expression may by lost. Another reported effect of forehead injections is severe, intractable headaches lasting for two to four weeks.

Complications are more common when Botox is used in the lower face,
reports The Medical Letter. They include drooling, an asymmetrical smile and repeatedly biting the inside of a flaccid cheek. With injections into the platysma muscle, dysphagia and changes in vocal pitch can occur. Long-term use can cause reversible denervation atrophy in the injected muscles. The lethal dose of Botox in humans is unknown.

For drug evaluations, The Medical Letter carefully examines published and available unpublished studies as well as any material supplied by the manufacturer. A preliminary report of this material is reviewed by The Medical Letter's Editorial Board, other investigators who have special clinical and experimental experience with the drug or type of drug, the pharmaceutical company, and sometimes companies that make competitive drugs.

About The Medical Letter
The Medical Letter Inc., a nonprofit organization founded in 1958, offers health care professionals objective, independent analysis of new drugs. In addition to its biweekly newsletter, The Medical Letter on Drugs and Therapeutics, it also publishes handbooks and software on topics such as adverse drug interactions and antimicrobial therapy. The Medical Letter is supported entirely by subscriber fees and is based in New Rochelle, NY. For more information about The Medical Letter call (800) 211-2769 or visit their Web site at www.medicalletter.org.