- Public Citizen has petitioned the FDA for better warnings about Botox products
- Botox has been linked to a form of botulism, which can cause muscle paralysis
- READ MORE: A record 26 million cosmetic touch-ups were performed last year
A consumer watchdog is calling on federal authorities to require Botox makers to include warnings about the risk of a deadly muscle-paralyzing disease.
The advocacy group Public Citizen filed a petition Tuesday urging the FDA to force manufacturers to provide clearer warnings about how the drugs can cause systemic iatrogenic botulism, even at recommended doses.
The fatal condition occurs when the toxins used in Botox treatments spread beyond the intended treatment sites and cause muscles to sag.
The request comes after the group analyzed 5,400 reports of deaths, life-threatening events and other side effects linked to Botox and other cosmetic wrinkle treatments that use these toxins.
Botox, which lasts three to four months, works by relaxing the muscles in the face to smooth out lines and wrinkles
Public Citizen said it wants a stronger warning for the following brands of Botox: AbbVie, Daxxify by Revance Therapeutics, Jeuveau by Evolus, Myobloc by Supernus Pharmaceuticals, Dysport by Galderma and Xeomin by Merz Therapeutics
The reports were submitted between January 1989 and March 2021 and included in the FDA's Adverse Event Database.
The group said the petition “requests that the black box warning for both cosmetic and therapeutic Botox and related medications should make clear that they are associated with systemic iatrogenic botulism and related symptoms, even when used at recommended dosages, in the initial or subsequent phase. repeated) treatment.'
They also asked the FDA to remove a promotional paragraph that stated that there are “no definitive reports of serious adverse events from the spread of toxic effects over distance” associated with Botox when taken at the recommended dose for cosmetic use and for chronic health conditions such as excessive sweating and chronic migraines.
Azza AbuDaga, healthcare researcher at Public Citizen's Health Research Group, said: 'Our petition is based on clear post-marketing evidence that refutes industry propaganda claiming that Botox and related drugs are 'always safe' and that there there have been no 'definitive' cases of botulism. occurred at recommended doses.'
Public Citizen said it wants a stronger warning for the following brands of Botox: AbbVie, Daxxify by Revance Therapeutics, Jeuveau by Evolus, Myobloc by Supernus Pharmaceuticals, Dysport by Galderma and Xeomin by Merz Therapeutics.
Botulism is a rare infection in which the bacteria Clostridium botulinum, Clostridium butyricum or Clostridium baratali attack the body's nerves because they produce botulinum toxin.
According to the Centers for Disease Control and Prevention (CDC), this leads to difficulty breathing, muscle paralysis, double vision, drooping eyelids, slurred speech and difficulty moving the eyes.
If left untreated, it can lead to permanent paralysis and death.
One of the most common forms is food botulism, which is caused by food contaminated by botulinum toxin.
According to the most recent data available, the CDC recorded 215 cases of botulism in the US in 2019.
The most common sources of foodborne botulism are homemade foods that have been improperly canned, preserved or fermented.
However, iatrogenic botulism occurs when too much botulinum toxin is injected and extends beyond the intended treatment sites.
Botox works by blocking certain chemical signals from nerves that cause muscles to contract. This can reduce wrinkles and treat symptoms of conditions such as chronic migraines, incontinence and excessive sweating.
The FDA said it will review the petition and respond directly to Public Citizen.