Botox Safety Update

Thursday, February 21, 2008

Botox Safety Update By Mark R. Pulera M.D.
As you may know, the FDA (Food and Drug Administration) has recently released information regarding the safety of Botox. In order to understand this information, one must realize that Botox is and always has been a potent medication only available by prescription under a doctor’s supervision. Botox is prescribed at a wide range of doses for a wide variety of clinical conditions. Botox-related compounds have been medically studied for at least 100 years, and Botox has been approved for medical uses by the FDA for 18 years. Botox has been FDA approved for the cosmetic treatment of moderate to severe frown lines between the brows in adults for 8 years. Since 2002, over 13 million people have received Botox Cosmetic treatment. Reports of serious side effects are rare, but just like with any prescription medication, serious side effects including death are possible with treatment. Allergan, the manufacturer of Botox, maintains that no deaths have ever occurred with Botox treatment for cosmetic reasons. It should be noted that “Botox” and Botox Cosmetic” are the same medications marketed under different names by Allergan. The consumer group, Public Citizen issued a statement on January 24, 2008 petitioning the FDA to issue stronger warnings to patients and doctors about the use of Botox because of serious side effects including death. Public Citizen disputes Allergan’s assertion that no deaths have been caused by Botox Cosmetic. We do not have the details of the disputed case at this time. However, the FDA released a communication regarding an ongoing safety review of Botox on February 8, 2008 which can be found at www.fda.gov/medwatch/safety/2008/safety08.htm#botox. The FDA reviewed Botox treatments in variety of pediatric and adult patients and found a number of pediatric cases with serious adverse events including death. These adverse events were found most commonly in children with cerebral palsy who received relatively high does of Botox for limb spasticity. The doses were approximately 10 to 50 times hight than a usual dose of Botox used for cosmetic purposes. Among the adult cases of Botox treatment systemic effects after injection such as weakness or numbness were noted, however no deaths were reported. The doses of Botox used in these cases were approximately 2 to 15 times higher than Botox used for cosmetic purposes. The release of this communication from the FDA regarding the safety of Botox does not mean that a causal relationship has been established between Botox and the adverse events described. Nor does it mean that the FDA is advising healthcare professionals to discontinue prescribing these products. The FDA will provide further updates which it has reached a conclusion regarding this issue. In the meantime, we should all be aware of the potential systemic side effects of Botox treatment including swallowing difficulty, speech difficulty, breathing difficulty or weakness. At Malana Medical Spa, we have always been aware of the potent nature of medications such as Botox including the possibility of serious adverse reactions including death. We always have used our understanding of the risks of Botox to minimize potential untoward side effects in all of our treatments. We agree with notion that all healthcare professionals who administer Botox must have a thorough understanding of Botox in order to maximize patient safety. Anyone who desires Botox treatment should realize that although treatment is extremely safe in the hands of a knowledgeable healthcare professional, there are risks to any medical treatment. We would not offer Botox or any treatment that we did not feel to be completely safe and effective, and we will continue to treat ourselves and patients with Botox as long as the evidence continues to support its safety. If you have any questions regarding Botox or other treatments, please call us at (310) 821-8800.