FDA Panel Opposes Use of Provigil to Treat ADHD in Children
Associated Press, March 24, 2006
The narcolepsy drug modafinil (Provigil) 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.
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