Last year, the FDA increased the labeling requirement on botulinum toxin products distributed under the names Botox, Dysport, and Myobloc. These substances are used to treat many medical conditions including involuntary muscle spasms disorders. The move to add a “black box” warning to Botox and related drugs was made in response to a number of reported deaths and life threatening reactions requiring hospitalization for breathing problems.
Many of the deaths reported were in children with cerebral palsy. A significant number of adults treated for cervical dystonia (spasms in the neck and shoulder) were among those hospitalized. Heart and lung complications occurred in adult and pediatric patients who were being treated with relatively high doses of the toxin for therapeutic purposes. When the injected medication spread too far from the intended area, it caused botulinum poisoning with severe side effects.
What’s In the Box?
A Black Box label is intended to notify patients and physicians about the risk of adverse side effects when using products containing Botulinum Toxin Type A. This warning is prominently displayed on informational materials and packaging. The FDA requires this type of labeling when a product has been directly linked to a serious complication. It is not an indication that these life threatening reactions are common – they actually appear to be quite rare. Manufacturers of these products have been instructed by the FDA to perform additional safety studies to discover the full extent of risks.
The informational material in the Botox black box label lets patients know that they should seek emergency medical attention if they have difficulty breathing or swallowing. Other indications that a serious side effect is occurring include chest or abdominal pain, nausea, vomiting, hives, swelling of the face or tongue, and heart palpitations.
What about Cosmetic Use?
The FDA has instituted the black box warning for both Botox (the kind used for treating medical conditions) and Botox Cosmetic (the type used by dermatologists for treating facial wrinkles). This is because both products have the same active ingredient. There have been no reports of life threatening side effects in patients who are injected with Botox for cosmetic purposes. The doses used are typically quite small and are not injected into areas where major organ function is likely to be affected.
Individuals who have a history of allergic reaction to botulinum toxin should not receive injections of the substance even for cosmetic purposes. Otherwise, patients who are in good health and receiving cosmetic Botox or Dysport injections from a board certified dermatologist are not currently considered to be at risk for life threatening side effects.
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About the Author:
After graduating Kent State University with summa cum laude honors and finishing in the top ten percent of his graduating medical school class, he performed his preliminary internal medicine internship at Emory University/Grady Memorial Hospital in Atlanta, Georgia. He then completed his three year dermatology training at the University of Texas Southwestern Medical Center in Dallas, Texas. Since moving out to California in July 2005, he has worked with the Cedars-Sinai Medical Group and in private practice. He currently is on staff at Cedars-Sinai Medical Center, Glendale Adventist Medical Center, Glendale Memorial Hospital, and Providence Tarzana Medical Center. Dr. Mehrabi enjoys all aspects of dermatology, including medical / general dermatology, pediatric dermatology, cosmetic dermatology, surgical dermatology, and laser dermatology. His particular interests include Botox, dermal fillers, Mohs surgery, and laser dermatology. He is very proud to be able to offer all of these services in Beverly Hills, Encino/Tarzana, and Glendale.