Beauty treatment gets enhanced warning from FDA

5/1/2009

ROCKVILLE, Md. A popular beauty treatment will get an enhanced warning from the Food and Drug Administration following reports of serious side effects, the FDA announced Thursday.

The agency said that all botulinum toxin products, used to eliminate wrinkles and treat muscle spasticity from the skin, will get a boxed warning and be subject to a risk evaluation and mitigation strategy.

The FDA’s action follows reports that the toxin may spread from the area of injection to other parts of the body, resulting in symptoms similar to botulism. These include loss of strength and muscle weakness, difficulty speaking, loss of bladder control, vision problems and trouble breathing. Most of the symptoms have been reported in children with cerebral palsy receiving botulin toxin for muscle spasticity.

Products affected include Allergan’s Botox and Botox Cosmetic (botulinum toxin type A), Solstice Neurosciences’ Myobloc (botulinum toxin type B) and Ipsen Biopharm’s Dysport (abobotulinumtoxinA).

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