The decision, which covers children and teens seven to 17 years of age, marks the first approval of one of the newer types of antidepressants -- called selective serotonin reuptake inhibitors, or SSRIs -- for treating depression in children.
Depression affects up to 2.5 percent of children and up to 8.3 percent of adolescents in the United States. Obsessive-compulsive disorder, or OCD, affects about two percent of the population, and typically begins during adolescence or childhood. At least one-third of the cases of adult OCD begin in childhood, the National Institute of Mental Health says.
Clinical trials revealed that the side effects of Prozac use in children and teens were similar to those typically experienced by adults, including nausea, tiredness, nervousness, dizziness, and difficulty concentrating, the FDA says.
However, one trial in children and adolescents eight to 17 years old found that after 19 weeks of treatment with Prozac, the study participants gained, on average, about a half an inch less in height and about two pounds less in weight compared to children taking a placebo.
The drug's maker, Eli Lilly, has agreed to conduct a follow-up study to further evaluate any potential impact of Prozac's use on long-term growth in children, the FDA says.