A lawsuit was filed last month by a number of Botox users contending that the blockbuster product injured them or killed their relatives. The Plaintiffs allege that Allergan Inc., the manufacturer, failed to warn them of known dangers. The suit, filed in a California state court, links the toxin-based drug to three deaths, including one in March of a 69-year-old Texas nurse who received injections for neck and shoulder pain. The second death was that of a 7-year-old girl with cerebral palsy, also from Texas, who died in 2004, allegedly after receiving injections to control limb spasticity. The third death occurred last month in Arizona. In that case, a 71-year-old woman allegedly got Botox injections for wrinkles around her mouth at a mall clinic a year ago. It was alleged in the suit that after the injections, she had trouble swallowing and breathing, was unable to speak and lost weight until she died. All three deaths involved uses of Botox that were not approved by federal regulators.
The suit also contends that Botox injections both for approved uses, such as smoothing frown lines, and unapproved uses, such as treating migraines, left 12 other persons with a range of disabilities, including blurred vision, numbness, allergic reactions, flu-like symptoms, muscle weakness and difficulty breathing. Botox was first approved nearly 20 years ago. As expected, Allergan contends that Botox is totally safe. Several of the Plaintiffs in the suit were hospitalized and suffer from chronic, life-altering conditions. The most-common side effect mentioned in the suit is a loss of the ability to swallow, which causes a slow death from starvation or asphyxiation.
Botox is derived from botulinum toxin Type A, a form of one of the deadliest known poisons. In its raw form, the toxin kills by interrupting the communication between nerves and muscles, causing them to relax and leaving the victim paralyzed and susceptible to suffocation. In February, the FDA warned that it was reviewing reports of at least one death and other serious reactions among patients to botulinum-based drugs, including Botox and competitor Myobloc. FDA officials said at the time that they were unaware of any deaths among cosmetic users. The most serious of the reported problems occurred in children with cerebral palsy who were treated for arm and leg spasms with doses many times those recommended for cosmetic treatments.
The FDA warning followed Public Citizen’s announcement in January that it found reports linking 16 deaths to the use of Botox or Myobloc from 1997 to 2006. The consumer group also found that 180 patients had developed life-threatening conditions after being injected, leading to 87 hospitalizations. This suit will be watched closely. Like many of the drugs that have had serious safety problems, Botox is not a life-saving drug. We will keep our readers informed as to any significant developments relating to this litigation.
Source: Los Angeles Times
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