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Wednesday, June 03, 2009
Botulinum toxin (“Botox”) Alert
Discovery that botulinum toxin when injected at selected sites in the face could temporarily eliminate wrinkles and other signs of aging has led to the commercial success of cosmetic “Botox” type products. But the toxin, produced by the bacterium Clostridium botulinum is a powerful neurotoxin used medically to treat muscle spasticity in children and adults and also as an alternative to surgery in treating a relatively rare condition called masseter muscle hypertrophy. In that condition one or both masseter muscles, which are used in chewing, swells in the area near the angle of the lower jaw, the mandible. The swelling may be disfiguring and also cause pain. Injection of the neurotoxin into the muscle inhibits the action of neurotransmitters causing selective paralysis and subsequent atrophy of the muscle.
The Cochrane Collaboration, an international and highly regarded agency conducting scientific reviews of clinical interventions of products used in the diagnosis, prevention or treatment of diseases, has recently completed a study of the use of botulinum toxin type A in masseter muscle hypertrophy. The reviewers concluded that there simply were not enough high quality studies to properly evaluate the toxin’s effectiveness nor its potential harms, and called for future research sufficient to provide evidence for people to make informed decisions about its use.
In parallel with the cautions raised by the Cochrane Collaboration, the Food and Drug Administration has raised the bar in advertising botulinum products. The agency, after an ongoing safety review begun in February 2008 is now requiring that manufacturers of licensed botulinum toxin products strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events should the toxin leak beyond the site where it is injected. FDA will also require manufacturers to develop and implement a Risk Evaluation and Mitigation Strategy. This “REMS” would include:
§ a communication plan to provide consumers with more information about the risks of toxin spreading beyond the injection site;
§ an explanation why various toxin products cannot be interchanged; and
§ a medication guide explaining the risks to patients, their families, and caregivers.
FDA is also requiring manufacturers to submit safety data after multiple administrations of toxin products in a specific number of children and adults with spasticity. For further information check the FDA Medwatch safety summary, including the link to the Communication about Botox, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164255.htm
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