FDA issues new rules to make children's drugs safer

The U.S. Food and Drug Administration wants to make it a little harder for the medicine to go down. Over-the-counter children's medicine, that is, such as cough syrups, pain relievers, and cold remedies. It has released new guidelines saying such remedies should include a device that helps minimize the risk of overdose.

Most OTC liquid medicines do come with a "dosage delivery device"—plastic cups, droppers, and spoons, for examples. But the new FDA guidelines specifically recommend to drug makers:

• 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.

"Accidental medication overdose in young children is an increasingly common, but preventable public health problem," said Karen Weiss, M.D., program director for the Center for Drug Evaluation and Research's Safe Use Initiative.

Drug makers also recently took a related step toward reducing accidental overdoses.

The Consumer Healthcare Products Association (CHPA) announced that drug makers will offer liquid acetaminophen medicine ("liquid Tylenol") for children under 12-years old in only one strength: 160-mg per 5-mL. The other more concentrated, versions (80 mg per 0.8 mL and 80 mg per 1.0 mL) for infants will no longer offered. Instead, new liquid acetaminophen for infants will include syringes to help deliver the right amount of medicine.

The FDA urges that even with the new guidelines, parents and caregivers should continue exercise caution when giving children any type of medication. Check out their 10 tips to follow when giving medicine to an infant or child.

See Consumer Reports on Health and our section on Babies & Kids for more advice.

10 tips when giving medicine to an infant or child (PDF) [US FDA]
Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications [US FDA]
OTC Industry Announces Voluntary Transition to One Concentration of Single-Ingredient Pediatric Liquid Acetaminophen Medicines [CHPA]

—Paul Eng