WASHINGTON (Reuters) - Allergan Inc's wrinkle-filler Botox and a similar product must carry a strong warning about the risks of severe complications if the injected botulinum toxin spreads in the body, U.S. regulators said on Thursday.
The Food and Drug Administration said the move followed the investigation of deaths and hospitalizations of children, most of whom were given one of the products to treat cerebral palsy. Most harm in adults occurred after treatment of spasticity or cervical dystonia, the FDA said.
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