FDA Approves Botox for Cosmetic Use
The FDA yesterday approved Botox, a toxin commonly used off-label to temporarily remove facial wrinkles, for limited cosmetic use, the Washington Post reports. Botox has been approved for treating severe muscle disorders of the face since 1989, and doctors recently began using it to remove wrinkles and frown lines. Although Botox has been used to remove all types of facial wrinkles, the FDA formally approved the treatment only for the removal of glabellar lines between the eyebrows. Botox, a purified form of the toxin that causes botulism, is injected into the affected muscles, blocking the release of a chemical that "would otherwise signal the muscle to contract." Irvine, Calif.-based Allergan, which manufactures Botox, says the treatment begins to work within two days and can last for as many as four months. The FDA approved the treatment after clinical trials of 405 patients found the drug to be effective. Less than 3% of clinical trial participants experienced some side effects, including face pain, redness at the injection site and muscle weakness. Allergan said it will market the treatment as Botox Cosmetic (Kaufman, Washington Post, 4/15).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.