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Botox must have stronger warnings, American regulator says

-Telegraph U.K.

06/11/2009 - Botox – the cosmetic wrinkle eliminating injection favoured by celebrities – must have stronger warnings on its packaging after serious side effects, the American drugs regulator has said.

The Food and Drug Administration has ordered extra safety warnings be placed on labels after cases where the toxin which temporarily freezes muscles, spread to other areas of the body causing muscle weakness, trouble talking, double vision, drooping eyelids, breathing and swallowing problems.

A statement from the FDA said the symptoms had mostly been reported in children with cerebral palsy being treated with botulinum toxin products for their muscle spasms but have also struck adults treated for medical problems.

Dr Russell Katz, director of the Division of Neurology Products in the FDA's Centre for Drug Evaluation and Research, said: "Updated labels for this class of products will help health care professionals and patients better understand the risks and benefits.

"Botulinum toxin products have benefits but can cause serious health problems and it is important that anyone who administers or uses these products understands these risks."

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