UPDATE 1-Cephalon drug needs stronger child warning-US panel
(Adds context, details from meeting)
GAITHERSBURG, Md. Nov 28 (Reuters) - U.S. health advisers called for stronger warning labels on Wednesday on Cephalon CEPH.O biggest drug, Provigil, noting the treatment for sleep disorder narcolepsy is not recommended in children.
The drug is not approved to treat children under 16 years old, but it continues to be prescribed to kids for conditions, including attention deficit disorder and narcolepsy, according to U.S. Food and Drug Administration staffers.
Provigil 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 Provigil's risks outweigh any benefits in children.
The FDA typically accepts the advice of its panels.
Provigil is Cephalon's flagship product with global sales of $415 million in the first half of 2007. The company has a slightly altered product called Nuvigil, which is not yet approved.
In 2006, an FDA panel rejected a bid by Cephalon for approval to treat children and adolescents with attention deficit hyperactivity disorder.
Earlier this year, the FDA added a new warning the risk of serious skin rash and psychiatric symptoms. Potential serious side effects include hallucinations and suicidal thoughts, the agency said.
(Reporting by Kim Dixon; editing by Tim Dobbyn and Andre Grenon)
((kim.dixon@reuters.com +1 202 841 1372; Reuters Messaging: kim.dixon.reuters.com@reuters.net)) Keywords: CEPHALON PROVIGIL/
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