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FDA Approves Prozac For Pediatric Use To Treat Depression, Obsessive Compulsive Disorder

BETHESDA, MD -- January 6, 2003 -- The Food and Drug Administration has approved new uses for the antidepressant Prozac (fluoxetine) to treat children and adolescents seven to 17 years of age for depression (major depressive disorder) and obsessive compulsive disorder (OCD). This is the first approval of one of the newer types of antidepressants (selective serotonin reuptake inhibitors or SSRIs) for treating depression in this population.

According to the National Institute of Mental Health (NIMH), depression affects up to 2.5 percent of children and about eight percent of adolescents in the United States. OCD affects about two percent of the population, and typically begins during adolescence or early childhood. At least one-third of the cases of adult OCD began in childhood. The social and economic costs of OCD were estimated to be $8.4 billion in 1990.

Today's approval of Prozac for use in children and adolescents was based on two placebo controlled clinical trials in depressed outpatients whose diagnoses corresponded to standard rating criteria (under the American Psychiatric Association's Diagnostic and Statistical Manual). Symptoms of depression include general emotional dejection, withdrawal and restlessness that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood; loss of interest in usual activities; significant change in weight and/or appetite; insomnia or hypersomnia (abnormally excessive sleep); psychomotor agitation or retardation; increased fatigue; feelings of guilt or worthlessness; slowed thinking or impaired concentration; a suicide attempt or suicidal ideation.

The studies of Prozac for depression produced a statistically significant effect for the drug compared to placebo on the "Childhood Depression Rating Scale R (revised)."

In children with OCD between the ages of seven and 13 and adolescents 13 to 18, Prozac produced a statistically significant result compared to placebo on a measurement called "The Children's Yale Brown Obsessive Compulsive Scale." Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are repetitive and purposeful, and intentional behaviors (compulsions) that are recognized by the person or their parent or guardian as excessive or unreasonable.

Common side effects associated with use of Prozac in children and adolescents were similar to those experienced by adults and include nausea, tiredness, nervousness, dizziness, and difficulty concentrating. In one clinical trial in children and adolescents eight to 17 years of age, after 19 weeks of treatment with fluoxetine, pediatric patients gained, on average, about 1.1 cm less in height (about a half an inch) and about one kg. less in weight (about two lbs.) compared to pediatric patients treated with placebo. The clinical significance of this observation on long-term growth is unknown. Lilly has agreed to conduct a Phase 4 postmarketing study to further evaluate any potential impact of fluoxetine on long-term growth in children.

Prozac is marketed by Eli Lilly, of Indianapolis, Ind., and is also approved for major depressive disorder in adults, bulimia, and panic disorder.


SOURCE: FDA

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