Many 'Off-Label' Prescriptions Not Based on Science

It's fairly common for pediatricians to write "off-label" prescriptions, recommending medications that the Food and Drug Administration (FDA) hasn't approved for use in kids, or hasn't approved to treat specific conditions. Adult asthma medications, for instance, are used to treat asthma in kids. Or, based on studies and clinical trials, a doctor might prescribe an asthma medication to treat a different lung condition.

But a recent study sounds a warning on this practice. The study published in the Archives of Internal Medicine found that 73 percent of off-label prescriptions lack strong scientific justification, meaning there's a greater chance they will be ineffective - or even dangerous.

To help parents draw their own conclusions about the safety of medications prescribed to their children, Randall S. Stafford, M.D., Ph.D., assistant professor of medicine at Stanford University and a co-author of the study, suggests asking a few key questions of your child's doctor:

  • "Is this medication approved to treat my child's condition in children my child's age?"
  • "Has this drug been studied in children?"
  • "Have we exhausted the standard, approved treatments for this condition?"
  • "How good is the evidence that my child will benefit from this medication given his or her specific clinical situation?"

In some cases, there will be justification for the prescription. In others, you might want to ask for a second medical opinion.

Christina Elston is the contributing health editor for United Parenting Publications.

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