A <"http://www.yourlawyer.com/topics/overview/botox">Botox overdose is being blamed for the death of a 7-year-old girl in California. The girl died in November 2007 of respiratory failure and pneumonia, after receiving Botox injections to treat cerebral palsy. Her mother has since filed a lawsuit against Allergan, the maker of Botox.
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.
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.
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, According to the Los Angeles Times, Kristen’s doctor has testified in a deposition that he learned to use Botox on children with cerebral palsy at Allergan-sponsored seminars in 2000 and 2001. He also said that an Allergan sales rep visited his practice 50 times where they discussed treating juvenile cerebral palsy patients.
Other documents detailed by the Times also indicate that Allergan was receiving reports about problems caused by Botox while Kristen was receiving her treatments. For example, in 200 Allergan sent a confidential report to the FDA, saying that an analysis identified 38 patients who had suffered seizures after Botox injections. Twenty were children, and most had cerebral palsy.
In 2007, a consulting firm provided Allergan with a confidential report that identified 207 patients with medical problems, including several deaths, associated with the spread of toxin. Proportionally, more problems were reported among children who received Botox to treat problems like muscle spasms, the Times said.
While Allergan was receiving these reports, Kristen was administered seven Botox treatments in a 15 month period, starting in June 2006. According to the Los Angeles Times, 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 at the age of 7.