IT HAD been touted as a safer alternative to the amphetamine-like stimulants prescribed to millions of hyperactive children and young adults. Now concerns about a potentially fatal side effect have crushed plans to market modafinil as a treatment for attention deficit hyperactivity disorder (ADHD).
Modafinil, which boosts wakefulness and focus, is approved for adults with excessive sleepiness. A proposal to market it for treating ADHD hit a snag in March when one of 933 children taking part in a clinical trial developed a life-threatening skin condition (New 杏吧原创, 1 April, p 8).
鈥淎 child in the clinical trial developed a life-threatening skin condition鈥�
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Manufacturer Cephalon of Frazer, Pennsylvania, tried to convince the Food and Drug Administration that the child鈥檚 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.
鈥淚t鈥檚 really unfortunate,鈥� says James Swanson, a psychologist at the University of California, Irvine, who was involved in Cephalon鈥檚 ADHD trials. He still believes modafinil is safer than other stimulants, which may cause hallucinations in a minority of children.
