Most Medications Untested For Pediatric Use, Still Prescribed

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Oct 2007 - 6:00 PDT

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The Baltimore Sun on Tuesday examined how "adult drugs are routinely prescribed for children despite" the fact that most have never undergone clinical testing for children, "forcing physicians to sometimes use a best guess in determining dosing, efficacy and even safety."

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 Sun reports. However, data from clinical trials to determine proper doses, effectiveness and side effects "applies only to full-grown adults, not children whose brains are still developing, who are still growing and whose body chemistry is immature," according to the Sun.

Pediatric studies that have been conducted -- mostly involving older drugs -- found that 87% were being prescribed to children improperly. In addition, children were receiving medications that were not effective and they were being overdosed and underdosed or exposed to previously unknown side effects, the Sun reports. Physicians say they prescribe drugs approved for adults to children because they have no alternatives.

A 1997 federal law that was updated in 2002 provides incentives for drug manufacturers to test drugs in children by granting the companies an additional six months of patent protection, but drug makers are not required to conduct every study FDA requests. In addition, there "is little incentive for drug companies to pay for studies on drugs that are no longer under patent," the Sun reports. Congress has authorized NIH to 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).

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