GAITHERSBURG, Md., Nov 28 (Reuters) - U.S. health advisers on Wednesday advised slapping a stronger warning label on the Cephalon CEPH.O drug Provigil, noting the treatment for sleep and depressive disorders is not recommended in children.
Provigil, used to treat people who have difficulty staying awake and one of Cephalon’s biggest products, is not approved to treat children under 16 years old.
Despite that, it continues to be prescribed to kids for conditions including attention deficit disorder and narcolepsy, according to U.S. Food and Drug Administration staffers. The drug has serious known side effects including a serious rash called Stevens-Johnson Syndrome.
The FDA advisory panel recommended adding a more explicit label warning that the FDA has concluded that Provigil’s risks outweigh any benefits in children.
The FDA typically accepts the advice of its panels. (Reporting by Kim Dixon; editing by Tim Dobbyn)