Half of medications lack safety or dosing information for children

May 10, 2012

Reuters (5/9, Pittman) reports on a study published online in the Journal of the American Medical Association by researchers from the Food and Drug Administration finding after studying labeling of over 500 medications using the June 2009 electronic Physicians’ Desk Reference that half did not have adequate safety and dosing information for children. The researchers said that result was up from 20 percent of labels in 1975 having such information. The authors note the difficulties of doing research on children while noting that recent legislation and efforts by the National Institutes of Health have attempted to remedy some of those problems.

MedPage Today (5/9, Fiore) reports, “Only 46% had any information at all on pediatric use in their labeling.” The authors credit the Best Pharmaceuticals for Children Act (2002) and the Pediatric Research Equity Act (2003) as having “resulted in new pediatric labeling for almost 400 drugs as of March 2011.” They therefore call for their renewal.

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