Why are adult medications used to treat pediatric bipolar disorder?
When the Food and Drug Administration (FDA) approves a new drug, it also approves the instructions for the labeling based on data submitted by the drug company that show the drug worked better than a sugar pill in at least two studies. Clinical trials usually study adults. and therefore the labeling is for adult use only, making many drugs “off label” for children. Physicians are allowed to prescribe “off label” if the medication is given to a different age group, such as prescribing a medication FDA approved for adults to children. Many of the most commonly used drugs in adults across medicine have never been studied in children. Studies in children require the assent of the child, which is usually no problem as these forms are written in age appropriate language. The more difficult problem in conducting studies of children is simply the complexity, as both parents and the little patients need to be interviewed and need to be included in the procedures. Thus, studies of the child age
