Panel votes 20-0 for reformed labeling of kids’ pain & fever relieving medication

By Dr. Ananya Mandal, MDMay 19 2011

A federal advisory panel unanimously recommended that dosing for children's acetaminophen be based primarily on the child's weight rather than age. At present the dosing for children's products including acetaminophen- best known by the brand name Tylenol- is based on age, although many labels also contain information on dosing by weight as well. Acetaminophen is the most commonly used medicine meant to lower fever and relieve pain in children.

Now this panel for the Food and Drug Administration has come up with recommendations that a standard label be used for all acetaminophen products. It also recommended that any age-associated weight tables be updated to reflect the increase in the average weight of children over the past two decades.

In order to reduce the risk of overdoses, Tylenol maker Johnson & Johnson, along with acetaminophen makers Perrigo Co. and Novartis AG, decided voluntarily to discontinue a more-concentrated formula used in infant-drop products, and instead use the same liquid concentration of acetaminophen for both infants' and children's products. An FDA panel recommended a single infant and children's formulation in 2009. Companies said new single-formulation acetaminophen products would become available starting this summer, and existing products won't be removed from the market. The panel said the FDA should consider requiring a single concentration of solid forms of acetaminophen for children as well. There are two different strengths of chewable products on the market, as well as two strengths of tablets.

The FDA added that from 2000 to 2010 it received reports of 14 fatal and 74 non-fatal adverse events related to acetaminophen medication errors in infants and children ages 13 and younger. Some of the fatal reports were caused by parents using the more-concentrated infant drops in amounts meant for older children. The panel also voted 21 to 0 in favor of adding dosing instructions for infants as young as six months onto children's liquid products. Current children's acetaminophen formulations provide dosing information for children from the ages of 2 years to 12 years, with instructions to “ask a doctor” for children younger than 2.

The FDA is expected to adopt many of the panel's recommendations as part of likely changes to over-the-counter drug regulations for dosing and packaging. The panel meeting is part of an ongoing FDA effort to address acetaminophen's safety. Exceeding recommended doses of acetaminophen is one of the leading causes of liver failure.

Earlier this year, the FDA asked makers of prescription products that combine acetaminophen with another ingredient, such as oxycodone or hydrocodone, to limit the amount of acetaminophen to no more than 325 milligrams per tablet. To cap over-the-counter acetaminophen at the same strength, the FDA would have to go through a lengthy federal rule-making process

The final recommendation may involve;

• Label dosing instructions for children ages 6 months to 2 years
• Modify the bottles so that children cannot get to it.
• Add measuring device clearly marked in milliliters using the standard "mL" abbreviation.
• All solid, pill forms of acetaminophen for children to come in the same concentration. Previous panels already recommended this for liquid formulations of acetaminophen.

The Consumer Healthcare Products Association said in a statement following the decision that it supported the recommendations to “give parents and caregivers more accurate and detailed dosing information where it is needed — directly on the drug facts label.” In Canada, the concentration of acetaminophen and dosing directions for pediatric products is regulated by Health Canada. The labeling standard governing these products in Canada was updated in late 2009.