The BOTOX Label Gets Ready for its Close-up

If you happen to land on the BOTOX Web site, one of the first things you will notice is a young woman who looks like she needs BOTOX about as much as a 3-year-old does.

Look a little closer and you’ll see a "Treatment Visualizer" that allows you to upload a wrinkled snapshot of yourself. Then, you fiddle with the controls, hit a button and up pops the new BOTOX-improved you. Who knew that cosmetic enhancement was as easy as hitting "Enter"?

Would that it were so simple! All medicines have their risks, and BOTOX is no exception. Now, in response to a Public Citizen petition last year about the dangers of BOTOX, the Food and Drug Administration (FDA) will intensify warnings to consumers about the serious side effects that can accompany this treatment.

Botulinum toxins (BOTOX, MYOBLOC and DYSPORT) are proteins produced by a bacterium, Clostridium botulinum, which causes botulism. Botulinum toxin blocks the transmission of nerve impulses to muscles, causing those muscles to become partially paralyzed.

The two broad approved uses for botulinum toxins are therapeutic and cosmetic. FDA-approved therapeutic uses include cervical dystonia (contractions of the neck and/or shoulder muscles that cannot be controlled), strabismus (crossed eyes) and blepharospasm (spasmodic, uncontrollable blinking of the eyes).

In addition, BOTOX and DYSPORT have one approved cosmetic use: temporary improvement of glabellar lines (wrinkles between the eyebrows). It is estimated that 2.5 million people had cosmetic BOTOX injections in 2008, but most cosmetic use is unapproved by the FDA because other parts of the body are injected.

But even beauty has its price.

In January 2008, Public Citizen petitioned the FDA to strengthen its warnings for this class of medications. Citing increasingly strong warnings issued by the European Union, we asked the FDA to require a black-box warning (the strongest warning the agency can issue) on the drug’s label alerting physicians to the drug’s propensity to spread to parts of the body distant from the injection site. In particular, if the gastrointestinal tract is affected, the ability to swallow could be impaired, the patient might regurgitate, inhale some stomach contents and develop pneumonia. Independent of swallowing problems, the drug can additionally impair breathing. We also asked for a letter to doctors warning of these dangers, as well as a mandatory FDA-approved medication guide to be given to patients when the drug is injected.

Our petition pointed to 180 cases in which the use of botulinum toxin was associated with difficulty swallowing, aspiration or pneumonia. Eighty-seven of the patients were hospitalized and 16 died.

Now, one day after DYSPORT’s May 1, 2009, approval (coincidence?), comes the FDA’s announcement that it has approved our petition. Not only are all of our requests to be granted for both therapeutic and cosmetic forms of the drugs, but the FDA also will require manufacturers to collect data on the drugs’ use in the treatment of muscle tightness associated with cerebral palsy, an unapproved use. In addition, the warning will point to paralysis of the breathing muscles as a potential complication of the drugs’ use. Because therapeutic use involves higher doses of the drugs than cosmetic use and because many therapeutic injection sites are closer to the gastrointestinal and respiratory, the risk of complications is probably higher for therapeutic uses.

The Grand Old Dame of faded beauty, Norma Desmond in Billy Wilder’s "Sunset Boulevard," would have approved. Finally, it seems, the BOTOX label is ready for its close-up.