LUVOX (fluvoxamine maleate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved April 1997

Specific Treatments:

obsessive compulsive disorder

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General Information

LUVOX (fluvoxamine maleate) has been approved for the treatment of obsessive compulsive disorder (OCD) in children and adolescents.

Clinical Results

A 10-week, randomized, double-blind, placebo-controlled, multi-center study of LUVOX Tablets involving 120 children ranging in age from 8 to 17 years showed that fluvoxamine is more effective than placebo for the treatment of OCD. LUVOX Tablets was also well-tolerated; only three children taking fluvoxamine dropped out of the study due to adverse effects, none of which were considered serious.

Side Effects

Most commonly observed side effects included agitation, hyperkinesia, depression, dysmenorrhea, flatulence and rash.

Additional Information

OCD can strike in children as young as three or four, but is often undetected at this early age. Although children and adults experience many of the same obsessions (fear of contamination, need for symmetry, excessive doubt) and compulsions (excessive cleaning/washing, arranging/organizing, checking/questioning), children and adolescents with OCD are more likely to involve family members in their rituals. For example, they may insist their laundry be washed several times, demand that parents check their homework repeatedly, or become upset if siblings "contaminate" their bedroom.

Research suggests that OCD is caused by an imbalance of the brain chemical called serotonin. This imbalance can be genetic, even thought the disorder itself may not be hereditary. People with OCD experience unwanted, recurrent and disturbing thoughts they are powerless to suppress. This causes overwhelming anxiety, prompting them to perform repetitive, ritualized, compulsive behavior to alleviate the anxiety.

According to the National Institutes of Health, childhood OCD is more prevalent than other childhood ailments such as juvenile diabetes (100,000 cases in children 19 and under), yet remains largely undiagnosed and untreated. In young children, the disorder is often unrecognized because parents may attribute obsessive-compulsive behavior to a developmental stage and youngsters may not realize their thoughts and actions are unusual. Older children may hide their behavior, fearing that they are going crazy. Keeping this secret is exhausting and typically undermines a child’s ability to function normally in school and at home. Relationships with family and friends deteriorate, and parents agonize over their child’s peculiar behavior and hope "the phase" will pass quickly.

Children with OCD experience physical exhaustion and mental anguish from compulsive rituals such as repeated checking of school assignments, and obsessive fears such as harm coming to a family member as a result of household items being in disarray. Juvenile OCD can be particularly devastating because it coincides with a crucial period of social and emotional development. Schoolwork, home life and friendships are often affected.