Erythromycin Ophthalmic Ointment in Short Supply

The CDC is informing physicians of a shortage of erythromycin (0.5%) ophthalmic ointment, which is the only product available in the United States that is recommended for prophylaxis against ophthalmia neonatorum, or neonatal conjunctivitis.

The AAFP (scroll down to "Gonococcal Infection in Neonates") "strongly recommends prophylactic ocular topical medication for all newborns" to prevent gonococcal ophthalmia neonatorum. The American Academy of Pediatrics and the U.S. Preventive Services Task Force, or USPSTF, also recommend this prophylaxis, which is required by law in most states.

The USPSTF said in its recommendations for gonorrhea screening that there is good evidence that blindness due to gonococcal ophthalmia neonatorum has become rare in the United States since the implementation of universal preventive medication of newborns.

The use of erythromycin ophthalmic ointment also protects infants from ocular infection caused by Chlamydia trachomatis.

The CDC noted in its Aug. 31 letter to physicians (1-page PDF; About PDFs) that tetracycline ophthalmic ointment (1%) and silver nitrate (1%) aqueous solution -- which also were recommended for prophylaxis against ophthalmia neonatorum in STD treatment guidelines the CDC issued in 2002 -- now are no longer available in the United States.

Those STD treatment guidelines were updated in 2006, but tetracycline ophthalmic ointment was still listed, along with erythromycin ophthalmic ointment, at the time of publication of that guidance.

According to the letter, CDC officials are consulting with experts "to provide alternate recommendations for extreme situations where erythromycin ophthalmic ointment is not available," and recommendations are forthcoming.

According to information on the FDA Web site, the shortage was caused by a change in manufacturers, and the agency is working with drug makers to increase the supply of erythromycin (0.5%) ophthalmic ointment.

The FDA notes that Fera Pharmaceuticals recently acquired the rights to the product and is working to make the ointment available. Bausch & Lomb also manufactures the product and is working to increase production.

FDA officials add that although erythromycin ophthalmic ointment also is approved for the treatment of superficial conjunctival or corneal infections caused by organisms susceptible to erythromycin, physicians are asked to consider alternative drugs for this indication during the shortage to maximize availability of the product for ophthalmia neonatorum prophylaxis.

The CDC letter urges physicians to take the following steps:

"The 2006 STD Treatment Guidelines outline recommended prophylactic treatment for infants whose mothers have gonococcal infection and for management of infants born to mothers who have untreated Chlamydia," the letter notes.