Behind the Botox Alert
Many of my patients were concerned and called my office when they heard news reports that the U.S. Food and Drug Administration (FDA) said it was reviewing the safety of Botox, Botox Cosmetic, and Myobloc. Because Botox has become such a popular cosmetic treatment, often used to soften wrinkles in the face and forehead, I’d like to explain the basis for this investigation and how it might or might not affect you.
The FDA is reviewing cases of individuals treated with Botox between 1996 and 2007 who developed adverse reactions. While the inquiry relates primarily to children withcerebral palsy who were given Botox to relax severe muscle spasms in their legs, the FDA is considering all reports of harmful side effects. Although the use of botulinum toxin for cerebral palsy is not approved in the United States, doctors have prescribed this treatment as a successful alternative to painful surgery. This is therefore known as an “off label” use of Botox, which means that it’s used to treat a condition outside of the FDA-approved labeling for the drug. The FDA does permit physicians to use an approved medication off label, but urges doctors to be well informed about the drug, to use it based on firm scientific evidence, and to maintain records on the medication’s use and effects. Since the muscles in the legs are so much larger than the facial muscles that cause frown lines in your forehead and crow’s-feet around your eyes, it takes 20 to 100 times the amount of Botox used in a typical wrinkle treatment to treat leg spasms. It is possible for some of the Botox to seep out beyond the intended muscle group and cause a potentially life-threatening reaction, such as the weakening of respiratory and digestive muscles, which could lead to difficulty breathing and/or swallowing. Several children with cerebral palsy who were treated with Botox required feeding tubes and/or intubation to help them breathe.
While there are no new reports of adverse reactions related to the cosmetic use of Botox, there are possible side effects that can range in severity from dizziness to chest pain. But it’s important to know that there has never been a reported death attributed to Botox Cosmetic. As a dermatologist, I use Botox Cosmetic to treat patients who want to smooth out their facial wrinkles and frown lines, as well as to treat excessive perspiration. If used correctly, and in the appropriate doses, it’s very safe and effective. I have personally used Botox Cosmetic and have treated patients with it since 1996, so I hope this will reassure those of you who have used Botox for cosmetic reasons.
Nevertheless, this recent FDA alert is a reminder that Botox is still a medical procedure and should be performed by an experienced, board-certified dermatologist or plastic surgeon in a medical setting. While you may be tempted to get a “deal” at a spa or salon that offers discount Botox, the person doing your injection in this type of setting may not have much experience (you might be the first client!). As with any elective procedure, be sure to find out who will be doing your injections and how long the person has been using Botox. A good place to start is to ask your family physician or internist to recommend an experienced physician who can make sure this treatment is the right one for you.