The original New Drug Application (NDA) for the approval of Children’s and Infants Ibuprofen recite safety and efficacy studies in fixed dosing of mg to kg. In fact, the majority of all clinical and pivotal safety studies in support of the approval of pediatric ibuprofen,1 such as the Boston Fever Study,2 were conducted and published also in fixed dosing, in either 5mg/kg or 10mg/kg. Moreover, the Food and Drug Administration’s Medical Reviewer’s final comments for pediatric approval, concluded the safety of OTC Ibuprofen in pediatric populations at the two doses tested, 5mg and 10mg.3
Collectively, the clinical data supported the approval of the NDA for Pediatric OTC Ibuprofen and the NDA continues to recite a fixed dose of either 5mg or 10mg/kg; depending on the patient’s baseline temperature or other condition.4 The American Association of Pediatrics also recommends a fixed dose of 10mg/kg,5 as well as other worldwide health agencies recommend a fixed dose to pediatric patient weight.
Contrary to all of the collective data, the current U.S. mL dosing regimen for Ibuprofen provides a highly variable dosing to these subtle pediatric patients. For example, current mL dosing provides the lowest weight and youngest patients (12lb at 6 months), the near maximum dose of 4.17mg/lb (9.2mg/kg) and the heaviest weight and oldest patient within that same range the lowest dose of 2.94mg/lb (6.48mg/kg). Additionally, the current regimen also provides extreme dosing variations, such as offering a 17lb patient 2.9mg/lb and an 18lb patient 4.2mg/lb, a percentage change of over 44% despite a one-pound difference in weight.