Food and Drug Administration Orders Tougher Warnings on the Health Risks of Botox

The makers of licensed botulinum toxin products like Botox and Myobloc will need to change their products’ labeling to include boxed warnings on serious health problems that can result if the toxin spreads beyond the injection site, under a mandate issued today by the U.S. Food and Drug Administration (FDA).

The FDA order came after reports of adverse health problems and at least one death linked to the use of Botox to treat cerebral palsy and spasticity, which are uses that haven’t been approved by the FDA.

Botox is typically injected into the skin or into muscle tissue and has been approved by the FDA for cosmetic and other uses, including removal of frown lines, treatment of crossed eyes and eyelid twitches, and the prevention of severe underarm sweating. And no definitive health problems have been linked to the toxin spreading via these approved uses, Reuters reports.

According to an FDA Update, a number of pediatric cases in which botulinum toxin was used to treat cerebral palsy resulted in the toxin spreading beyond the injection site, and causing.

“symptoms that included difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression.”

While it is usually great news to learn that a current drug may have real applications for a serious disease, it is still incumbent on the manufacturer to perform the necessary testing and due diligence to ensure that the product is indeed safe for any use in which it is indicated.  Understandably, this is not an insignificant burden as it often requires pharmaceutical companies to start from square one in the testing and validation phase.  The costs can often be prohibitive, especially if the market for the drug is not as widespread for the newer application as it was for the previous one. However, the law of unintended consequences has a way of affecting endeavors that are not performed with the necessary and proper amount of care and oversight.

Manufacturers often see regulatory agencies like the FDA, or personal-injury attorneys as impediments to the purity of marketplace, which would magically guide negative outcomes to positive ones if the regulators and legal watchdogs would just get out of the way.  As is obvious after hundreds, if not thousands, of years of civilization, human nature will tend to push even well-meaning people to irresponsible and unethical behavior when the promise of profit is at hand.  Regulations and courts and the rule of law exist to curb the baser instincts of our nature and push us toward what is morally and ethically right and proper.

The FDA today also sent a letter in response to Public Citizen Health Research Group –which had petitioned the FDA to require stronger warnings on Botox — and notified the group that its petition was granted “with respect to your request that we require the BLA holders of botulinum toxin products to provide additional warnings (including a boxed warning) in product labeling regarding the risk of distant spread of the toxin effects from the site of injection.”

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