A lawsuit against Botox Cosmetic was just filed and states that Botox killed four and injured 11. Plaintiff’s attorneys are urging for an end to the promotion of Botox’s off-label use and are requesting physicians be better trained in its use. The four deaths included two children and two adults according to the attorneys who added, “The two were children with cerebral palsy and they got very high doses to treat spasticity.” The two adults were a 69-year-old woman who died in March after receiving Botox to treat her shoulder and neck pain and a 60-year-old man who died in April after receiving Botox for excessive salivation.
Botox Cosmetic is approved for treating moderate to severe facial frown lines. Botox is medically approved for treating blepharospasm (involuntary blinking of the eye), cervical dystonia (involuntary contractions of the neck muscles), hyperhidrosis (excess sweating), and strabismus (crossed eyes); Myobloc is only approved for the neck condition. Both injections are made with forms of the botulinum toxin, which blocks nerve impulses to muscles, relaxing them. In off-label use, a physician uses a drug to treat a condition for which it is not specifically approved but for which evidence suggests it will help.
Meanwhile, the lawsuit claims that Botox maker Allergan promotes “off label” use for treating patients with cerebral palsy and other conditions not approved by the Food and Drug Administration (FDA) and that Allergan fails to appropriately warn Botox users of the possibility of fatal and life-threatening injuries from Botox injections. Another physician, Alan Gold, MD, a plastic surgeon in Great Neck, N.Y., and president of the American Society for Aesthetic Plastic Surgery, says off-label use carries additional risk that consumers need to be aware of. Only three of the 11 plaintiffs received Botox for cosmetic purposes; the remainder were treated with Botox for other conditions. Plaintiffs complaints included droopy eyelids, numbness, headaches, and swallowing and breathing problems.
By January, Botox and Myobloc were linked to 16 deaths and more hospitalizations due to botulinum toxin spreading inside the bodies of those patients. In response, Public Citizen, a U.S. consumer group, called for stronger warnings on the drugs and asked U.S. authorities to require the strongest possible warning—the black box—to be included on Allergan Inc.’s Botox and Solstice Neurosciences Inc.’s Myobloc. In February, the FDA announced its ongoing evaluation of reports of adverse reactions such as respiratory problems and death following the use of Botox and Myobloc for approved and unapproved uses.
Public Citizen said it reviewed 180 FDA reports involving patients injected with Botox or Myoblo, which detailed muscle weakness, difficulty swallowing, or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs. Sixteen cases were fatal and four of these involved children under 18; there were also 87 patient hospitalizations. Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said such problems could occur if botulinum toxin spreads from the injection site to places such as the esophagus, causing partial paralysis. Early symptoms of botulinum toxin include dry mouth, difficulty breathing or swallowing, slurred speech, drooping eyelids, and muscle weakness.
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