FDA: Mandates Kids-Only Trials For Antidepressants
Federal regulators are taking the first steps in requiring drug companies to test popular antidepressant drugs for their long- term effects on children. The Food and Drug Administration is "preparing regulations that will require drug manufacturers to study the long-term effects of a wide range of medications" in children, the San Jose Mercury News reports. However, with or without testing, "health experts say the number of children taking antidepressants will continue to rise." With up to 1.5 million children and adolescents suffering from depression in the United States, the number of prescriptions for popular drugs, such as Prozac, are rising each year, with "200,000 in the past year just for the top four new medications."
However, there is concern that many children are taking the drugs without the benefit of long-term testing. "Physicians routinely use the anecdotal evidence that a drug works well in children to justify giving it, even though ... no one even knows for sure that depression in children is the same disease that it is in adults," said Graham Emslie, child psychiatrist at the University of Texas Southwestern Medical Center. Short-term studies of Prozac and Paxil have indicated that they are safe and effective in children, the Mercury News reports. However, "[u]ntil the proposed regulations go into effect -- which could take as long as a year or two, according to the FDA -- there is unlikely to be a significant increase in pediatric studies" (Sacks, 2/10).