OTC Product Confusion and Unintentional Salicylism in an Infant

Background: Maalox registered is a common over-the-counter (OTC) gastrointestinal product We present a case of salicylism in a 12-month-old from the use of a bismuth subsalicylate-containing Maalox registered product given in error. Case Report: A 12-month-old child presented to a pediatric emergency department with poor feeding, abdominal distension, irritability and decreased urinary output His past medical history is significant for pyloric stenosis, failure to thrive and developmental delays. He was afebrile, tachycardic at 180, respirations at 56 and hypertensive. Labs indicated an anion gap metabolic acidosis (pH 7.291, bicarbonate 12, anion gap 23). He was admitted to the Pediatric Intensive Care Unit (PICU). A toxicology screen revealed a salicylate level of 77 mg/dL. The poison center was consulted and recommended alkalinization, potassium replacement, dialysis and a head CT. Sodium bicarbonate was initiated. The patient developed pulmonary edema requiring intubation. The salicylate concentration decreased without dialysis to < 5 mg/dL by day 2. The child was extubated on day 3; deep vein thrombosis from line placement complicated his course but it was treated and resolved. He was transferred from the PICU on day 4 and was discharged to home on day 6 with plans to follow up with his pediatrician. Case Discussion: This case highlights the potential for significant morbidity from OTC medications and the confusion created by multiple formulations of a brand name. The child's mother reported that she was instructed to give Maalox registered but inadvertently substituted Maalox Total Stomach Relief Maximum Strength Liquid registered , containing bismuth subsalicylate, 525 mg per 15 ml. The child received 1 teaspoon four times daily, for two months. Conclusion: Health care professionals need to be specific in their recommendation of OTC products, highlighting the active ingredients. Consumers need to be educated on the importance of checking labels. Companies need to understand the risk from consumer choice of the wrong formulation due to marketing pitfalls of brand recognition and package familiarity.