Botox for Cerebral Palsy Recommended Despite FDA Warnings

A panel of neurologists is recommending that Botox be used to treat some symptoms of spasticity associated with cerebral palsy, despite prior FDA warnings about the possible risk of serious and life-threatening reactions that have already killed several children who were given the injections off-label to treat the disability.

In an article published in the medical journal Neurology, a panel of experts from the American Academy of Neurology (AAN) published a review of several medications that could potentially be used to treat symptoms cerebral palsy. The article includes recommendations that Botulinum toxin type A, known by the brand name Botox, be used to treat spastic cerebral palsy, which is associated with difficulty moving, or stiff and jerky movements.

Botox, manufactured by Allergan Inc., contains extremely minute quantities of Botulinum Toxin A, which causes muscle paralysis. Although the medication is most commonly known for its cosmetic uses to remove wrinkles, it is also approved treat cervical dystonia, spasms of the eyelids and symptoms of severe underarm sweating. While some other countries, including Canada, have approved Botox for cerebral palsy, the FDA has not granted such approval in the United States.

In February 2008, the FDA issued a public health warning about potential Botox side effects when the medication is used to reduce spasticity among children with cerebral palsy. The agency indicated at that time that the medication had caused a number of hospitalizations and deaths due to paralysis, most frequently among children with cerebral palsy who are typically given a significantly larger dose of the medication.

A Botox “black box” warning was ordered in April 2009, indicating that side effects of Botox could cause potentially life-threatening problems similar to botulism if the medication spreads from the area of the injection to other parts of the body.

The recent recommendations by the American Academy of Neurology refer to FDA’s warning as “isolated cases of generalized weakness resulting in poor outcomes.”

“For children with CP, (Botox) is established as an effective treatment to reduce spasticity in the upper and lower extremities, but there is conflicting evidence regarding functional improvement,” the panel concluded. “The available evidence suggests that (Botox) is generally safe in children with CP. However, severe generalized weakness may occur.”

Allergan Inc. currently faces at least 15 Botox lawsuits that claim that the company hid the risks associated with the drug. Jury selection began this week in the first Botox trial, involving a case brought by the parents of 7-year-old Kristen Spears, a child with cerebral palsy that died in November 2007 after receiving seven shots of Botox. Allergan has argued that the girl’s death was unrelated to her Botox treatments and failed in an attempt to have the lawsuit dismissed late last year.