Update on Erythromycin (0.5%) Ophthalmic Ointment Shortage

Alabama Department of Public Health (ADPH)
Alabama Emergency Response Technology (ALERT)
Health Alert Network (HAN)
January 30, 2024

Erythromycin (0.5%) ophthalmic ointment shortage

In July 2022, the U.S. Food and Drug Administration (FDA) reported a shortage of erythromycin (0.5%) ophthalmic ointment.  This shortage is ongoing and has affected patient care in Alabama.  Erythromycin (0.5%) ophthalmic ointment is used as prophylaxis and is currently the only recommended regimen to prevent ophthalmia neonatorum caused by N. gonorrhoeae.  This 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 for exposure to N. gonorrhoeae or who had no prenatal care should be tested for N. gonorrhoeae in the immediate peripartum setting using a nucleic acid amplification test (NAAT).  Risk factors include the following:

Women < 25 years old, and those 25 years or older who have:

  • a new partner
  • more than one sex partner,
  • a sex partner with concurrent partners, or a sex partner who has a sexually transmitted infection (STI), or live in a community with high rates of gonorrhea
  • practice inconsistent condom use when not in a mutually monogamous relationship
  • have a previous or coexisting STI
  • have a history of exchanging sex for money or drugs; or have a history of incarceration

If the birth parent’s test is positive for gonorrheal infection or if the test result is pending at time of discharge with concerns for lack of follow-up, the neonate should receive ceftriaxone, 25 to 50 mg/kg of body weight, IV or IM, not to exceed 250 mg in a single dose; 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 (see above) 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. 

Currently, short term shortages at the wholesale level are expected to continue due to both shipping delays and discontinue of the manufacture of the drug.  Since October 2023, the FDA has allowed the temporary importation of a non-FDA approved product that is approved and marketed in Canada manufactured by Fera Pharmaceuticals, LLC (Fera), in conjunction with Steri-Med Pharma, Inc.

Additional information regarding the availability of erythromycin (0.5%) ophthalmic ointment is available on the FDA Drug Shortage page.