Serious Botox Side Effects — Including Botulism — More Common Than Reported, Health Advocates Say

A consumer advocacy group wants stronger warnings on Botox and similar injectables, asserting that the number of people experiencing serious side effects is higher than reported.

In a petition filed Tuesday to the U.S. Food and Drug Administration, Washington D.C.-based consumer advocacy group Public Citizen requested that the agency write a stronger warning about the potential risks of Botox and other injectable drugs such as Daxxify, Jeuveau, Myobloc, Dysport and Xeomin. 

The injectables, which use variations of botulinum toxins to get rid of wrinkles, already have a “black box” warning due to a potential — but very low — risk of life-threatening side effects that may occur if the toxin spreads to other areas of the body, an event called iatrogenic botulism. 

The group analyzed the FDA’s Adverse Event Reporting System (FAERS) data, a total of 5,414 incidents reported into an online system by doctors and patients themselves, from January 1998 to March 2021. There were 511 deaths, 1,652 hospitalizations and 222 life threatening reactions. Although the numbers are small, health advocates say there may be many more cases that go unreported.

“The FDA gets 10% of the cases of adverse events because there's a lot of under-reporting going on,” Azza AbuDagga, Ph.D., health services researcher at Public Citizen, tells The Messenger.

The group says in its petition the current warning is misleading, arguing “it waters down and obscures this serious risk by limiting its wording to the ‘distant spread of toxin’ euphemism.” 

The current warning mentions “serious symptoms including loss of strength and all-over muscle weakness; double vision; blurred vision; drooping eyelids; hoarseness or change or loss of voice; trouble saying words clearly; loss of bladder control; trouble breathing; and trouble swallowing.” 

But, Dr. AbuDagga says, it doesn’t go far enough. “We found cases, people actually received the product and they were okay, but later they were injected with normal doses, and they developed botulism or botulism-like symptoms.

“The box warning doesn't mention that the risk of botulism or cases of iatrogenic botulism have happened with initial injections and as well as repeated injections,” Dr. AbuDagga says. “So it could happen to people who have used the products for years."

In 2008, Public Citizen successfully petitioned the FDA to require the current black box warning.

Now, in addition to stronger language in the warning, the group seeks the removal of “misleading” statements in the products’ promotional materials, including the statement that “No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX” for various conditions at the recommended dosages.

Reuters reports that the FDA will review the group’s petition and respond directly to Public Citizen. Merz, which makes Xeomin, told the outlet that it tracks the adverse events database and files regular safety reports to the FDA. 

The makers of Botox, Daxxify, Jeuveau, Myobloc, Dysport and Xeomin have not responded to The Messenger’s request for comment.

According to the American Society of Plastic Surgeons’s latest figures, people spend $2 billion a year on Botox, with some 4.4 billion Botox procedures annually as of 2020. 

Dr. Jason Diamond, a Beverly Hills plastic surgeon and facial specialist, previously told The Messenger that Botox and fillers “are still medical procedures” that should only be performed by a board certified facial plastic surgeon.

“It is my belief that the more highly trained and more highly knowledgeable a provider is,” he said, “the safer you are. Make no mistake. It’s still medicine.”