BOTOX has been getting a lot of bad press recently. First, the potential use of black market Botox in terroristic activity. Now it is the focus of a lawsuit in Orange County, California by a mother who alleges that the Botox treatments used to decrease muscle spasms weakened her daughters respiratory muscles, therefore causing her death.
Kristen Spears’ mother has sued Allergan alleging that her daughter died from a fatal reaction to the Botox treatments Kristen received for treatment for cerebral palsy. The trial began two weeks ago. I have looked for updates, but found none.
BOTOX is most commonly known for it’s cosmetic uses in wrinkle reduction, but is approved by the FDA for treatment of cervical dystonia, strabismus, blepharospasm, primary axillary hyperhidrosis, and glabellar wrinkles. It is also used "off label" for a variety of more prevalent conditions that include migraine headache, chronic low back pain, stroke, traumatic brain injury, cerebral palsy, achalasia, and various dystonias.
The treatments in cerebral palsy are used to decrease muscle spasms. A multidisciplinary panel systematically reviewed relevant literature from 1966 to July 2008 and published their recommendations in the Journal Neurology:
For localized/segmental spasticity, botulinum toxin type A is established as an effective treatment to reduce spasticity in the upper and lower extremities. There is conflicting evidence regarding functional improvement. Botulinum toxin type A was found to be generally safe in children with cerebral palsy; however, the Food and Drug Administration is presently investigating isolated cases of generalized weakness resulting in poor outcomes.
Recommendations: For localized/segmental spasticity that warrants treatment, botulinum toxin type A should be offered as an effective and generally safe treatment (Level A).
Botox, manufactured by Allergan Inc., contains extremely minute quantities of Botulinum Toxin A, which causes temporary muscle paralysis. A Botox “black box” warning was ordered by the FDA in May 2009 due to reports that the effects of the toxin may spread from the area of injection to other areas of the body causing serious adverse problems. This label requirement is required on Botox and Botox Cosmetic (botulinum toxin type A); Myobloc (botulinum toxin type B); and a new FDA-approved product, Dysport (abobotulinumtoxinA).
When the botulinum toxin spreads beyond the area injected the toxin can cause symptoms similar to those of botulism. These symptoms include 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
According to AboutLawSuits.com Allergan Inc. currently faces at least 15 Botox lawsuits that claim that the company hid the risks associated with the drug.
REFERENCES
LA Times
Practice Parameter: Pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review); NEUROLOGY 2010;74:336-343
