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Botox Side Effects Lead to Heightened Warnings

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Botox, the well-known injectable drug used for cosmetic purposes and some muscle spasms, has come under fire for inadequate warnings about off-label uses. The drug, which utilizes a toxin known as botulinium toxin type-A, is approved by the US Food and Drug Administration (FDA) for removal of facial wrinkles, relief of excessive sweating, and treatment for cervical dystonia and other facial muscle spasms.

The drug works by paralyzing the targeted muscles or nerves. Results can be expected to last three to four months.

The toxin, which is essentially the same bacterium that causes botulism, can have dangerous side effects if not properly used. If the toxin spreads throughout the body, the patient can suffer from muscle weakness, difficultly breathing, blurry vision, loss of bladder control, and even death. Of particular concern is the use of Botox to control muscle spasticity in children, including those with cerebral palsy. The FDA has not approved the use of Botox for that purpose, and some injuries has been reported as a result of this off-label use.