Autism Group Voices Concern Over J&J Drug
23rd October 2006
By Victoria Harrison
The National Autism Association has said it has concerns over the FDA's approval of the anti-psychotic drug Risperdal earlier this month for use among children diagnosed with autism.
The group has specifically raised issue with the drug's side effects. The National Autism Association issued a warning letter in 2004 to Janssen, a subsidiary of Johnson & Johnson and the manufacturer of the drug. The warning said 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. The organization says there are documented potential side effects of the drug including lactation both in girls and boys, weight gain, and development of the often irreversible movement disorder tardive dyskinesia.
"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." said National Autism Association executive director Rita Shreffler
Johnson & Johnson's expanded approval of Risperdal has been approved to treat only irritability symptoms of autism in children. Side effects of Risperdal are included in the prescribing information provided with the drug. Johnson & Johnson has said that the safety and effectiveness of Risperdal in pediatric patients with autistic disorder less than five years of age have not been established.
Risperdal sales figures were over $3 billion in 2005.
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