FDA Issues Dosing Guidelines for Liquid Medicines Used by Kids

The U.S. Food and Drug Administration has issued new guidelines for liquid medications used in kids. Over-the-counter children's medicines have recently come under the scanner due to reports of overdosing and the FDA has moved in quickly to regulate this area. “Accidental medication overdose in young children is an increasingly common but preventable public health problem,” said a released statement from Karen Weiss, MD, program director of the FDA’s Center for Drug Evaluation and Research’s Safe Use Initiative.

The guidelines issued by the FDA are as follows:
• Dosage delivery devices should be included for all orally ingested OTC liquid drug products
• Devices should be marked with calibrated units of liquid measurement (e.g. teaspoon, tablespoon, or milliliter) that are the same as the units of liquid measure specified in the directions for the product and there should not be any unnecessary markings.
• Manufacturers should ensure that dosage delivery devices are used only with the products they are packaged with.
• Liquid measure markings on dosage delivery devices should be clearly visible and not obscured when the liquid product is added to the device.

Consumers are also encouraged to report issues related to kids’ medicines to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.


Source-Medindia