GAITHERSBURG, Md. Nov 28 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)