A woman in California has sued Allergan, the maker of Botox, alleging that the drug caused the death of her 7-year-old daughter in 2007.
According to a lawsuit filed by the mother of Kristen Spears, her daughter began receiving Botox injections when she was six to calm spasms in her legs caused by severe cerebral palsy. Experts hired by Kristen’s mother say that the girl died because Botox weakened muscles that controlled her breathing and swallowing, leading to respiratory failure and pneumonia.
Kristen was administered seven Botox treatments in a 15 month period, starting in June 2006. According to her mother’s lawsuit, her health began to fail, and she was hospitalized 10 times for breathing and swallowing problems, as well as pneumonia. She died just six weeks after her last treatment.
The lawsuit alleges that Allergan knew problems had been reported at least two years before Kristen died. Her mother also claims that the drug maker encouraged Kristen’s doctor to treat cerebral palsy patients with Botox and helped with his training.
Last April, the U.S. Food & Drug Administration (FDA) mandated a black box label for Botox and similar products that warned of the risk of adverse events when the effects of a botulinum toxin injection spreads beyond the site where it was injected. The label revision followed an FDA safety review prompted by reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity.
Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. However, doctors are permitted to use approved drugs in anyway they see fit.