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The AAP is providing guidance to protect newborn babies from a serious eye infection while there is a shortage of erythromycin 0.5% ophthalmic ointment.
The ointment is the only recommended regimen to prevent ophthalmia neonatorum caused by Neisseria gonorrhoeae. The infection usually is transmitted during passage through the birth canal and can lead to blindness.
If erythromycin ointment is not available, a birthing parent who is at risk of exposure to N. gonorrhoeae or who had no prenatal care should be tested for the bacteria in the immediate peripartum setting using a nucleic acid amplification test. If the test is positive or if results are pending at the time of discharge with concerns for lack of follow-up, the infant should receive ceftriaxone. The dose is 25 to 50 milligrams (mg) per kilogram of body weight not to exceed 250 mg in a single dose. It can be given via intravenous or intramuscular administration. If ceftriaxone is unavailable or contraindicated, a single dose of ceftazidime or cefepime may be substituted.
The Centers for Disease Control and Prevention (CDC) has stressed the importance of prenatal screening to prevent gonococcal ophthalmia neonatorum among newborns. It recommends all pregnant women under 25 years and those 25 years and older at increased risk be screened for N. gonorrhoeae during their first prenatal care visit and again in the third trimester if the risk continues. Females treated for gonorrhea should be retested three months after treatment.
The Food and Drug Administration (FDA) reported a shortage of erythromycin ophthalmic ointment in July 2022. Since October 2023, the FDA has allowed the temporary importation of a product that is approved and marketed in Canada. Clinicians should notify their local health department if they have difficulty accessing erythromycin ointment.
Resources
- AAP guidance during the erythromycin ointment shortage
- AAP clinical report Risks of Infectious Diseases in Newborns Exposed to Alternative Perinatal Practices
- AAP Red Book chapter on gonococcal infections
- Information from the CDC on the shortage of erythromycin ointment
- Information from the FDA on the shortage of erythromycin ointment
- CDC sexually transmitted infections screening recommendations
- Information from the CDC on gonococcal infections in neonates
