PRESS RELEASE For Immediate Release: October 20, 2006

Contact: Rita Shreffler, NAA (Nixa, MO) 417-818-9030 Wendy Fournier, NAA (Portsmouth, RI) 401-632-7523

FDA Approves Anti-Psychotic Drug Risperidone for Use in Children Diagnosed with Autism
National Autism Association urges parents and health care providers to carefully research side effects

Nixa, MO - The Food and Drug Administration (FDA) approved the anti-psychotic drug Risperidone (trade name Risperdal) earlier this month for use among children diagnosed with autism, much to the concern of parents familiar with the drug’s side effect profile. Manufactured by Johnson & Johnson subsidiary Janssen, Risperdal sales figures were over $3 billion in 2005. The FDA has approved the drug for pediatric use despite the fact that the agency issued a warning letter to Janssen in 2004 saying that the company had omitted information in product literature regarding hypoglycemia and diabetes, and had made misleading claims that Risperdal is safer than other drugs in the same category.

Documented potential side effects of 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,” said 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.”

The behavioral symptoms associated with autism are often due to undiagnosed medical issues including heavy metal toxicity, abdominal pain, constipation, parasites and food allergies. Many of these issues can be relieved by more benign interventions to address the cause of the behaviors, rather than masking them with drugs.

“Medical treatments are working backwards,” said 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.”

Another Johnson & Johnson’s company, Ortho Clinical Diagnostics (OCD), manufactured RhoGAM, a RhoD Immune Globulin given to Rh-negative women during pregnancy and following delivery. RhoGAM exposed fragile, developing fetuses to a bolus dose of mercury-based thimerosal. The neurotoxin was used as a preservative until OCD changed production methods in 2001. Many parents and scientists believe thimerosal to be the leading factor in the increase of neurological injuries such as autism among children.

“It’s ironic that the same company that gave us RhoGAM now stands to further increase profits from a drug that suppresses symptoms of neurological damage consistent with mercury toxicity,” commented Shreffler. “Risperdal does nothing to address the neurological injuries of children diagnosed with autism, and the potential side effects are frightening.”

For more information on autism, visit www.nationalautism.org

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