Botox: FDA Review Update

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

The Food and Drug Administration (FDA) is investigating rare reports of serious adverse events linked with Botox, Botox Cosmetic and Myobloc.

If you have already received Botox injections or are considering Botox injections for cosmetic reasons, here's what you need to know. The investigation is still in its infancy; this Q&A will be updated as new information becomes available.

Why is the FDA looking into the safety of Botox?

A Washington, D.C.-based consumer watchdog group called Public Citizen reviewed FDA data and found that the agency had received reports of 180 U.S. cases of people developing sometimes life-threatening conditions, including respiratory failure, after receiving Botox injections (botulinum Types A and B). Sixteen deaths had occurred, four of which were of children less than 18 years old. Public Citizen then filed a petition with the FDA calling for stronger and more widely disseminated warnings concerning these risks.

What sanctions is Public Citizen calling for?

Pubic Citizen is asking for a "black box" warning on Botox products. This is the strongest warning that the FDA can place on a product. The group also wants doctors to inform patients receiving Botox injections about the potential risks and alert them to possible warning signs of severe adverse reactions.

How are the Botox manufacturers responding to this investigation?

Allergan, the company that manufactures Botox and Botox Cosmetic, fully supports the investigation and is working with the FDA to ensure that it has all of the information needed for a thorough review. The company stands by the safety of its product.

"Since its approval, over a million people have been treated with Botox Cosmetic," said Sef Kurstjens, MD, chief medical officer for Allergan, in a written statement. "In its entire history, there has never been a single reported death where a causal link to Botox Cosmetic was established."

In addition, Solstice Neurosciences, the manufacturer of Myobloc, stated that it fully supports the FDA review of Botox and remains committed to providing the agency with any information it needs.

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.

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 and Botox 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. Already approved in more than 60 countries, Dysport/Reloxin, an injectable form of botulinum toxin Type A, is moving down the pike. Stay tuned.

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 approved for spasm of the eyelids (blepharospasm), severe neck muscle spasms (cervical dystonia) and excessive sweating (severe primary axillary hyperhydrosis). Myobloc is approved for the treatment of adults with cervical dystonia. (It has not been tested sufficiently in children with cervical dystonia.) Currently Botox is being studied to treat a laundry list of other conditions, from knee and hip osteoarthritis to migraine headache and benign prostatic hyperplasia (BPH).

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.]

Sources:
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.

[page updated June 2008]