This is the FDA's first public notification that Botox, Botox Cosmetic and Myobloc are linked to serious adverse effects. Allergan Inc's Botox and Solstice Neurosciences Inc's Myobloc, which is used for treating cervical dystonia, which is a condition that causes rigid neck muscles, are the drugs under the scanner.

"The notification is in keeping with the FDA's commitment to inform the public about its ongoing safety reviews of drugs," the FDA revealed.

The agency added that there was no defect in the products themselves, which are manufactured from the botulinum toxin. FDA said the adverse events were in most cases related to overdosing and wrong use.

One of the main areas of concern is the use of Botox in "children treated for spasticity in their limbs associated with cerebral palsy." FDA said it had not approved "use of botulism toxins in children or adults" for treatment of spasticity.

According to the FDA

"Botox (botulinum toxin type A) is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).  Botox Cosmetic, also botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines.

Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children have not been established."

The FDA said it was reviewing data submitted by the drug manufacturers and would reveal full results once the review was completed.

According to the National Institutes of Health, Botox is a drug made from a toxin produced by the bacterium Clostridium botulinum; the same toxin that also causes fatal food poisoning called botulism.

"Botox injections work by weakening or paralyzing certain muscles or by blocking certain nerves. The effects last about three to four months," the NIH said, adding that pregnant or breast feeding women must not use the product.

The FDA's communication follows calls by advocacy group Public Citizen to put stronger warnings on Botox and Myobloc. Public Citizen said that it had reviewed 180 case reports submitted to the FDA by the manufacturers and found several cases of muscle weakness, difficulty swallowing or aspiration pneumonia.

Of the 16 deaths alleged to have been caused by the injections, just one death was traced to the cosmetic use of Botox. The rest of the deaths were attributed to use of the injections for painful muscle conditions, but the exact causes are unknown at the moment, Public Citizen said.

For more information on the FDA's communication, please visit http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm

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