Recent controversy has surfaced regarding the systemic side effects of botulinum-toxin based injections. Public Citizen, a leading consumer watchdog group, petitioned the FDA to increase its warnings about the risks of Botox® and Myobloc®. This petition came after the group’s safety analysis of FDA data revealed that from 1997 to 2006 there were 658 cases of patients experiencing adverse effects after being injected with the toxin. The group said 180 of these cases suffered potentially life threatening conditions, such as pneumonia and difficulty swallowing. According to the analysis, there were 16 deaths associated with the use of the toxin.
This issue stirred up some commotion among Botox® injectors (as well, I’m sure, as Botox® injectees) to find out the truth behind the analysis. Everyone was asking: is this risk real? It seemed unthinkable to have such grave complications using Botox® at the small cosmetic doses most commonly used.
The truth of the matter is that most of the adverse, potentially life-threatening events and deaths occurred after injection of large doses of the toxin into children diagnosed with cerebral palsy. The high dose injections were given into the arms and legs of these patients to prevent muscle spasms. The doses given were much higher (often ten fold) than the recommended and commonly used doses used in the cosmetic industry. As well, many of these cerebral palsy patients had pre-existing conditions associated with difficulty swallowing as part of their disease process. This made it even more difficult to isolate an adverse event and attribute it solely to botulinum toxin.
Botox® is approved for more than 20 uses in more than 60 countries. Treatment of muscle spasms in children with cerebral palsy is one of the oldest uses and allows them the walk and move around. Although not approved for this use in the US, this treatment has proven beneficial for these children because it has fewer side effects than Valium and other systemic drugs and it is safer than surgery. In the proper doses, it has a well-established safety profile.
The only death linked to a cosmetic injection of the FDA approved toxin, that I am aware of, occurred in a patient who died of pneumonia. It was determined that this patient received a cosmetic injection of Botox® several weeks earlier. Without knowing the details of the case, I find it hard to believe that the cosmetic Botox® that was injected into this patient had anything to do with the patient’s pneumonia leading to death.
My thoughts are that with all the recent hype, everyone is going to be on high alert. Whenever a death occurs, if the patient happened to have a cosmetic Botox® injection anytime in their past, there could be potential blame.
The Physicians Coalition for Injectable Safety released a statement on January 25, 2008 addressing this issue: “Consumers who have had Botox® injections for cosmetic indications or who are considering Botox® for cosmetic indications should not be alarmed by recent reports of adverse events, but must put this report into perspective,” said Coalition Leader Mark L. Jewell, MD.
It is estimated that since 2002, 17 million cosmetic Botox® injections have safely been administered.
Bottom line: Botox® can safely be used for the treatment of cosmetic wrinkles, as well as for many other indications. It is important that patients seek treatment from board-certified physicians who are knowledgeable about proper administration, dosage, and potential side effects associated with the injections so that they can be avoided. Also, only FDA approved botulinum toxin should be used.
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