Newswise — Health care professionals and patients must be aware of the amount of botulinum neurotoxin products administered to prevent the serious adverse events that have prompted the U.S. Food and Drug Administration to change safety labels on products including Botox, urges Joseph McArdle, Ph.D., a professor at the UMDNJ-New Jersey Medical School.
"Because the toxin is so potent, it does not require much of an error for the effect to be less than optimal," added McArdle, who teaches pharmacology and physiology and anesthesiology at the school.
FDA-approved preparations of BoNT serotypes A and B are locally injected to achieve effects ranging from relief of muscle spasticity (e.g., associated with cerebral palsy, focal dystonia) to removal of wrinkles.
On Thursday, the FDA announced that safety label changes, including a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products. The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. The agency also took the action because of the potential for serious risks associated with the lack of interchangeability among the three licensed botulinum toxin products.
"Clearly, BoTox is a double-edged sword which must be approached carefully," McArdle said.
The University of Medicine and Dentistry of New Jersey (UMDNJ) is the nation's largest free-standing public health sciences university with nearly 5,700 students attending the state's three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and a school of public health on five campuses. Annually, there are more than two million patient visits at UMDNJ facilities and faculty practices at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden and Stratford. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, a statewide mental health and addiction services network.
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