FDA Cites Dosing Errors In New Recommendations For Children's OTC Medications
Underscoring the importance of weight-based dosing for over-the-counter (OTC) children's medications, the Food and Drug Administration (FDA) recently announced its recommendation that cold and cough medications be relabeled: "For Children Ages 4 and Up."
Emphasizing that dosing errors and accidental ingestions are the leading causes of adverse events in children related to cough and cold ingredients, OTC manufacturers voluntarily agreed to change the dosing directions, according to the Consumer Healthcare Production Association (CHPA).
Dosing by age rather than weight is a core issue of the safety and efficacy of cough/cold products for children. Many pharmaceutical manufacturers state on their labels or Web sites, "If possible, dose by weight," but actually provide directions in wide age groups because there is not enough room to provide dosing directions by specific weight. For example, the instructions for a popular cough medication has children in the 2 to 6 age group with weights ranging from 24 lbs. to 48 lbs., all receiving the same dose of medication. By weight-based dosing standards, only children weighing between 24 lbs. and 28 lbs. would achieve effective results. The remainder would be under-dosed by 17%-50%.
"It has been my experience that when dosed correctly, over-the-counter medications work properly. But, when we under-dose, symptoms return before the next scheduled dosing," said Brian Kaplan, M.D., a pediatrician and 20-year emergency room physician who is used to seeing the result of inaccurate dosing. "I recommend weight-based dosing to all my patients and applaud the direction the industry is taking. I'm pleased to see more health care professionals and caregivers focusing on the real problem - proper dosing."
To meet the need for safe and effective dosing, Dr. Kaplan spent seven years creating AccuDial, a patented, rotating labeling system that enables precise dosing of children's medications by weight.
About AccuDial, Inc.
AccuDial, Inc. has filed with Health Canada for approval to launch a family of nine over-the-counter analgesic, allergy, cold, and cough medications by mid-2009. The company is working on obtaining Food and Drug Administration approvals in the United States, as well as international regulatory agencies for European distribution. The company's patented dosing solution enables a caregiver to rotate the bottle's label and quickly find the correct dose based on a child's specific weight. Every AccuDial product includes a dosing spoon that is calibrated to match the dosing directions.
SOURCE: AccuDial, Inc.