Botulinum Toxin Safety

What did FDA (Food and Drug Administration) state regarding botulinum toxin safety?

The FDA announced on April 30, 2009, that a boxed warning ("black box warning") must be added to the labeling of botulinum toxin products (Botox, Dysport, Myobloc) and a medication guide will be distributed to patients receiving these products for any use. Read the FDA News regarding botulinum toxin warning.

What is botulinum toxin?

Botulinum toxin is a substance produced by a type of bacteria. A person can become extremely ill if they accidentally eat food contaminated with this toxin. Fortunately, this rarely occurs in the U.S.

In the 1950s, medical researchers found that injecting overactive muscles with very small quantities of botulinum toxin resulted in a decrease of muscle activity and tone for 3 to 4 months. This research finding was put to practical use for the treatment of several medical problems. Purified forms of botulinum toxin became commercially available in 1989 for the treatment of medical conditions related to overactive muscles, including strabismus ("crossed eyes"), blepharospasm, and hemifacial spasm.

The Botox brand of botulinum toxin is most widely known for its use in cosmetic dermatology. In 2002, the FDA announced the approval of Botox to temporarily improve the appearance of moderate-to-severe frown lines between the eyebrows ("glabellar lines"). When used for cosmetic dermatologic purposes, botulinum toxin is injected in very small amounts into specific facial muscles blocking the muscle's impulse, weakening the muscle and diminishing the appearance of unwanted wrinkles and lines. As of 2007, Botox injection was performed more than 4.5 million times, making it the most common cosmetic operation in the U.S.

There are now 3 brands of botulinum toxin available in the U.S.; Botox (botulinum toxin type A), Myobloc (botulinum toxin type B) and Dysport (botulinum toxin type A).

Different brands have been used for a wide variety of medical uses beyond wrinkles, including cervical dystonia (spasms of the neck muscles), hyperhidrosis (excessive sweating), spasticity, and headache. Some of these uses are considered "off-label", meaning that they have not been formally approved by the FDA for those purposes.

Will botulinum toxin remain available for dermatologic use?

Yes. The warnings simply require the manufacturers to revised the information that is presented regarding their botulinum products and additional efforts will be made to share these risks with people seeking treatment with botulinum toxin.

Why did the FDA add a "black box" warning to botulinum toxin products?

The FDA added a warning to botulinum toxin products because of several cases when the botulinum toxin spread beyond the injection site resulting in serious side effects. Symptoms included difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression.

These serious side effects occurred primarily in children being treated for muscle spasms due to cerebral palsy, and in adults being treated for spasms or cervical dystonia. In these cases, botulinum toxin is often injected in large doses, or into the muscles of the neck.

It is important to note that the FDA reports that no serious side effects have been reported from the dermatologic use of botulinum toxin products when used as approved by the FDA.

Does this warning apply to all brands of botulinum toxin?

Yes. All brands of botulinum toxin will be required to share information about the risks.

Before receiving a treatment with botulinum toxin products, what issues should someone consider?

The American Academy of Dermatology (AAD) recommends that patients do their homework and consider the training and credentials of the person providing treatment before they decide if botulinum toxin products are right for them.

It is important to ask the following:

  • Is the treatment being performed by a physician experienced in this procedure?
  • What results can be expected?
  • How long is the recuperation period?
  • What are the risks?
  • Where is the procedure usually performed?
  • What is the cost?

Are there any side effects that occur normally following the use of botulinum toxin products?

Minimal, temporary and reversible side effects following the use of botulinum toxin products may include:

  • Soreness or mild bruising around the injection site.
  • A temporary headache after injections in the forehead area, especially after the first treatment.
  • In rare instances, weakness of the neighboring muscles leading to a temporary droopy brow or eyelid.

©2009 Vivacare Inc. All rights reserved. Vivacare.
Last updated November 10, 2009.

This information is for general educational uses only. It may not apply to you and your specific medical needs. This information should not be used in place of a visit, call, consultation with or the advice of your physician or health care professional. Communicate promptly with your physician or other health care professional with any health-related questions or concerns.

Be sure to follow specific instructions given to you by your physician or health care professional.