The Food and Drug Administration (FDA) has cleared fluvoxamine maleate for use in treating obsessive-compulsive disorder (OCD) in children and adolescents.

The drug is marketed jointly by Solvay Pharmaceuticals Inc. and Pharmacia and Upjohn Inc. under the brand name Luvox.

While the FDA routinely approves new indications for approved drugs when presented with compelling proof of safety and efficacy, there is a dearth of psychiatric medications specifically tested for use in children (see article above). Fluvoxamine is the first selective serotonin reuptake inhibitor approved for OCD in children.

More than 400,000 children age 17 years and under suffer from severe OCD, according to the National Institute of Mental Health (NIMH).

Mark Riddle, M.D., is director of the Division of Child and Adolescent Psychiatry at Johns Hopkins University, Baltimore, and principal investigator in the Research Unit on Pediatric Psychopharmacology, one of a series of such units recently funded by the NIMH.

When it comes to psychiatric drugs, children are "therapeutic orphans," Riddle told Psychiatric News. The clinical testing of fluvoxamine required to obtain FDA approval for use in children needs to be replicated for other psychiatric drugs now approved for adults but often prescribed off-label for children, said Riddle.

According to distributor Solvay Pharmaceuticals Inc., the trials that led to the new indication involved 120 children ages 8 to 17 years. Of those, only three dropped out of the study due to intolerable side effects.

(Psychiatric News, May 16, 1997)