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Botox Gets Black Box Warning

By Denise Mann; reviewed by Peter Fodor, MD, FACS

The Food and Drug Administration (FDA) now requires black box labeling on Botox and similar products to warn of a rare, but potentially life-threatening complication if the toxin spreads beyond the injection site. A black box warning is the strongest issued by the FDA.

The FDA conducted their investigation after the Washington, D.C.-based consumer watchdog group Public Citizen reviewed FDA data and found that the agency had received reports of 180 U.S. cases of people developing various conditions (sometimes life-threatening), including respiratory failure, after receiving Botox injections (botulinum Types A and B).

Most of the hospitalizations and deaths occurred in children with cerebral palsy who are treated with botulinum toxin for muscle spasms; however, some serious hospitalizations have been reported in adults treated with botulinum toxin for involuntary muscle movement and frequent neck spasms.

If you have already received Botox injections or are considering Botox injections for cosmetic reasons, here's what you need to know now:

What did the FDA decide?

The FDA now requires a boxed warning, a letter to doctors and a medication guide to be handed to people who receive Botox injections. All of these warn about the potential for the product to spread and cause swallowing and breathing problems.

The manufacturers of Botox products must also follow a group of children and adults using Botox, Myobloc, or Dysport off-label to treat involuntary muscle movement and submit theur safety data to the agency for review. The FDA also states that manufacturers must warn consumers that Botox products cannot — and should not — be used interchangeably.

What products does this decision affect?

The FDA action affects Botox and Botox Cosmetic, both sold by Allergan Inc.; Myobloc, sold by Solstice Neuroscience; and a Dysport (marketed by Ipsen), which was just approved by the FDA.

Did any of the reported adverse effects occur in people using Botox to reduce fine lines and wrinkles?

No. The most serious adverse events occurred mainly among children with cerebral palsy who were treated for spasticity of their limbs. This is not currently an FDA-approved use of Botox injections in either adults or children. Still, the warning applies to both therapeutic and cosmetic forms of botulinum toxin. The FDA stated that cosmetic use of these products appears to be safe.

Were the Botox injections defective or tainted?

No. No evidence exists that the Botox products were defective in any way. The FDA stated that these adverse effects may have been related to overdosing. According to some reports, these children may have been receiving a dose up to 28 times greater than the amount injected into cosmetic Botox users.

How did the Botox injection in the limbs affect these children's lungs?

The active ingredient in Botox, botulinum toxin Types A and B, may spread from distant parts of the body to the muscles that affect breathing. This is reflected in current product labeling.

Is Botox safe?

Yes. Very. According to both the American Society for Aesthetic Plastic Surgery (ASAPS) and its sister organization, the American Society of Plastic Surgeons (ASPS), Botox is extremely safe. More than one million people have received Botox injections. Year after year, Botox ranks number one among nonsurgical cosmetic procedures among both men and women. Complications are rare; the most common side effects include bruising and numbness at the injection site, headache, nausea and flu-like symptoms.

How can I ensure that I am safe if I decide to receive Botox injections?

Step 1. Do your research. ASAPS suggests asking your doctor the following questions before you receive Botox injections:

  • What is your board certification? (Doctors certified in either plastic surgery or dermatology are most qualified to give Botox injections.)
  • How were you trained to do injectable treatments?
  • Do you regularly provide Botox treatments?
  • How many people have you treated who have a condition similar to mine?
  • Will you personally inject me? If not, what are the qualifications of the person who will?

Step 2. Be alert to signs and symptoms of serious problems. Although serious complications from Botox are extremely rare, their warning signs including worsening or unexpected difficulty swallowing, slurred speech, trouble breathing or muscle weakness. Seek medical attention if any of these symptoms occur. These effects have been reported as early as one day and as late as several weeks after Botox injections.

Are other injectables safe?

The new investigation concerns only Botox. It does not relate to — or affect — other available injectables on the market or in the pipeline. Each injectable has its own benefit and safety profile. Talk to your doctor about which one is right for your needs.

What is Botox?

Botox is produced from the bacterium Clostridium botulinum, which is commonly associated with food poisoning. In small, diluted amounts, however, Botox can be injected directly into specific muscles, causing a controlled weakening. It has cosmetic and medical uses.

Are there different types of Botox?

Yes. Botox Cosmetic, Botox and Dysport are both derived from botulinum toxin Type A, and Myobloc is derived from botulinum Type B. Another type of Botox may be available someday soon.

What are the approved — and unapproved — uses of Botox injections?

In April 2002, the FDA approved Botox Cosmetic for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines), but often it is used off-label on crows' feet, forehead creases and bands on the neck. Botox is also approved for spasm of the eyelids (blepharospasm), severe neck muscle spasms (cervical dystonia), excessive sweating (severe primary axillary hyperhydrosis), migraine headache, overactive bladder, urinary incontinence that stems from nerve damage caused by multiple sclerosis and spine injury. Myobloc is approved for the treatment of adults with cervical dystonia; it has not been tested sufficiently in children with this condition. Dysport is now approved to treat forehead wrinkles and frown lines. Currently Botox is being studied to determine if it might be useful in treating knee and hip osteoarthritis, temporomandibular joint disorder (TMJ), benign prostatic hyperplasia (BPH) and other conditions.

What is off-label use?

Off-label use refers to the somewhat common practice in which doctors use an approved medication for a reason that has doesn't have FDA approval. This practice can be both legal and ethical in many situations.

How does Botox affect wrinkles?

Certain wrinkles are created when nerve cells within the skin's muscles release a chemical called acetylcholine. Acetylcholine, in turn, triggers muscle contractions that create wrinkles. Botox blocks the release of acetylcholine, which paralyzes the muscle, stopping the contraction and erasing the wrinkle.

How long do the effects of Botox last on wrinkles?

Typically the effect of Botox injections on wrinkles lasts three to six months. [For more information, read our complete article on Botox.]

About the Reviewer of This Article

Peter Bela Fodor, MD, FACS, of Los Angeles, is an internationally recognized leader in the field of aesthetic plastic surgery and is highly respected by the profession as a surgeon, teacher and author. Dr. Fodor is associate clinical professor of plastic surgery at UCLA Medical Center. He lectures and performs live surgical demonstrations nationally and internationally.

After graduating from the University of Wisconsin Medical School, Dr. Peter Fodor completed his general surgery residency at New York's Columbia University and his plastic surgery residency at St. Luke's – Roosevelt Hospital. Dr. Fodor maintains hospital staff privileges at UCLA Medical Center, Century City Doctors Hospital and Olympia Hospital, all in Los Angeles, as well as at St. John's Hospital in Santa Monica, Calif. He is board-certified by both the American Board of Surgery and the American Board of Plastic Surgery.

FDA statement, April 30, 2009
The American Society of Plastic Surgeons. ASPS addresses concerns regarding Botox treatments. Press release, 1/25/2008.
The American Society for Aesthetic Plastic Surgery. The American Society for Aesthetic Plastic Surgery addresses the safety of botox. Press release. 1/25/2008.
FDA. Early communication about an ongoing safety review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). 2/8/2008.