FDA reviewing safety of Botox and rival product

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FDA reviewing safety of Botox and rival product

Fri Feb 8, 2008 8:50pm EST

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.

Botox is famous for smoothing facial wrinkles but also has other approved medical uses such as treating cervical dystonia, or rigid neck muscles. A competitor, Solstice Neuroscience Inc's Myobloc, is cleared only for the neck condition. Neither is approved for children under 12.

But doctors are free to use the drugs for any use they consider appropriate.

Reactions were reported in people getting the products for approved as well as unapproved uses and a variety of doses, the FDA said. Reactions may be related to overdosing, it added.

The agency said it was in the early stages of a review of Botox, Botox Cosmetic and Myobloc.

Until the FDA completes its review, officials advised patients to seek medical attention if they develop signs of botulism such as weakness or trouble swallowing or breathing.

Even for cosmetic use, "people should be aware this is a possibility, however rare, and if they do develop these symptoms they should take note of them," Katz told reporters.

Caroline Van Hove, a spokesperson for Allergan, said the company would cooperate with the FDA in its investigation.

Van Hove noted that treating childhood cerebral palsy is an approved use in about 60 other countries, and said the company is aware that doctors use it for that purpose in the United States, although it does not market the drug for that use.

Solstice Neurosciences said it supported the FDA review, but noted the agency's announcement did not mean it had concluded the products caused the reactions.

Last month, consumer group Public Citizen petitioned the FDA to require a strong "black box" warning to highlight the possibility of the botulinum toxin spreading and causing serious complications. The group said it had reviewed 180 reports of muscle weakness, difficulty swallowing and other problems, including 16 fatal cases.

Allergan projected in November that worldwide sales for Botox would top $1.1 billion in 2007.

Jefferies & Co analyst Peter Bye said a likely outcome would be for the FDA to require a black box and discouraging prescribing it for unapproved uses.

But, Bye said, a similar warning was issued in Europe, and "We didn't see any hiccups in European growth when the warnings were put on."

Bye, who has a "buy" rating on Allergan shares, said the stock decline was likely unwarranted, noting Botox's strong safety track record.

"There obviously is some risk" of more severe FDA action, Bye said. "But given the history of the product ... I wouldn't think it's high."

Greater FDA scrutiny could work in Allergan's favor, Bye said. It could mean there will be a longer U.S. review period for Reloxin, a potential Botox rival from Medicis Pharmaceutical Corp.

(Reporting by Lisa Richwine, Kim Dixon, Lewis Krauskopf and Deena Beasley; Editing by Gunna Dickson and Carol Bishopric)


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