An emerging study has revealed some disturbing news about how children’s medicines are explained, resulting in dosing problems in most over-the-counter (OTC) medications geared to children. According to WebMD, the study suggests that instructions on how to dose OTC liquid medications for children “are often confusing, inconsistent, and hard for parents to follow.†The team […]
An emerging study has revealed some disturbing news about how <"https://www.yourlawyer.com/practice_areas/defective_drugs">children’s medicines are explained, resulting in dosing problems in most over-the-counter (OTC) medications geared to children.
According to WebMD, the study suggests that instructions on how to dose OTC liquid medications for children “are often confusing, inconsistent, and hard for parents to follow.†The team looked at 200 of the top selling liquid cough and cold, allergy, pain, and stomach products made for children, specifically reviewing packaging information, said WebMD. The study followed release of voluntary packaging guidelines issued by the U.S. Food and Drug Administration (FDA) last year, WebMD added.
The new guidelines require OTC liquid medicines include a measuring device for dosing and for consistency between directions on the devices and labeling, including that the same abbreviations and measurement units be used throughout, wrote WebMD.
The report, which was published online yesterday, points to the enormity of the problem, including that one-quarter of all liquid medications reviewed did not come with any dosing device (cup, dropper, syringe); most—99 percent—of the medications contained markings on the device that were not consistent with the included directions; and more than half did not use standard abbreviations for significant terms, including teaspoon and milliliter, wrote WebMD.
Study co-author Ruth Parker, MD, of Atlanta’s Emory University School of Medicine, said in a news release that it is doubtful that the voluntary guidelines offer adequate instruction. “The current guidance does not contain a timeline for compliance or specify consequences for non-compliance,†wrote Dr. Parker. “Standards and regulatory oversight will likely be needed to ensure that all products contain label information and dosing device markings that match and are understandable and useful,†quoted WebMD.
No small issue given that more than half of all U.S. children take one or more medicine weekly, with more than half of these medications being OTC drugs, said the research team, wrote WebMD.
In October 2007, some drug makers removed infant versions of medications off the market, including Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand; Pediacare, Dimetapp, and Little Colds brand products were also recalled. Earlier last year, the FDA issued a warning advising that OTC cold and cough medicines should not be given to children under two following a 2007 study conducted by the Centers for Disease Control that found that between 2004 and 2005, 1,500 children under the age of two were injured by common OTC decongestants and antihistamines; a second study by FDA safety reviewers reached similar conclusions and that research revealed that from 1969 to 2006, at least 54 children died after taking OTC decongestants, and 69 died after taking OTC antihistamines.
