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Another risk for kids ­ lots of them on Prozac

By Joyce Howard Price
Hundreds of thousands of American children as young as preschoolers are taking Prozac and other mood-altering drugs that have been approved only for adults and have undergone little or no pediatric testing.
     From 1996 to 1997, the number of children ages 5 and under taking the most commonly prescribed anti-depressants climbed from 8,000 to 40,000, according to IMS Health, a pharmaceutical research firm in Plymouth Meeting, Pa.
     During that same 12-month period, the total number of youngsters 17 and under who were prescribed Prozac or its primary competitors, Zoloft and Paxil, rose by more than 120,000 -- from 669,000 to 792,000, IMS Health said.
     Dr. Donald L. Rosenblitt, medical director of the Lucy Daniels Center for Early Childhood, a "therapeutic nursery" in Cary, N.C., says it's not rare for doctors to prescribe those drugs for children as young as 4.
     "They are doing it more and more, probably more often than I'm comfortable with," Dr. Rosenblitt said in a telephone interview.
     He added there is no information yet on the "long-term effects [of these drugs] on the developing brain."
     "The enormous weight of evidence, so far, is that anti-depressants do not help childhood depression," Dr. Rosenblitt added.
     The National Institute of Mental Health estimates that as many as 1.5 million children and adolescents -- 2.5 percent of all Americans under age 18 -- are seriously depressed. The American Academy of Child and Adolescent Psychiatry puts the number of "significantly" depressed children and adolescents at 3.4 million.
     Even child psychiatrists who believe these drugs can be valuable treatments for depressed children acknowledge the need for more study on their effects. The medications raise the level in the brain of a mood-regulating chemical, serotonin.
     "There's still a lot we don't know about using these medications in kids," said Dr. David G. Fassler, a Vermont psychiatrist and chairman of the American Psychiatric Association's Council on Children, Adolescents and their Families. "We don't know about their long-term effects. Children are not just small adults."
     Dr. Graham Emslie, a psychiatry professor at the University of Texas Southwest Medical Center in Dallas, stresses the need for caution. He has tested the effectiveness of Prozac and Paxil in two eight-week studies -- one involving less than 100 depressed children ages 8 to 18, and another focusing on 275 depressed teens.
     "These newer anti-depressants have substantially fewer side effects than the older ones, but I don't think they are benign," Dr. Emslie said.
     Dr. Rosenblitt says agitation and nervousness are common side effects in children and others who use Prozac. But he stresses that complications can be far more severe in seriously troubled youngsters.
     "I've seen some disturbed children who've become psychotic," or deranged, after taking Prozac, he said. He added that the drug "precipitated psychotic panic" in those children.
     But Dr. Fassler said there is no evidence Prozac contributes to violence, commenting on reports that Kip Kinkel, the 15-year-old Oregon youth who opened fire on classmates in the school cafeteria, had formerly taken Prozac.
     The Food and Drug Administration has approved Prozac, Paxil, and Zoloft only for use in adults, although it's legal for doctors to prescribe them for children.
     "If we approve a drug for depression in adults, we know it will be applied in kids" as well, said Dr. Thomas Laughren, FDA team leader for psychiatric drug products.
     He said only a "handful of studies" exist of these medications in children, despite stepped-up federal pressure on drug companies to test the products in youth.
     Dr. Laughren is part of an FDA group working on rules that would require manufacturers to conduct more studies on the effects of drugs like Prozac on children, and force them to put child-appropriate dosages on labels.
     The rules, proposed by Mr. Clinton nearly a year ago, would attempt to eliminate what the president described as doctors guessing about proper doses for children.
     Dr. Laughren said the rules have "met with resistance from drug companies," who cited the costs and difficulties of testing children.
     But Dr. John Siegfried of the Pharmaceutical Research and Manufacturers of America said Congress made the idea of pediatric testing far more palatable with FDA reform legislation passed late last year.
     "The FDA law grants companies an additional six months of product [patent] exclusivity if they do pediatric testing and define dosages" for children, he said.
     Dr. Siegfied said Prozac is not the only drug that is used for children without age-specific testing. "Only 20 percent of the drugs used in kids have been tested in kids, but that doesn't mean the other 80 percent are being used inappropriately," he said.
     Dr. Emslie's Prozac study, which involved 96 children, was the first to indicate that anti-depressants could help children. His federally funded research showed that 56 percent of depressed children given Prozac showed improvement, compared with only 33 percent of those who took a placebo.
     Dr. Rosenblitt said that although this single study suggests anti-depressants could alleviate childhood depression, "there have been many other studies that did not show that."
     However, Dr. Emslie reported the same results in his larger, more recent study that compared the effectiveness of Paxil with that of a placebo among adolescents. The study found Paxil about 20 percent more effective than sugar pills, he said.
     Moreover, Dr. Emslie, Dr. Fassler and other child psychiatrists note a wealth of anecdotal and clinical experience with these drugs in children. But they stress that drugs should be a component of treatment, not the only therapy.
     "About half of the kids in our practice get medication as part of their treatment. It's never appropriate to use it alone," said Dr. Fassler, co-author of a book on childhood depression titled, "Help Me, I'm Sad."
     He says childhood depression is a "medical illness like cancer and diabetes, but it's more treatable than those diseases." He says treatment for childhood depression is effective for 70 percent to 80 percent of children.
     The FDA's Dr. Laughren sees the Emslie studies on Prozac and Paxil in children as "very positive findings," but adds, "We'd like to see more studies."
     Jeff Newton, spokesman for Eli Lilly & Co., which makes Prozac, said the company started clinical trials in children last spring.
     "The FDA feels we need more data. Patient groups feel we need more data, and we do as well," he said.
     He declined to say how many children are participating in the trials or give their ages, citing competitive concerns.
     Asked about reports that Prozac can accumulate in a patient's system, Dr. Laughren of the FDA said the drug "has a fairly long elimination half-life, so you do get accumulation" of the drug and its byproducts in the body, "and it takes a long time" to get rid of them.
     He said some studies that have looked at levels of Prozac in the brain and other parts of the central nervous system have found its presence "many months" after a patient stops taking it.
     Dr. Laughren stressed that Prozac is not unique in that respect, and that its long elimination half-life is not a problem in and of itself. But he acknowledged that the "long time it takes to clear the drug can mean problems" for those who experience complications from Prozac.

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