Citing the “serious potential” for overdoses with children’s liquid over-the-counter remedies, the Food and Drug Administration has issued packaging guidelines intended to make it easier to follow medicine instructions.
Accidental overdoses have been linked to such items as cups and droppers that are packaged with the medicines but that confuse consumers because their measurement markings are misleading or their sizes are inappropiate. Regulators say bad packaging also can prompt parents to use less accurate devices, such as household spoons, leading to further dosage errors.
“Accidental medication overdose in young children is an increasingly common, but preventable public health problem,” Dr. Karen Weiss, program director for the FDA’s Center for Drug Evaluation and Research’s Safe Use Initiative, said in a news release.
According to a study published in the Journal of the American Medical Association last year, about a quarter of over-the-counter liquid drugs do not come with a measuring device. Among the medicines that were packaged with a measuring device, almost all had at least one mismatch between the markings on the device and the written dosing directions.
The FDA is recommending that:
- Dosage devices should be provided with all OTC liquid drugs.
- Units of measurement marked on the dosage device should square with the measurement units on the label.
- If an abbreviation of a measurement unit is used on the dosage device — for example, “tsp” for “teaspoon” — the abbreviation on the label should be the same.
Dr. Darren A. DeWalt, an associate professor at the University of North Carolina School of Medicine, told CNN that more needs to be done to prevent overdosing but “the FDA is a little bit stuck because of a lack of research to tell us exactly how to make the [best] labels.” One manufacturer, Johnson & Johnson, has responded to the problem by introducing a dose-limiting cap.
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