FDA approves Prozac for children

By The National Psychologist Editor
March 1, 2003 - Last updated: May 31, 2011

Despite no studies showing what the long-term effects are on children, but with evidence indicating short-term loss in growth, the Federal Drug and Drug Administration has nonetheless approved Prozac to treat children and adolescents.

The approval to prescribe the drug to children from ages 7 and 17 for treatment of depression follows two placebo-controlled clinical trials in children.

The January announcement marks the first time the FDA has approved the use of a selective serotonin reuptake inhibitor for this age group.

The drug was also approved for the treatment of obsessive compulsive disorder, the third such class of drugs to win FDA backing. About 2% of the population suffers from obsessive compulsive disorder, with one-third of those cases beginning in childhood.

Prozac, probably the best-known anti-depressant on the market, has been prescribed for children for years despite never having been approved by the federal government. Placing child-specific information on Prozac’s FDA-mandated label means more doctors, not just psychiatrists and others specializing in the treatment of depression, may begin to prescribe the drug.

In one 19-week clinical trial, children and adolescents 8 to 17 years old taking Prozac gained about less than half an inch in height and about two pounds less in those treated with placebo, the FDA reported.

The agency said Eli Lilly, the manufacturer of Prozac, has agreed to do long-term studies on the effects the drug has on children.

Children in the tests suffered the same side effects that adults who take Prozac do, including nausea, tiredness, nervousness, dizziness and difficulty concentrating.

Stephen Henshaw, Ph.D., a child psychologist at the University of California at Berkeley, said that only recently has it been shown Prozac was any more effective in treating depression among teenagers and younger children than a sugar pill.

For years, it was thought that children did not suffer from depression, a belief that was reinforced with the success of placebos in treating them. However, Henshaw said, Prozac should not be viewed as a magic pill for this group of depression suffers, any more than for adults.

He said there’s no reason to question earlier findings that the best treatment for any mental disorder is a combination of drugs and therapy, despite the fact that managed care encourages the use of drugs and discourages therapy.

”The evidence shows that there is significant benefit in combining drugs and therapy. The combination works better than either drugs or therapy alone. If this is true for adults, it’s bound to be true for children,” Henshaw said.

Still, other psychologists thinks it’s a mistake to give children and adolescents drugs.

Jeffrey A. Schaler, Ph.D., of Silver Spring, Md., said he understands the appeal that drugs such as Prozac has for adults with children.

”It sure beats the difficult job of parenting,” Schaler said. “The problem is that taking a pill doesn’t solve the problem.”

He said kids are prohibited by law from taking illegal drugs that make them feel better and forced to take medications to make them feel better.

”It’s enough to make you want to take a drug,” he said.

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