Prior to its FDA-approval in 2002 for cosmetic use, botulinum toxin, type A, Botox, earned FDA-approval for use in humans nearly a quarter of a century ago. During that time, thousands of patients have been treated with it for cervical dystonias (rigidity of the neck muscles), torticollis (tightly twisted neck and shoulder spasm), vocal cord paralysis and strabismus (eye muscle abnormalities leading to cross-eye problems, etc.). In 2006, four million injections of Botox were given in United States alone for purely esthetic reasons, and millions more have been administered in numerous countries worldwide.

Recently, concern has been raised about the safety of Botox in light of the fact that 180 adverse reactions were reported in patients receiving Botox for various conditions, with 16 deaths occurring among this group, including four children. The issue was raised about the ability of Botox to spread outside of the intended treatment sites into areas that may affect respiration, leading to serious or fatal consequences.

It must be emphasized that reports of adverse reactions while a person is on any given therapy do not prove a causal effect. All that can be said with certainty is that there remains the possibility that the particular drug or treatment MAY be related to the problem.

Additionally, it should be stressed that the amounts and concentrations of Botox used for treating the medical conditions mentioned above tend to be considerably higher than those needed to deal with cosmetic problems. Typically microdroplets of relatively dilute material are needed to handle the wrinkles of expression, whereas large amounts of concentrated solutions are required to work on the thick muscles of the neck or back. And the more material injected, the greater the possibility that some may migrate to regions outside of the treatment sites.

It would also be of interest to examine the level of experience of the injectors in these reported cases. Injections of Botox for any indication, particularly in the neck region, should be left to the hands of experienced physician injectors to ensure that the appropriate dilutions and technique are employed to maximize patient safety. Having injections performed at a "Botox party" by an inexperienced physician or non-physician is not wise. Experience and training are of paramount importance for maximizing patient results and safety.

The fact is that the safety profile of Botox, especially when used for cosmetic purposes, is quite remarkable, if one takes into account the huge numbers of individuals undergoing treatment with it every year throughout the world. Any adverse reaction to any substance is of course regrettable and alertness to this possibility, no matter how rare, is certainly warranted. Panic is not, however. Countless people have lost their lives eating strawberries, yet we do not see FDA "black box" warnings on strawberry containers in the supermarket. I believe that these kinds of serious warnings, in the face of the relative infrequency of serious reactions to Botox, are not warranted and simply contribute to needless anxiety on the part of the public. Botox has proven itself over the decades to be a safe and highly effective treatment for a variety of conditions, and I predict that its use and indications will continue to grow well into the future.

For more information about the controversy, check out our article, "Botox-related Deaths Lead to Request for New Safety Warnings".

Dr. Novick discloses no financial interests in Botox or Allergen, its manufacturer.

In addition to Dr. Novick's roles as a bestselling author, clinical professor at The Mount Sinai School of Medicine in New York City and attending physician, he also maintains a private practice in Cosmetic Dermatology and Cosmetic Dermasurgery on Manhattan's Upper East Side. He has been featured on many popular television and radio shows and lent his expertise to scores of major publications.