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During the summer, many hospitals were faced with an erythromycin eye ointment shortage. When trying to find a replacement product, many were surprised to find that there are no other FDA-approved drug therapy options for ophthalmia neonatorum prophylaxis. Th is poses a challenge for clinicians who must choose a safe, effi cacious alternative for a practice that has been around for decades.
Dr. Carl Siegmund Franz Credé, the German gynecologist and obstetrician, first introduced prophylaxis for ophthalmia neonatorum in 1881, by cleansing the infant's eyes and instilling silver nitrate solution 2% in the conjunctival sac aft er birth. Th is therapy has since been proven eff ective in preventing opthalmia neonatorum, conjuncitivitis in the newborn, the most common gonococcal infection in neonates. Fewer data are available regarding efficacy of this approach for prophylaxis against Chlamydia trachomatis.
Silver nitrate has since fallen out of favor due to its adverse eff ects of chemical conjunctivitis and argyria, a bluish discoloration of the eyes and surrounding skin. Topical preparations can be used for ophthalmia neonatorum prophylaxis, but treatment requires systemic antibiotics. Clinical symptoms of gonococcal ophthalmia neonatorum are usually mild but can quickly progress to corneal scarring and, in severe cases, subsequent blindness.
Th erefore, prophylaxis has been identified as the preferred method to address this infection. Although rare, the devastating consequences in the small number of infected children warrant a comprehensive prophylactic approach. In the United States today, the only available FDA-approved medication for ophthalmia neonatorum prophylaxis is erythromycin ophthalmic ointment 0.5%. Th e CDC's 2006 Sexually Transmitted Disease (STD) Treatment Guidelines recommend instilling the ointment into both eyes of every neonate immediately aft er delivery. Th is guidance has subsequently been adopted as mandate in many states.
CDC addresses shortage
In late August, the CDC's Division of STD Prevention issued a statement in conjunction with the FDA regarding the shortage of erythromycin ophthalmic ointment 0.5% due to a...