FDA reviewing safety of Botox and rival product

By Lisa Richwine

WASHINGTON (Reuters) - U.S. regulators are reviewing the safety of Botox, best known for its cosmetic use, and a competitor amid reports that at least one child died following treatment for serious medical conditions, health officials said on Friday.

Shares of Botox maker Allergan Inc ended the day down nearly 6 percent to $63.30 on the New York Stock Exchange.

Serious reactions and hospitalizations of adults also were reported, the U.S. Food and Drug Administration said. Symptoms were suggestive of botulism, which occurs when the botulinum toxin in the products spreads in the body and paralyzes muscles, the FDA said.

No deaths were reported involving cosmetic use, the FDA said. One hospitalization was reported in a person who got Botox to ease frown lines between the eyebrows but it was unclear if Botox was the cause, the FDA said.

Most of the serious cases were in children treated for limb spasms from cerebral palsy, the agency said. That use is not approved in the United States, but is cleared in other countries.

The FDA declined to provide the number of reports it has received. Dr. Russell Katz, director of the FDA division that oversees the products, described the numbers as a "relative handful" that included at least one death.

Allergan said in a statement that use of Botox to treat juvenile cerebral palsy and other lower limb spasticities involves higher dosages than some of the other approved uses of the product, including treatment of wrinkles between the brows.

The company also emphasized FDA comments that this population of patients tends to be "very sick" and generally at higher risk of serious adverse events and death than a healthy population.