Defending Botox: Warnings not warranted, derms say

May 1, 2009

As the Food and Drug Administration (FDA) reviews the safety of therapeutic and cosmetic botulinum toxin injections, dermatologists say adding warnings to Botox Cosmetic (botulinum toxin A, Allergan) would be unwarranted.

Key Points

National report - As the Food and Drug Administration (FDA) reviews the safety of therapeutic and cosmetic botulinum toxin injections, dermatologists say adding warnings to Botox Cosmetic (botulinum toxin A, Allergan) would be unwarranted.

In a Jan. 23, 2008, petition to the FDA, the advocacy group Public Citizen called for "black box" warnings, warning letters for physicians and a medication guide for patients to heighten awareness of serious adverse events (AEs) that have occurred with botulinum toxin injections.

A total of 217 were reported with therapeutic botulinum toxin injections, and 36 with cosmetic use, between 1989 and May 2003.

In February 2008, the FDA acknowledged it was reviewing safety data from clinical studies submitted by the manufacturers of Botox and Myobloc (botulinum toxin B, Solstice), as well as post-marketing adverse event reports.

"FDA has received reports of systemic adverse reactions, including respiratory compromise and death, following the use of botulinum toxin types A and B for both FDA-approved and unapproved uses," this early communication states.

"The most serious cases have outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy (CP)-associated limb spasticity," which is an unapproved use in the United States.

Accordingly, Gennady Rubinstein, M.D., says that a "black box" warning for Botox's therapeutic indications might be appropriate.

But a similar warning for cosmetic applications is "not reasonable for a product as safe as Botox Cosmetic," he says. "There are millions of procedures done every year worldwide, and virtually no serious side effects, according to the FDA."

Dr. Rubinstein is clinical instructor, department of medicine (dermatology), University of California, Los Angeles, and director, Dermatology and Laser Center of Studio City, Calif.

Jean D. Carruthers, M.D., says children with CP-associated spasticity are too unwell to undergo general surgery to treat their spasticity.

"So, physicians have tried very hard to treat them less invasively," she says. In some cases, doctors use Botox doses up to 20 units/kg, "whereas in the cosmetic world, we're using somewhere between 1 and 3 units/kg."

Dr. Carruthers is clinical professor of ophthalmology, University of British Columbia, Vancouver.

Judith Hellman, M.D., says that in the forehead, glabella and face, "One would have to inject tremendous amounts (of Botox) - instead of the minute amounts we inject - in order to get a serious systemic complication."

But in the platysmal bands, "I could see if someone is not very careful and does not use very good technique, or injects too much, it's possible you could get spread to the muscles that control the esophagus," she says.