- The Washington Times - Saturday, February 9, 2008

ASSOCIATED PRESS

The drug Botox and a competitor have been linked to dangerous botulism symptoms in some users, including a few cases in which children have died, the government warned yesterday.

The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated with the drugs for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some countries have.

Botox is best known for minimizing wrinkles by paralyzing facial muscles — but botulinum toxin also is widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.

The Food and Drug Administration’s warning includes Botox, a wrinkle-specific version called Botox Cosmetic, and its competitor, Myobloc — drugs that all use botulinum toxin to block nerve impulses, causing them to relax.

In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect, the FDA said.

However, the FDA warned that it also is probing reports of illnesses in people of all ages who used the drugs for a variety of conditions, including at least one hospitalization of a woman given Botox for forehead wrinkles.

The FDA wouldn’t say exactly how many reports it is investigating.

“We’re not talking hundreds. It’s a relative handful,” said Dr. Russell Katz, FDA’s neurology chief.

But the agency warned that patients receiving a botulinum toxin injection for any reason, cosmetic or medical, should seek immediate care if they experience symptoms of botulism, including: difficulty swallowing or breathing, slurred speech, muscle weakness, or difficulty holding up their head.

“I think people should be aware there’s a potential for this to happen,” Dr. Katz said. “People should be on the lookout for it.”

Yesterday’s warning came two weeks after the consumer advocacy group Public Citizen petitioned the FDA to strengthen warnings to users of Botox and Myobloc, citing 180 reports of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths.

Nor is it the first warning. The drugs’ labels do warn about the potential for botulinum toxin to spread beyond the injection site and occasionally kill, but the warnings link that side effect to patients with neuromuscular diseases.

That’s what’s different about these latest cases, said FDA’s Dr. Katz: The botulism toxin seems to be harming people who don’t have that risk factor of a neuromuscular disease.

Still, the FDA cautioned that its investigation is in early stages. It has asked Botox maker Allergan Inc. and Myobloc maker Solstice Neurosciences Inc. to provide additional safety records.

Allergan spokeswoman Caroline Van Hove said children with cerebral palsy receive far larger doses injected into their leg muscles than the doses given to adults seeking wrinkle care.

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