Friday, March 24, 2006
The narcolepsy drug modafinil should not be approved as a treatment for attention-deficit hyperactivity disorder in children until more is learned about a possible link to a serious skin disease, federal advisers said yesterday.
A Food and Drug Administration advisory committee voted 12 to 1 against recommending modafinil as safe for children with ADHD. Earlier, the psychopharmacologic drugs panel unanimously agreed that modafinil works as a treatment for ADHD.
The FDA is not required to follow the recommendations of its advisory panels but usually does.
The committee recommended that Cephalon Inc. undertake a 3,000-patient trial to determine the risk modafinil may pose for Stevens-Johnson syndrome. Drug reactions cause nearly all cases of the sometimes fatal skin disease, which can produce widespread blistering and rashes, according to the Merck Manual.
The FDA's drug evaluation chief, Robert J. Temple, said one out of 900 children involved in earlier studies of the drug developed the disease. He and Cephalon spokeswoman Jenifer Antonacci said the agency and the company will discuss the committee's recommendation.
In December 1998, the FDA approved modafinil, under the brand name Provigil, for treating adults with sleepiness associated with narcolepsy. Other drugs approved by the FDA for ADHD include Ritalin, Strattera and Adderall.