What is the safety of lansoprazole (a proton pump inhibitor) in neonates?

From the FDA Drug Label

The safety and effectiveness of lansoprazole have been established in pediatric patients one year to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis. Lansoprazole was not effective in pediatric patients with symptomatic GERD one month to less than one year of age in a multicenter, double-blind, placebo-controlled study Therefore, safety and effectiveness have not been established in patients less than one year of age.

The safety of lansoprazole in neonates is not established, as it was not found to be effective in pediatric patients with symptomatic GERD one month to less than one year of age, and there is limited information on its use in this age group 1.

From the Research

Safety of Lansoprazole in Neonates

• The safety of lansoprazole in neonates has been evaluated in several studies 2, 3, 4, 5, 6.
• A study published in 2008 found that lansoprazole was well tolerated in neonates and infants, with only mild to moderate treatment-related adverse events reported 2.
• Another study published in 2021 found that the combination of lansoprazole and metoclopramide was safe and effective in treating neonates with gastroesophageal reflux disease (GERD) resistant to conservative and monotherapy 3.
• However, a study published in 2009 found that lansoprazole was not more effective than placebo in treating infants with symptoms of GERD, and that serious adverse events, particularly lower respiratory tract infections, occurred more frequently in the lansoprazole group 4.
• The pharmacokinetics of lansoprazole in neonates and infants have been found to be age-dependent, with higher plasma exposure and lower plasma clearance in younger patients 6.

Adverse Events

• The most common adverse events reported in neonates and infants treated with lansoprazole include:
  • Mild to moderate treatment-related adverse events, such as diarrhea, vomiting, and abdominal pain 2
  • Serious adverse events, such as lower respiratory tract infections 4
• The frequency and severity of adverse events may vary depending on the dose and duration of treatment, as well as the individual patient's medical history and underlying conditions.

Dosing and Administration

• The recommended dose of lansoprazole for neonates and infants varies depending on the patient's age and weight, as well as the severity of their GERD symptoms 2, 6.
• The pharmacokinetics of lansoprazole in pediatric patients are age-dependent, and younger patients may require lower doses to achieve similar plasma exposure 6.
• Lansoprazole should be administered with caution in neonates and infants, and patients should be closely monitored for adverse events and changes in their GERD symptoms.