USPSTF Reaffirms Prophylactic for Gonococcal Eye Infections in Newborns

JANUARY 29, 2019
Cecilia Pessoa Gingerich
The US Preventive Services Task Force (USPSTF) has reaffirmed its recommendation for prophylactic ocular topical medication for all newborns for the prevention of gonococcal ophthalmia neonatorum (GON). The infection can be transferred during birth from mothers who are infected with gonorrhea (Neisseria gonorrhoeae).

The recommendation was given with “high certainty that the net benefit of topical ocular prophylaxis of all newborns to prevent gonococcal ophthalmia neonatorum is substantial.” While the infection is rare in the United States—0.4 cases per 100,000 live births per year—the consequences are serious: corneal scarring, ocular perforation, and blindness as early as 24 hours following birth.

“The Task Force continues to recommend that all newborns are given antibiotic ointment to prevent GON,” said Michael Silverstein, MD, MPH, Boston University School of Medicine, Task Force member and pediatrician, in a statement. “The medicine is safe and highly effective at preventing this serious eye infection and its devastating consequences, including blindness."

The recommended prophylactic medication is 0.5% erythromycin ophthalmic ointment. This antibiotic ointment is currently the only option approved by the US Food and Drug Administration (FDA) for the prophylaxis of gonococcal ophthalmia neonatorum.

An ideal prophylactic for this use would be “effective against GON but with low risk of antibiotic resistance, not cause chemical conjunctivitis, be inexpensive in single-dose vials, and be approved by the US Food and Drug Administration, and available in the United States,” wrote Janelle M. Guirguis-Blake, MD, and co-authors of research letter accompanying the recommendation.

Guirguis-Blake and co-authors noted that erythromycin meets most of those criteria, but that concerns remain regarding potential antibiotic resistance. Additionally, they noted that there is scarce evidence on the incidence of chemical conjunctivitis with erythromycin.

The recommendation statement also addressed antimicrobial resistance, highlighting the growth in resistance around the globe and calling for more research.

“Given increased antimicrobial resistance noted in other countries, further research is needed to find safe and effective alternatives to erythromycin,” wrote USPSTF members. Earlier this week, the British Association for Sexual Health and HIV (BASHH) issued a new guideline for the management of gonorrhea, with changes made in response to growing concern over antimicrobial resistant strains of gonorrhea.

Another area found to be in need of further research is the comparison of universal prophylaxis versus risk-based prophylaxis of newborns, based on maternal risk factors. The task force also received questions during a public comment period about “the continued need for universal prophylaxis given the relative low rate of disease.”

The recommendation noted that the Canadian Pediatric Society recommends against universal prophylaxis while the practice is no longer required in countries including Denmark, Norway, Sweden, and the United Kingdom. However, the health care systems in those countries differ widely from that in the US, and in particular, prenatal care is not universal in the US.

“While screening and treatment programs have reduced the rates of gonorrhea in pregnant women, there are large disparities in access to prenatal care in the United States,” wrote the USPSTF members. Additionally, the statement cites data indicating that gonorrhea cases in the US have increased in recent years from 105.3 cases per 100,000 population in 2013 to 171.9 cases per 100,000 in 2017.

Given their findings, the task force concluded that universal prophylactic for all newborns for the prevention of gonococcal ophthalmia neonatorum was worthwhile and maintained the “A” recommendation, the highest level of recommendation.

The recommendation statement, “Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: US Preventive Services Task Force Reaffirmation Recommendation Statement,” and accompanying research letter, “Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force,” were published in JAMA.

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