An FDA panel recommends that Provigil, which is supposed to be prescribed only to adults who suffer from narcolepsy and sleep disorders, should carry stronger warnings to discourage docs from prescribing the med to kids, even though labeling already says the drug isn't for pediatric use.
The Provigil label was recently updated to warn of the possibility of serious skin reactions and psychological problems such as hallucinations, anxiety and suicidal thoughts. Cephalon last month sent doctors a letter detailing the change and noted the drug is not approved for use in children.
However, the FDA panel worried that Provigil is sometimes used off label for use in treating attention deficit hyperactivity disorder in kids. In fact, last year an FDA panel rejected a bid by Cephalon to have a modified version of Provigil approved for treating children and adolescents with ADHD. Several panel members were concerned about off-label use and wanted to send a stronger signal that the drug shouldn't be used in children. So the 12-member panel unanimously voted that language stating Provigil isn't recommended for kids is needed, beyond language stating the med isn't approved for pediatric patients.
Source: The Associated Press