Drugs Designed for Child Use
Many medications used in children are used “off-label” because appropriate studies have never been conducted so that they cannot be labeled by the U.S. Food and Drug Administration (FDA) for use in children. In an attempt to correct this, Congress permitted the FDA to extend marketing rights to companies if the companies would perform pediatric trials on these drugs. This is known as “pediatric exclusivity”. But has this worked to make pediatric information on drugs more available?
Literature search was conducted for studies on drugs that received pediatric exclusivity by the FDA. The investigators found 253 studies submitted to the FDA that evaluated the efficacy of the drugs in children (50%), dosage studies (33%), and safety studies (17%). As such, the program is successful in learning more information on these drugs for children’s use. Unfortunately, only half of these studies were published and the authors call for ways to disseminate this information.
(Benjamin DK, et al. JAMA 2006; 296(10):1266-1273.)
Comment. I know that when medications administered to children in school are not actually authorized for that age-group, it is a cause of discomfort for school personnel. Perhaps we are on the right track, now. – H.T.
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