Is there an association between topical erythromycin (Erythromycin) ointment applied to the eye of a newborn and the development of hypertrophic pyloric stenosis?

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From the Guidelines

Topical erythromycin ointment for newborn eye prophylaxis is not associated with an increased risk of hypertrophic pyloric stenosis (HPS). The 0.5% erythromycin ophthalmic ointment can be safely applied to newborns' eyes to prevent ophthalmia neonatorum. The standard procedure involves applying a 1-2 cm ribbon of ointment to the lower conjunctival sac of each eye within 24 hours after birth. While oral erythromycin has been linked to an increased risk of HPS, especially when given in the first two weeks of life, topical ocular application has minimal systemic absorption, as noted in the study by 1. The concern stems from the fact that oral erythromycin acts as a motilin receptor agonist, which can increase pyloric muscle contraction and potentially lead to pyloric stenosis. However, the amount of erythromycin absorbed systemically from eye ointment is negligible and insufficient to cause this effect.

Key Points

  • The USPSTF concludes that there is high certainty that the net benefits of prophylactic ocular topical medication for all newborns outweigh the harms, as stated in the study by 1.
  • Prophylactic regimens using tetracycline 1.0% or erythromycin 0.5% ophthalmic ointment are equally effective in the prevention of gonococcal ophthalmia neonatorum, as noted in the study by 1.
  • The only drug approved by the U.S. Food and Drug Administration for this indication is erythromycin 0.5% ophthalmic ointment, as stated in the study by 1.
  • Healthcare providers should reassure parents that this prophylactic treatment is safe and remains an important intervention to prevent serious eye infections in newborns caused by organisms like Neisseria gonorrhoeae and Chlamydia trachomatis.

Recommendations

  • Apply 0.5% erythromycin ophthalmic ointment to the eyes of all newborns within 24 hours after birth to prevent ophthalmia neonatorum, as recommended by 1 and 1.
  • Monitor newborns for signs and symptoms of hypertrophic pyloric stenosis, although the risk is negligible with topical ocular application, as noted in the study by 1.

From the Research

Topical Erythromycin Ointment on Eye of Newborn

  • The use of topical erythromycin ointment on the eye of newborns is a common practice for prophylaxis against gonococcal ophthalmia neonatorum (GON) and chlamydial conjunctivitis 2, 3, 4, 5.
  • However, there is limited evidence to suggest a link between the use of topical erythromycin ointment and the development of hypertrophic pyloric stenosis.
  • Studies have shown that erythromycin ointment is effective in preventing GON, but its efficacy in preventing chlamydial conjunctivitis is less clear 3, 5.
  • A study published in 2023 suggests that the use of erythromycin ointment for neonatal ocular prophylaxis is no longer necessary due to the low incidence of gonococcal and chlamydial conjunctivitis in the United States 6.

Hypertrophic Pyloric Stenosis

  • Hypertrophic pyloric stenosis is a condition that affects infants, causing the muscle around the pylorus to thicken, leading to vomiting and other symptoms.
  • The exact cause of hypertrophic pyloric stenosis is unknown, but it is thought to be related to genetic and environmental factors.
  • There is no clear evidence to suggest a link between the use of topical erythromycin ointment and the development of hypertrophic pyloric stenosis 2, 3, 4, 5, 6.

Conclusion is not allowed, the response will continue with more subheadings and bullet points if necessary.

Erythromycin Ointment and Neonatal Ocular Prophylaxis

  • Erythromycin ointment is commonly used for neonatal ocular prophylaxis, but its effectiveness in preventing chlamydial conjunctivitis is debated 3, 5.
  • A study published in 1989 found that erythromycin ointment did not significantly reduce the incidence of chlamydial conjunctivitis in newborns 5.
  • Another study published in 2023 suggests that prenatal screening and treatment of pregnant women is the most effective way to prevent ophthalmia neonatorum, rather than the use of erythromycin ointment 6.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Prophylaxis against gonococcal ophthalmia neonatorum. A prospective study.

South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1987

Research

Neonatal ocular prophylaxis in the United States: is it still necessary?

Expert review of anti-infective therapy, 2023

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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