Mother Blames Botox for Daughter’s Death, Manufacturer Faces First Lawsuit

A woman in Potter County, Texas, has sued Botox manufacturer Allergan Inc., claiming that Botox injections (botulinum toxin type A) led to her 7-year-old daughter Kristen’s death in November 2007, just 15 months after she began treatment with Botox for cerebral palsy.

Dee Spears claims that the company wrongfully promoted off-label uses of the drug and failed to warn consumers of the risks involved with high doses of the injections. Trial proceedings began on January 27, 2010. This will be the first case to reach trial alleging a fatal reaction to Botox.

Kristen Spears started receiving Botox injections in 2006 to treat severe arm and leg spasms that are associated with cerebral palsy. Her mother states that Kristen experienced an increased severity of seizures, difficulty swallowing, and contracted pneumonia before her death. Experts in the trial suspect that Botox can weaken the muscles that control breathing and swallowing when injected in large amounts for muscle spasms.

Botox is currently not approved in the U.S. for the treatment of spasticity (spasms) in children with cerebral palsy, but it is widely prescribed by doctors as an off-label treatment for the condition. The drug is injected in large doses, up to 15 times the cosmetic dose, directly into muscles to reduce rigidity and allow patients to move and walk more easily.

Allergan spokesperson Crystal Muilenburg stated that “the evidence presented in this case will show that Botox did not play a role in this,” with an early court motion claiming that the girl died of a bacterial infection unrelated to Botox.

Earlier this week, an issue of Neurology, the medical journal of the American Academy of Neurology, published results of a study that found botulinum toxin type A to be “effective and generally safe” as a treatment for spasticity and muscle tightness associated with cerebral palsy, but with some risks involved.

In 2008, the Food and Drug Administration (FDA) revised warning labels on Botox following reports of adverse reactions and some deaths associated with both FDA-approved and unapproved uses of the drug. The most serious cases of hospitalization and death occurred mostly in children with cerebral palsy. Serious side effects reported with Botox treatment include loss of strength, muscle weakness, loss of bladder control, difficulty breathing, trouble swallowing, double vision, pneumonia, and respiratory depression.

Additional information about drugs and drug side effects can be found on Drugwatch.com.