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Prozac Approved for Depression, Obsessive-Compulsive Disorder in Children

Posted by Staff Writer
Friday, January 03, 2003 12:00 AM EST
Category: Major Medical
Tags: Defective Drugs, Antidepressants and Other Psychiatric Drugs, Prozac, Fluoxetine Hydrochloride

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 25 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.

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 a 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 has also been linked to agressive and violent behavior.

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

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