"The biggest advantage to Botox is its lack of side effects, especially compared to other medications," neurologist William Ondo, MD, of Baylor College of Medicine, said in June in an AHS news release.
"The FDA's first consideration is always safety, and I feel this product is very safe, or, obviously, I wouldn't have recommended its approval," says dermatologist Ella L. Toombs, MD, a former FDA official who served on the committee that approved Botox as a wrinkle treatment.
What isn't widely known, Toombs says, is that drugs such as Botox -- considered a lifestyle enhancer more than a lifesaver -- actually fall under more FDA scrutiny than proposed treatments for serious conditions.
"Every product the FDA evaluates looks at its benefit-to-risk ratio," she tells WebMD. "If you look at it from the standpoint of a cancer patient, one might be more willing to accept the adverse events of a certain drug more readily than when using a product that you don't necessarily need to improve health. Therefore, we really look at their safety."
Prior to its approval as a wrinkle treatment, the FDA initially approved Botox in 1989 to treat two eye disorders -- uncontrollable eyelid spasms and misaligned eyes -- and in 2000 to treat a condition that causes severe neck and shoulder contractions. It was a Canadian eye surgeon who first noted its wrinkle-reducing properties.
In other countries, such as the U.K., Botox has already been approved for other conditions, including excessive sweating and spasticity.
"Interestingly, except for cosmetic use, the U.S. is usually far behind other countries in the drug approval process," says Allergan spokeswoman Christine Cassiano, who acknowledges that Botox is currently being studied by private researchers and in corporate-funded clinical trials to test some of its other potential uses.