The Food and Drug Administration’s approval of Risperdal as a treatment for autistic children has been challenged by the National Autism Association (NAA) due to concerns about the drug’s side effects. According to the NAA, side effects of Risperdal, or risperidone, include lactation both in girls and boys, weight gain, and development of the often irreversible movement disorder tardive dyskinesia.

“Any medication that can induce lactation in boys is clearly a dangerous drug, and in my opinion should only be used when all avenues of biomedical treatments have been exhausted,” says National Autism Association executive director Rita Shreffler. “Parents are faced with extremely tough decisions when it comes to medicating their children, and extra caution should be used with Risperdal in particular given what we know about it.”

Risperdal, manufactured by Janssen (a Johnson & Johnson subsidiary), generated approximately $3 billion in sales in 2005. On October 6, the FDA announced that it had “approved Risperdal (risperidone) orally disintegrating tablets, an adult antipsychotic drug, for the symptomatic treatment of irritability in autistic children and adolescents. The approval is the first for the use of a drug to treat behaviors associated with autism in children. These behaviors are included under the general heading of irritability, and include aggression, deliberate self-injury, and temper tantrums.” The FDA originally approved the drug in 1993 for the treatment of schizophrenia and bipolar disorder in adults.

At the time of the announcement, Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said, “This approval should benefit many autistic children as well as their parents and other care givers. Our agency strongly encourages the development of appropriate pediatric labeling for adult drugs, and Risperdal is a welcome addition to the growing number of such products that have been shown to have an appropriate risk-benefit profile when tested in children.”

However, the FDA’s decision has been derided by a growing number of critics in the medical and psychiatric fields. “Medical treatments are working backwards,” says NAA president Wendy Fournier. “We’re prescribed pills for a headache without addressing the cause of the headache. We must start treating the cause of medical illnesses, not just covering up symptoms, especially when it comes to the complex biomedical issues of children with autism.”

This entry was posted on Monday, October 23rd, 2006 at 4:16 pm and is filed under Health Concerns, Legal News.