The drug used for cosmetic purposes and some muscle spasms known as Botox has received criticism for inadequate warnings about off-label uses.

The FDA-approved drug uses a toxin known as botulinium toxin type-A to remove facial wrinkles, relief of excessive sweating, and treatment for cervical dystonia and other facial muscle spasms. The toxin paralyzes the targeted muscles or nerves for an average three to four months.

If improperly used, the toxin (which is essentially the same bacterium that causes botulism) can spread throughout the body, causing muscle weakness, difficulty breathing, blurry vision, bladder control, and even death.

Another concern is the use of Botox to control muscle spasticity in children, including those with cerebral palsy. The FDA has not approved the use of Botox for that purpose; several injuries have been reported as a result of this off-label use.

As President-Elect Barack Obama’s administration comes together, one very important spot is the choice of  commissioner of the US Food and Drug Administration.

The next commissioner will need to be prepared for the policy and operational issues currently occurring at the FDA. Over the past few years, the FDA has received much criticism about its ability to enact drug-product safety (such as in the case of defective drugs like Vioxx) or adequately regulate manufacturers and the inspection of their facilities (in the contaminated heparin case).

Several names under consideration are Joshua Sharfstein, the commissioner of health for the city of Baltimore; Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic; and Janet Woodcock, the current director of the Center for Drug Evaluation and Research at the FDA, among others.