Study Traces Pantoprazole in Breast Milk; Raises Concern for Infant Usage
In a recent study examining the presence of pantoprazole in breast milk, minimal traces of the drug were found, and only 2 and 4 hours post-administration. The study involved a 42-year-old woman, and after 6 hours post-administration, no traces of the drug were detected. It was concluded that the relative infant dose was minimal, thus raising questions about the impact of the drug on infants.
Pantoprazole Sodium for Pediatric Patients
Pantoprazole sodium is approved for short-term treatment of erosive esophagitis (EE), a condition associated with Gastroesophageal Reflux Disease (GERD). This is applicable to pediatric patients aged between 1 and 16 years. The approval is based on extrapolated adult data and specific pediatric studies. However, the effectiveness of pantoprazole sodium for treating EE in patients under 1 year old has not been established.
Lack of Appropriate Dosage Form for Young Children
There is no appropriate dosage form for children under 5 years old. This presents a challenge in the administration of the drug to this age group. Furthermore, clinical trials have concluded that pantoprazole sodium was not effective for symptomatic GERD in infants less than 1 year old. The trials also raised concerns about the drug’s systemic exposure and its effects on gastric pH without significant esophageal pH changes.
Potential Adverse Effects on Bone Development
Animal studies have indicated potential adverse effects of pantoprazole sodium on bone development. The toxicities observed in these studies were similar to those observed in adults. As a result of these findings, pantoprazole sodium is not indicated for symptomatic GERD in infants under 1 year old. In addition, the safety of the drug in long-term use or for conditions other than EE in pediatric patients has not been established. This leaves a significant gap in our understanding of the drug’s safety profile in pediatric patients.