The Consumer Protection Agency has urged U.S. authorities to require Botox manufacturers to include warnings about the risk of developing a deadly disease affecting muscles. On Tuesday, the Public Citizen group filed a petition urging the U.S. Food and Drug Administration (FDA) to compel manufacturers to provide clearer warnings about how the treatment may lead to potential poisoning, even at recommended doses. The lethal condition arises when the toxins used in Botox treatments spread beyond the intended treatment sites, causing muscle weakness.
This request follows the group's analysis of 5,400 reports of deaths and life-threatening events related to Botox and other cosmetic wrinkle treatments using these toxins. The reports were submitted between January 1989 and March 2021 and were recorded in the FDA's adverse events database. The group stated: "The petition requests that the black box warning for both cosmetic and therapeutic Botox, as well as related drugs, clarify that they are associated with therapeutic botulism (Botulism) and related symptoms, even when used at recommended doses." They also asked the FDA to remove a promotional statement claiming that "there are no definitive reports of serious adverse events due to toxin spread" associated with Botox when administered at the recommended dose for cosmetic use and for chronic health conditions like excessive sweating and chronic migraines.
For her part, Izzat Abu Daga, a health services researcher at Public Citizen, said: "Our petition is based on clear post-marketing evidence that refutes industrial claims that Botox and related drugs are 'always safe' and that there are no 'definitive' cases of poisoning with recommended doses." Botulism is recognized as a rare infection that occurs when bacteria from Clostridium botulinum, Clostridium butyricum, or Clostridium parabotulinum attack the body's nerves by producing botulinum toxin. According to the Centers for Disease Control and Prevention (CDC), this results in 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. In 2019, according to the latest available data, the CDC reported 215 cases of botulism in the United States.
