The mother of a 7-year-old girl who died on November 24, 2007 has filed a lawsuit against the Allergan Inc., the Irvine-based manufacturer of Botox. Kristen Spears, who was born with severe cerebral palsy, began getting Botox injections to calm muscle spasms associated with cerebral palsy in June 2006 when she was six years old. Her health deteriorated dramatically in the 15 months since she began Botox treatments in her legs, groin and chest, her mother says in a lawsuit filed against Allergan in Orange County. In the months since she began Botox treatments until she died, Kristen was hospitalized on 10 different occasions for breathing and swallowing difficulties.

Botox is approved by the FDA to treat frown lines and crossed eyes. However, doctors may prescribe the drug "off-label" for other purposes, including cerebral palsy. Health agencies in other countries have approved Botox specifically for treating cerebral palsy. Botox contains botulinum toxin, which relaxes muscles. Children being treating for symptoms of cerebral palsy receive a much higher dosage than adults given Botox for frown lines. If the toxin spreads, patients may have trouble swallowing and breathing.
Serious side effects of Botox are rarely reported. Allergan said in a confidential report to federal regulators that risk of death due to Botox in children with cerebral palsy was low. Fatalities were often the result of other underlying health conditions, Allergan said. However, in 2005, Allergan disclosed to the FDA that it had received reports of 20 children and 18 adults suffering seizures after being injected with Botox.
An article earlier this week in the LA Times said that Allergan has not commented on the trial. However, in a court document, Allergan said that Kristen passed away of an infection and that her mother, Dee Spears, cannot prove the allegations that Botox killed her.
Continue reading "Mother Sues Botox Manufacturer over Safety of Drug in Cerebral Palsy Treatments After Daughter's Death " »