Wednesday, October 15, 2008

Prozac on the Playground - The dangers of off-label use of psychiatric medications in children.

Problem: We are now more aware of emotional illness in children and much more likely to diagnose and treat conditions like attention deficit disorders. But as difficult and expensive as it is to test new medications on adults, it's even harder to do the testing on children. Many treatments applied to children reflect "off-label" use of medications that have been specifically approved for adults—but not for kids. When the FDA grants a license to a new prescription medication, it lists its permitted uses ("indications") and the patients for whom it is intended (including their age range), usually reflecting the population it was tested on—children with strep throat, women with breast cancer. If a drug company even mentions a use not specifically approved, it has violated FDA rules and can be fined or otherwise punished. However, once a drug has received FDA approval, physicians are free to use it for applications or populations for which it was not formally approved. After (usually adult) FDA approval has been obtained, manufacturers often don't bother with expensive testing that would allow them to request a label extension for use in kids, since they'll have the (off-label) market, anyway. Off-label use accounts for somewhere between half and three-quarters of all medications used in children and is also commonly used for adult treatment. Pediatricians are often uncomfortable with this practice, but they consider it the lesser of two evils when confronting an illness with effective adult treatment but nothing for children. Most medications behave similarly in children and adults, but that rule has exceptions, as we sometimes discover too late. Aspirin can lead to a horribly dangerous liver and brain disease in children or teens. Tetracycline, a common antibiotic, can damage the teeth of children under 8 years old. The problem is particularly troublesome when it comes to prescribing psychiatric medications to kids, which is increasingly common.


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