Two FDA advisory committees, the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee–voted this week to recommend that dosing information for children 6 months to 2 years old be added to all over-the-counter children’s medicines containing acetaminophen, a change approved by doctors as well as the drug manufacturers. The meeting focused on liquid children’s medicines, which have never contained dosing information for children under 2 years of age, according to an article by Matthew Perrone, the Associated Press health reporter, in The Boston Globe of May 14, 2011. http://articles.boston.com/2011-05-14/business/29543541_1_dosing-acetaminophen-fda-policy
The FDA advisory committees held the two-day joint meeting in order to hear testimony from the Consumer Healthcare Products Association, McNeil Consumer Healthcare (manufacturer of Children’s Tylenol) and the AmericanAcademy of Pediatrics (AAP). This after years of parental and caregiver confusion over which and how much medicine to give young children, often due to confusing dosing language in medicine packaging.
Parents and caregivers will remember ChildSafetyBlog.org reported some children’s “cold” medicines were removed from the marketplace (more than once and for different reasons) during the past two years. The Consumer Healthcare Products Association now touts single-ingredient pediatric liquid acetaminophen medicines as “safe and effective” and recognized that parents and caregivers need information to dose the medicines appropriately “to make them most helpful for children.”
In his statement to the joint meeting, as reported by Caitlin Hagan of CNN, Dr. Daniel A.C. Frattarelli, chair of the American Academy of Pediatrics’ Committee on Drugs, said the AAP supports using weight-based dosing for children “because it is a better method” to determine the amount of medicine a child should receive. “Caregivers who understand that dosing should be based on weight rather than age are much less likely to give an incorrect dose.” http://www.kpho.com/print/27939504/detail.html
One recent study published in The Journal of the American Medical Association (JAMA) in November 2010, in response to unintentional drug overdoses of children by parents and caregivers administering over-the-counter children’s medicines found that there was a prevalence of inconsistent dosing directions and measuring devices among popular pediatric medicines. [Evaluation of Consistency in Dosing Directions and Measuring Devices for Pediatric Nonprescription Liquid Medications; H. Shonna Yin, Michael S. Wolf, Bernard P. Dreyer, Lee M. Sanders and Ruth M. Parker (JAMA. 2010;304(23):2595-2602. Published online November 30, 2010. doi: 10.1001/jama. 2010.1797.]
The FDA advisory committees also noted that parents have given their children the incorrect dose of medicine much of the time because the dosing instructions are confusing. While the committee members did not make any final recommendations, they discussed ways to improve the labels, including standardizing measuring units (millileters as opposed to “teaspoons”) for all children’s medicines and offering dosing instructions with illustrations.
ChildSafetyBlog.org applauds any move to reduce parental and caregiver confusion in this area whether it is regulation of the allowable amounts of certain medicines to be given to children, less confusing dosing language in packaging and/or pre-measurement of dosages that would make dispensing children’s medicines more accurate, effective and helpful to children. We simply wish these ground-breaking recommendations could have come sooner–for kids’, parents’ and caregivers’ sakes.