Erythromycin (0.5%) Ophthalmic Ointment Shortage

The Food and Drug Administration (FDA) released a report of an erythromycin (0.5%) ophthalmic ointment shortage on March 5, 2019. This is a serious problem for a number of important reasons. Erythromycin (0.5%) ophthalmic ointment is the only antibiotic ointment currently recommended and the only drug cleared by the FDA for the prophylaxis of gonococcal ophthalmia neonatorum.

Other topical medications are not recommended: tetracycline ophthalmic ointment and silver nitrate are no longer available in the United States; gentamicin was associated with chemical conjunctivitis during the last erythromycin shortage; and povidone-iodine has limited data on its benefits and harms.

Most importantly, gonorrhea ocular prophylaxis of newborns is mandated by law in most states and is considered standard neonatal care.  This prophylaxis was recently reaffirmed by the USPSTFExternal.

If erythromycin ointment is not available, CDC recommends that neonates at risk for exposure to N. gonorrhoeae during delivery (especially those born to a mother at risk for gonococcal infection or with no prenatal care) be administered ceftriaxone 25–50 mg/kg IV or IM, not to exceed 125 mg in a single dose.  For more information, please see the 2015 STD Treatment Guidelines.

It is important to remember that prenatal screening is the best method for preventing gonococcal ophthalmia neonatorum among newborns!  All pregnant women < 25 years of age and women > 25 at increased risk should be screened for N. gonorrhoeae at the first prenatal care visit and again at the third trimester if risk continues during pregnancy.  Also, all females treated for gonorrhea should be retested 3 months following treatment.

Please notify your local health department of any challenges in procuring product.

Current information regarding the availability of erythromycin (0.5%) ophthalmic ointment is available at the FDA Drug Shortage WebsiteExternal.