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Most Medications Untested For Pediatric Use, Still Prescribed

Armen Hareyan's picture

The Baltimore Sunon Tuesday examined how "adult drugs are routinely prescribed forchildren despite" the fact that most have never undergone clinicaltesting for children, "forcing physicians to sometimes use a best guessin determining dosing, efficacy and even safety."

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The Government Accountability Office this year said that one-third of drugs prescribed for children have undergone pediatric testing. Drugs approved by FDA for use in adults "can be legally prescribed to anyone," the Sunreports. However, data from clinical trials to determine proper doses,effectiveness and side effects "applies only to full-grown adults, notchildren whose brains are still developing, who are still growing andwhose body chemistry is immature," according to the Sun.

Pediatricstudies that have been conducted -- mostly involving older drugs --found that 87% were being prescribed to children improperly. Inaddition, children were receiving medications that were not effectiveand they were being overdosed and underdosed or exposed to previouslyunknown side effects, the Sun reports. Physicians say they prescribe drugs approved for adults to children because they have no alternatives.

A1997 federal law that was updated in 2002 provides incentives for drugmanufacturers to test drugs in children by granting the companies anadditional six months of patent protection, but drug makers are notrequired to conduct every study FDA requests. In addition, there "islittle incentive for drug companies to pay for studies on drugs thatare no longer under patent," the Sun reports. Congress has authorized NIHto pay for studies of older drugs, but has not yet funded them,according to Lori Reilly, vice president for policy and research at Pharmaceutical Research and Manufacturers of America (Desmon, Baltimore Sun, 10/16).

Reprinted with permission from kaisernetwork.org. Youcan view the entire Kaiser DailyHealth Policy Report, search the archives, and sign up for email deliveryat kaisernetwork.org/email. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.