FDA Moves to Reduce Accidental Overdoses of OTC Drugs

The Food and Drug Administration today announced new guidelines for calibrated cups, droppers, syringes, and spoons used to deliver over-the-counter cold and flu treatments and other medications, which may be confusing or misused and result in accidental drug overdoses.

Non-prescription cold remedies, particularly those intended for young children, commonly are administered using dosing cups, spoons, or droppers provided in the packaging. However, unclear or inconsistent dosing instructions for the drugs can result in accidental overdoses, the FDA said.

For example, some drug packages have dosing instructions that give the proper dose in a different measurement than is used on the dosing cup or dropper, which can lead to confusion over the proper dose to be given.

New FDA Guidelines Aim To Reduce Accidental Overdoses

A new guidance document, called “Dosage Delivery Devices for OTC Liquid Drug Products,” was posted online today as part of the FDA’s new Safe Use Initiative.

“This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications – the safest and most effective dose – especially for children.”

Each year in the United States, millions of children and adults are injured by improper use or incorrect doses of approved medications, the FDA said. In many cases, a lack of sufficient dosing information or dosing instructions which are unclear or inconsistent result in the improper and potentially dangerous dose being given.

FDA Recommends Safety Changes

Among the FDA’s new safety recommendations for over-the-counter drug dosing information:

• Delivery devices provided in the drug’s packaging should have calibrated units of measure marked on the device that are the same as the units of measure specified in the labeled dosage directions on any outside packaging (carton labeling), bottle, and any accompanying written instructions.

• If units of measure are abbreviated on the dosage delivery device, the abbreviation used on the device should be the same abbreviation used in the labeled dosage directions, outside packaging (carton labeling), bottle, and any accompanying written instructions.

• Any decimals or fractions included on dosage delivery devices should be listed as clearly as possible.

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