The U.S. Food and Drug Administration (FDA) has issued a public announcement that another concentration of liquid acetaminophen marketed for infants (160 mg/5 mL) is available in stores. The new children’s acetaminophen dose may cause confusion.
Up until now, liquid acetaminophen marketed for infants was only available in 80 mg/0.8 mL or 80 mg/mL concentrations. This newly announced change in the medication’s concentration will affect the amount of liquid given to an infant, which can be confusing if one is accustomed to the 80 mg /0.8 mL or 80 mg/mL concentrations. The new liquid acetaminophen might be packaged with an oral syringe, not the traditional dropper.
This change was made, explained the FDA, following a June 29-30, 2009 joint meeting of the FDA Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee in which the issue of over-the-counter (OTC) liquid acetaminophen was discussed. A recommendation was made to have only one concentration of pediatric liquid acetaminophen available OTC because products with different concentrations can cause dosing confusion by parents and caregivers, which can lead to unintentional overdoses in pediatric patients.
Because of dosing errors with the concentrated acetaminophen formulation (80 mg/0.8 mL or 80 mg/mL), some manufacturers have voluntarily changed their liquid acetaminophen products marketed for infants to the same concentration (160 mg/5 mL) as acetaminophen products labeled for children. The change is voluntary, so products with prior concentrations marketed for infants might remain in stores and medicine cabinets. Availability for infant acetaminophen 160mg/5mL began earlier this year.
The FDA advises parents, consumers, and care givers to carefully read the package’s “Drug Facts” label to avoid confusion and potential dosing errors and to ensure they understand the directions, the concentration of liquid acetaminophen in mg/mL measurements, and the dosing device included with the product.
FDA has prepared a list of questions and answers which can be accessed at: http://www.fda.gov/Drugs/DrugSafety/ucm284756.htm, as well as a Consumer Update, which can be accessed at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm284563.htm. These online documents are meant to provide an additional overview of these changes.
The FDA noted that a concentration of 160 mg/5 ml of liquid acetaminophen marketed for “infants” is now available in stores and is less concentrated than other liquid acetaminophen products marketed for infants. Other products available are in 80 mg/0.8 mL and 80 mg/1 mL concentrations. Previous doses available were 80 mg/0.8 mL (dropper) and 80 mg/mL (dropper). Current doses available are 80 mg/0.8 mL (dropper), 80 mg/mL (dropper), and 160 mg/5 mL (oral syringe).
Because of their familiarity with it, many consumers aren’t aware that Tylenol and other forms of acetaminophen carry a risk of significant health affects, such as serious liver damage if too much is taken. Most recently, we wrote about links between acetaminophen and asthma and, now, research has found that taking even a little too much Tylenol over a few days can lead to fatal overdosing or so-called “staggered overdoses,” which occur when the daily recommended dose is repeatedly exceeded in small amounts. This differs from a single overdose in which a person takes too much medication in one dose.