Saturday, August 19, 2006

Fatal Side Effect Stops New Psych Drug

Information From New Scientist Here is the info without the feel good marketing

Concerns about a potentially fatal side effect have crushed plans to market modafinil as a treatment for attention deficit hyperactivity disorder (ADHD). A proposal to market it for treating ADHD hit a snag in March when a child taking part in a clinical trial developed a life-threatening skin condition (New Scientist, 1 April, p 8).

Manufacturer Cephalon of Frazer, Pennsylvania, tried to convince the Food and Drug Administration that the child's rash was not a reaction to the drug. It has now abandoned its ADHD plans after the FDA refused to approve modafinil without further extensive safety studies.

"It's really unfortunate," says James Swanson, a psychologist at the University of California, Irvine, who was involved in Cephalon's ADHD trials. He still believes modafinil is safer than other stimulants, which may cause hallucinations in a minority of children.

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