Feb 9, 2008, 1:30 GMT
Washington - Botox, the toxin used in small doses to smooth facial wrinkles, has been linked to deaths in children who were treated for muscle spasms, US authorities said Friday.
Adults have also suffered serious side effects, including difficulty swallowing and numbness and weakness in the legs and feet, but no reported deaths, the US Food and Drug Administration (FDA) said.
The most serious cases led to hospitalization and death, mostly in children under 16 who were treated for muscle spasms linked to cerebral palsy, the FDA warning said. The effect may appear only several weeks after a botox injection, the agency said.
The FDA did not specify the number of fatal cases.
Botox is not approved as safe for use in children under age 12, the FDA said. But the agency said it was aware of reports that botox is used to treat spastic limbs in children.
Approved botox products already show warnings that typical doses can cause serious side effects, including difficulty breathing, in patients with disorders of nerves that control muscles, the FDA said.
Now, 'similar, potentially life-threatening' poisoning can result 'with other underlying conditions such as those with cerebral palsy- associated limb spasticity,' the FDA said.
Botox, or botulinum toxin, is a powerful poison produced by bacteria commonly found in spoiled meat and has been found to relax muscle activity. Commercially produced botox is used in tiny doses for cosmetic purposes.
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