Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Psychiatry/Psychology | Family Medicine
View By:YearCompanyConditionsTherapeutic AreasDrug Names
LUVOX (fluvoxamine maleate)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Solvay Pharmaceuticals, Pharmacia & Upjohn
Approval Status: Approved April 1997
Treatment Area: obsessive compulsive disorder
LUVOX (fluvoxamine maleate) has been approved for the treatment
of obsessive compulsive disorder (OCD) in children and
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
Most commonly observed side effects included agitation,
hyperkinesia, depression, dysmenorrhea, flatulence and rash.
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.