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Key Points
On January 24th, we all woke up to find the news saturated with stories around special interest group Public Citizen and its petition to the FDA for a black box warning label for botulinum toxins, e.g., Botox. This was relevant news to many of us, as Botox is an integral part of our practices and a popular treatment with our patients. It's no secret that Public Citizen loves to grab media attention; now, by pointing its finger at Botox, the media tsunami crested and broke in every major newspaper and on most broadcast outlets.
SILENCE OF THE PHONES While Public Citizen focused most of its energy and vitriol towards Botox for therapeutic purposes, many of us expected calls from concerned patients asking whether they should continue their Botox Cosmetic treatments. What we found was interesting — there were barely any inquiries and indeed, no reduction in patients. What was the reason for this? How come panic-stricken patients were not lining up outside our offices, expressing their fear of Botox?
Public Citizen's claims were irresponsible — the truth is that more than a million people have been treated with Botox for cosmetic use; in its entire history, there has never been a single reported death where a causal link to Botox Cosmetic has been established. The patients I treat with Botox for cosmetic purposes have nary a side effect, and overall, in its more than 18-year history since the product was first approved worldwide, reports of serious adverse events following Botox have been rare. Physicians know this and feel comfortable using Botox, and as a result, patients feel comfortable with the treatment and have built a trust in the Botox brand over many years. In fact, among my colleagues, there was an acknowledgement that the Public Citizen outcry may have an unintended positive effect — the attention around the issue may help drive prospective Botox patients to medical offices for treatment rather than nonmedical spas where Botox is so often injected.
SECOND WAVE I figured the Public Citizen issue would fizzle as quickly as it flared, but soon after, the FDA issued an early communication reviewing certain serious adverse events following the use of botulinum toxins. Once again, the media bit on the Botox story. The Botox brouhaha once again reared its head. It's important to know that the FDA's inquiry relates primarily to high-dose medical uses of Botox, particularly for the management of juvenile cerebral palsy (for which it is not approved in the U.S.), rather than its use for cosmetic purposes. What needs to be made abundantly clear to patients is that while Botox and Botox Cosmetic are of the same formulation (and are the same product), the dosing couldn't be more different. For instance, the dosing received by a healthy adult patient who receives Botox for aesthetic use generally ranges between 20 U and 50 U. In fact, I do not go above 100 U for cosmetic purposes. The most commonly reported use of botulinum toxin among the cases under review by the FDA are treatment of limb muscle spasticity associated with cerebral palsy where Botox doses ranged from 100 U to 700 U. Sadly, the treatment of juvenile cerebral palsy involves very compromised, terribly sick children and in some of these adverse event reports, the physician had used doses that were much higher than recommended for juvenile cerebral palsy in the labels for countries that have approved this use. By way of comparison, some of these adverse event reports indicated doses of greater than 30 times that of a typical aesthetic use on a per kilogram of body weight basis. From a patient's perspective, it's hard to glean all of this information from what was fed to us in the news. I doubt that patients are aware that the labels on Botox specifically warn that patients with pre-existing neuromuscular disorders may be at increased risk of clinically significant systemic effects from typical doses of Botox.
SHOCK VALUE During a time when facts could have been made clear to the public, many journalists instead chose to focus on sensationalistic terms such as "Botulism!" and "Death!" What isn't made clear to the public, and what clinicians like us know, is that the report of an adverse event following treatment with a drug does not by itself mean that the drug caused the event. For instance, due to the reporting rules of the FDA, if a female patient was recently injected with Botox Cosmetic and she became pregnant shortly thereafter, "pregnancy" would be subsequently recorded as an event following treatment with Botox, even though there is no correlation to the injection of Botox and pregnancy.
TOMORROW'S TEMPEST This Botox brouhaha is far from over. You can count on more communication from Public Citizen and the FDA, and as the media tide ebbs and flows, it's important to sift through the reports and make the facts available to our patients. Botox is a safe treatment when in the right hands and will continue to be a popular treatment for our patients. As more and more celebrities speak to the benefits of Botox Cosmetic, much in the way that superstar Vanessa Williams did during a Barbara Walters special before the Oscars a few months ago, people will continue to be curious about what Botox can do for them. It's important for us, as clinicians, to know all the facts and be educated. We need to impart this wisdom to the patients we serve on a daily basis.
