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FDA investigating safety of Botox

The safety of the anti-wrinkle wonder injection Botox is being called into question, with U.S. drug safety regulators Friday putting the product under review after reports of death or serious reactions, the most severe in children taking the product for spasms related to cerebral palsy.

The FDA said there is no need for health professionals to discontinue prescribing Botox or a similar treatment known as Myobloc. Some doctors say the dosages used to treat such spasms are far higher than those used for cosmetic reasons, suggesting less reason to worry about the product as a treatment for wrinkles and facial lines.

The agency did not focus attention on the risk to cosmetic users but said the investigation is in its early stages. The most severe reactions were found in unapproved uses for “children treated for spasticity in their limbs associated with cerebral palsy.” The products have been linked in some cases to adverse reactions, including respiratory failure and death. The FDA said doctors and their patients should be on the lookout for signs of difficulty of swallowing, weakness and breathing problems.

Botox and Myobloc, known as botulinum toxins, block the impulses of nerves and therefore cause them to relax. The toxins can spread beyond the injection site to other parts of the body, which doctors and the FDA say can weaken muscles used for breathing and swallowing and potentially be harmful.

Eventually, the toxins become metabolized in the body and are broken down, but their potential spreading to other parts of the body can be worrisome, doctors say.

Botox is best known for its cosmetic purpose in reducing the appearance of wrinkles by freezing, or paralyzing, muscles in the face. But the drugs are also used for a variety of muscle spasm conditions in the neck, vocal cords and in legs such as the case with children with cerebral palsy. The FDA said the most severe adverse effects, including at least one death, involve children being treated for “spasticity in their limbs.”

The FDA has never formally approved that use for the drugs.


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