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Posted at 7:30 AM ET, 12/ 1/2010

Concerns about kids' medicines

By Rob Stein

New research is rekindling concerns about the safety of some popular over-the-counter liquid medications for children.

H. Shonna Yin of the New York University School of Medicine and colleagues studied the dosing directions and measuring devices provided for 200 top-selling pediatric liquid medications sold without a prescription, including treatments for coughs and colds, allergies and stomach problems. The researchers say they found the instructions on boxes and bottles were often confusing and hard for parents to follow, putting children at risk.

A standardized measuring device was provided for 148 of the products, and nearly all of them -- 98.6 percent -- contained one or more inconsistencies between the labeling direction and the accompanying devices, the researchers report in a paper that will be published Dec. 15 in the Journal of the American Medical Association. About a quarter did not include dosing devices such as cups or droppers, the researchers found, and nearly a quarter lacked necessary markings. In some cases, the instructions used abbreviations that were not defined.

In 2007, leading manufacturers of cough and cold medicines for children pulled products from the market amid rising concerns about the safety of the popular remedies. That episode focused attention on the safety of many medications for children. In November 2009, the Food and Drug Administration released voluntary guidelines that companies should use for how to sell over-the-counter liquid medications for kids. The move came after the agency received reports of children being accidentally overdosed, in part because of inconsistent or confusing labels and measuring devices.

The new study began Nov. 6, 2009, and continued through February 2010.The researchers say they hope they will help evaluate how well the industry responded.

In an editorial accompanying the study, Darren DeWalt of the University of North Carolina at Chapel Hill said the findings illustrate that more needs to be done to help parents administer medications to their children safely.

In a statement, the Consumer Healthcare Products Association, which represents companies that make such medications, said that the group "takes very seriously its responsibility to help parents and caregivers safely and correctly administer ... pediatric oral medicines to children."

The group said it issued its own voluntary guidelines in November 2009 in consultation with other organizations, including the federal Centers for Disease Control and Prevention and the American Association of Poison Control Centers.

By Rob Stein  | December 1, 2010; 7:30 AM ET
Categories:  FDA  
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