Petition Asks for Stronger Safety Warnings for Botox

The petition asks the U.S. Food and Drug Administration (FDA) to strengthen the "black box" warning for Botox and related products over botulism risk and remove misleading claims.

The petition by Public Citizen, a consumer advocacy group, says the labeling of cosmetic and therapeutic products containing botulinum toxin, such as Botox, should more clearly state the possible risk of iatrogenic botulism, even when used at recommended doses.

Iatrogenic botulism is a rare but severe complication of treatment with Botox and other medicines with botulinum toxin. The condition that occurs when the toxin spreads beyond the injection site may result in progressive, typically descending muscle paralysis or weakness.

"Our petition is based on clear postmarketing evidence that refutes industry propaganda claiming that Botox and related drugs are ‘always safe’ and that no 'definitive’ cases of botulism have occurred with recommended doses," said Azza AbuDagga, Ph.D., health services researcher at Public Citizen’s Health Research Group, in a statement.

The petition comes after the group identified 5,414 reports with serious outcomes from Botox and similar treatments, including hospitalization, disability, and death, between 1989 and March 2021.

As the cases were voluntarily reported through the FDA’s Adverse Event Reporting System (FAERS), the true extent of the risk may be underestimated, the group says.

The petition also asks the FDA to remove "misleading promotional statements" from Botox and Botox Cosmetic labeling, claiming that no definitive serious adverse events due to the distant spread of the toxin have occurred when using the drug in recommended doses.

The group seeks a more comprehensive warning on the label of six toxin-containing injections, including Botox, Daxxify, Jeuveau, Myobloc, Dysport, and Xeomin.

In 2009, the FDA strengthened the black-box warning on labeling of Botox and similar drugs over the risk of distant spread of the toxin, as required by the 2008 Public Citizen petition.

A poisonous drug

Botulinum toxin is one of the most poisonous biological substances known, produced by the bacterium Clostridium botulinum. The toxin causes a life-threatening type of food poisoning called botulism but is also used in medicine for the following health issues:

• Temporary smoothing of facial wrinkles
• Severe underarm sweating
• Cervical dystonia, a neurological disorder that causes severe neck and shoulder muscle contractions
• Blepharospasm, uncontrollable blinking
• Strabismus, misaligned eyes
• Chronic migraine
• Overactive bladder

Because the use of botulinum toxin may lead to life-threatening complications, it is crucial to seek treatment only from certified medical professionals.