Medical News: FDA Lays Out Rules for OTC Liquid Meds - in Washington-Watch, FDA General from MedPage Today

Medical News: FDA Lays Out Rules for OTC Liquid Meds - in Washington-Watch, FDA General from MedPage Today

WASHINGTON -- The FDA's new guidance for companies that make over-the-counter liquid medications -- such as cough syrups and cold remedies -- calls for packaging with calibrated dosing devices to prevent accidental overdose. Most liquid medicines already come with a dosing device, such as a cup or a dropper, but the FDA would like every liquid drug sold over-the-counter to have a measuring device, according to a final guidance issued by the agency. Those dosing devices should be clearly marked with liquid units of measurement, such as teaspoon or tablespoon, and the unit of measurement on the cup or spoon should be the same unit of measurement listed on the directions for use. The dosing device should also not carry any unnecessary markings that might be confusing to the person measuring out the dose, and the markings should stand out enough so they aren't obscured once the liquid product is added. Several recent studies have indicated that children often receive improper doses of liquid OTC medicines because parents give them in household spoons, or because the included dosing devices are poorly marked. One study found that cups included with liquid medications were particularly prone to errors, with some 70% of parents putting more than 6 mL of liquid into a cup intended for dispensing 5 mL. "Accidental medication overdose in young children is an increasingly common but preventable public health problem," said Karen Weiss, MD, of FDA's Center for Drug Evaluation and Research's Safe Use Initiative, in a press release. Overdoses of acetaminophen are among the most frequent unintentional poisonings seen in emergency departments and can lead to acute liver failure. Following the FDA's announcement, the trade group Consumer Healthcare Products Association (CHPA), announced OTC drug manufacturers will no longer produce liquid acetaminophen in a concentrated dose for infants, and liquid acetaminophen products for children under 12 will be sold only in one concentration to avoid confusion and accidental overdose. Manufacturers will also be adopting syringes with dose restrictors for products intended for infants, the CHPA indicated, but cups will continue to be provided for older children. In 2008, the FDA held a public hearing where consumer groups and some pediatricians -- including Joshua Sharfstein, MD, who was then Baltimore Health Commissioner and went on to become deputy commissioner of the FDA -- called for the FDA to ban the sale of over-the-counter cough and cold medicines for young children. Industry groups argued that the drugs are safe for use in kids under 2 years old. Some at the meeting also complained about the confusing dosing and labeling on kids' cough and cold products. The FDA's new recommendation also lists tips that caregivers should follow when giving medicine to a child, including knowing the child's weight, the difference between a tablespoon and a teaspoon, and using the dosing tool that comes with the medicine.