According to a panel of experts advising the U.S. Food and Drug Administration (FDA), the drug Provigil, although effective in treating attention deficit hyperactivity disorder (ADHD) in children and teenagers, is not safe enough to win approval.
The experts say they are most concerned about the risk of skin rashes that can lead to hospitalization and have called on the drugmaker Cephalon to conduct more clinical trials.
Panel chairman Wayne Goodman, a psychiatrist at the University of Florida, believes more patients need to be studied before approval is granted.
The advisory committee voted 12-1 against recommending Provigil as safe for children with ADHD.
Provigil already has approval to treat sleep disorders, but Cephalon is seeking to market it under the name Sparlon for children and teenagers with ADHD.
The ADHD version of the drug, known generically as modafinil, would be a smaller tablet and offer a wider range of doses.
Conditional approval was granted by the FDA in October 2005 for use in ADHD, but lingering concerns about rashes as well as mania, aggression and other possible psychiatric effects prompted the added advice from an expert panel.
Thomas Laughren the FDA's Director of Psychiatry Products has said more work needs to be done to demonstrate a reason for it to be marketed.
Even if the wider use is approved it is almost certain Sparlon will come with the strongest warning possible, which will be at least a black box warning according to Dr. Robert Temple, head of the FDA's Office of Medical Policy.