Special Report

Pediatric Prozac

Thanks to the FDA, Ritalin doesn't have to be your child's only drug of choice.

4.29.03

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Is your child depressed, rambunctious, or, God forbid, hyperactive? Don't despair, the U.S. Food and Drug Administration will approve a drug for just about every childhood problem -- now more commonly known as disorders. For kids who are not on Ritalin, there is help for you too. On January 3, 2003, the FDA approved the use of Prozac for children ages 7 to 17. Prozac, it claims, can be effective in treating depression and obsessive-compulsive disorder in children.

Unfortunately, the FDA made this decision based on only two studies. The first, involving 96 children, was conducted by the University of Texas Southwestern Medical Center at Dallas, and was funded by the National Institute of Mental Health. According to the Southwestern Medical Center's press release, "Prozac is a selective serotonin reputake inhibitor and is thought to work by increasing serotonin in the brain." Thought to work? To a parent, that can't sound very reassuring. The second study, involving approximately 200 children, was conducted by Eli Lilly, the drug manufacturer. It is perhaps cynical but nonetheless interesting to note that the sale of Prozac has suffered since the manufacturer, Eli Lilly, lost its patent protection in August 2001. Coincidentally, the FDA has made no determination regarding the use of a generic version of Prozac for pediatric use. The over-prescription of drugs to children in the United States is a growing concern, especially when the long-term effects are unknown. These concerns, however, do not appear to have any influence on the FDA or drug manufacturers.

The National Institute of Mental Health website warns of the danger of medicating young children: "Young children's bodies handle medications differently than older individuals and this has implications for dosage. The brains of young children are in a state of very rapid development, and animal studies have shown that the developing neurotransmitter systems can be very sensitive to medications. A great deal of research is still needed to determine the effects and benefits of medications in children of all ages." One of the results of the Prozac studies relates to the growth effects on children. After 19 weeks on the drug, children grew one-half inch less than those who were treated with a placebo. But parents can rest easy because Eli Lilly has promised to conduct a study to determine what the impact will be on long-term growth. In addition to stunting growth, children on Prozac experience numerous other side effects such as nausea, tiredness, nervousness, dizziness, and difficulty concentrating.

Psychiatric drugs such as Prozac and Ritalin will continue to be prescribed by primary care physicians, and the FDA approval will certainly increase those numbers, perhaps significantly. In January, the Los Angeles Times reported that this is exactly what some physicians are worried about. According to Dr. Charles Grob, director of the division of child and adolescent psychiatry at Harbor-UCLA Medical Center in Torrance, "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." Before these powerful drugs are prescribed, there should be some method developed to protect children who may very likely be misdiagnosed.

Dr. Julie Magno Zito, of the University of Maryland, conducted a survey regarding the treatment of children with psychiatric disorders. According to Dr. Zito, in 1987 only 2.5 percent of American children had taken a psychiatric drug. In contrast, 6.2 percent of American children took at least one psychiatric drug in 1996. It was also noted that there is no parity between boys and girls. In fact, boys were treated at twice the rate of girls. With the increase in drugs on the market to treat every imaginable disorder known to mankind, our children are in danger of receiving medication whenever they admit to having feelings.

The National Institutes of Health is currently conducting clinical trials regarding the treatment of "Childhood Social Phobia," more commonly known as shyness. This "Social Effectiveness Therapy for Children (SET-C)" is treated with Fluoxetine, the generic Prozac. This, of course, should not be confused with the clinical trial for "Child and Adolescent Anxiety Disorders," which are treated with Zoloft. The National Institute of Mental Health is also sponsoring clinical trials right now to study the effects of drugs like Prozac on children who suffer from Social Anxiety Disorder (SAD), Generalized Anxiety Disorder (GAD), Child and Adolescent Anxiety Disorders (CAAD), and Major Depressive Disorder (MDD). Considering that so many of our children are suffering from so many disorders -- pass the Prozac please, the adults are going to need it.

Dariel A. Colella is a writer in Wilton, Connecticut.

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