Archives: FDA Approves Prozac for Pediatric Use to Treat Depression and OCD

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[sSRI-Research] Archives: FDA Approves Prozac for Pediatric

Use to Treat Depression and OCD

 

 

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FDA Approves Prozac for Pediatric Use to Treat

Depression and OCD

http://depression.about.com/gi/dynamic/offsite.htm?site=http://www.fda.gov/bbs/t\

opics/ANSWERS/2003/ANS01187.html

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.

 

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