The recent approval of Prozac for children and teenagers means more of them are likely to be treated for depression and obsessive-compulsive disorder. It also means that many could be treated inappropriately.
The Food and Drug Administration's decision to allow the drug to be prescribed for kids 7 to 17 will encourage more primary-care doctors, pediatricians and family-practice doctors to prescribe the antidepressant. That could especially benefit children who lack access to psychiatrists.
However, some psychiatrists caution that many children need both medication and psychotherapy and that some have mental illnesses masquerading as depression.
"If an internist or family doctor prescribes a medication like this, they're more likely to misdiagnose or inappropriately prescribe than would a well-trained psychiatrist," said Dr. Charles Grob, director of the division of child and adolescent psychiatry at Harbor-UCLA Medical Center in Torrance.
Although doctors have been prescribing Prozac to children and teenagers for years, until recently the drugs hadn't been studied for pediatric use. But that began changing when the Clinton administration began requiring manufacturers to test drugs on children as well as adults.
With the FDA decision, Prozac becomes the first of the selective serotonin uptake inhibitors approved for treating depressed children. Two antidepressants in the same class already have been approved for obsessive-compulsive disorder: Zoloft for children 12 and older and Luvox for children 8 and older. According to the FDA, about 2.5% of children and 8% of teenagers suffer from depression; obsessive-compulsive disorder affects about 2% of the overall population but often begins in youth.
The FDA based its decision on two studies that demonstrated Prozac was better than a dummy pill for children and teens with severe major depression. One study, conducted at the University of Texas Southwestern Medical Center at Dallas, followed about 100 children and teenagers. The other, sponsored by Prozac manufacturer Eli Lilly & Co., followed more than 200 at 20 sites, said Dr. James T. McCracken, chief of child and adolescent psychiatry at UCLA and one of the Eli Lilly study investigators.
Both studies found that kids generally had the same side effects as adults: nausea, fatigue, nervousness, dizziness and trouble concentrating.
However, at 19 weeks, kids in the Eli Lilly study who got Prozac were about a half-inch shorter and weighed 2 pounds less than those on the placebo. The FDA said the long-term significance of the observation wasn't known.
"It certainly is an observation that needs to be looked into more carefully," said McCracken, who stressed the need for research into the long-term safety and effects of these medications in children and teenagers.
McCracken said that other medications psychiatrists commonly prescribe to children for long periods -- such as Ritalin and Adderall for attention deficit hyperactivity disorder -- have "well-known growth effects, particularly on weight in the first year of continued treatment" that disappear with continued treatment or if they stop taking the medications. He said Prozac, which targets some of the same brain-signaling chemicals as Ritalin and Adderall, might have a comparable effect, although that would need to be shown in rigorous scientific studies.
"I don't think it's going to stop anyone from prescribing it," said Dr. Steve Sager, a child and adolescent psychiatrist at Childrens Hospital Los Angeles. "If a kid is struggling with depression and if that is affecting his psychosocial development, I'll look at the big picture and see the weight and growth issues as only one of the considerations."