Erythromycin Ophthalmic Ointment Supply Increasing

A nationwide shortage of erythromycin (0.5%) ophthalmic ointment appears to be nearing its end, but hospitals and other customers are being asked to limit their orders to quantities that meet their immediate needs.

The FDA said on its Web page dedicated to drug shortages that production has increased and is expected to increase again after the first quarter of 2010, allowing customers to build inventory.

When the shortage -- caused by a change in manufacturers -- was first reported earlier this year, erythromycin ophthalmic ointment was the only product available in the United States recommended for prophylaxis against ophthalmia neonatorum, or neonatal conjunctivitis.

Fera Pharmaceuticals announced in July that it had acquired the rights to seven prescription products -- including erythromycin ophthalmic ointment -- that account for more than 80 percent of ophthalmic ointment volume on the U.S. market.

The company said at that time that it planned to distribute limited amounts of the products while initiating technical transfers and obtaining regulatory approvals. The company has said that it anticipates Fera-labeled products will be available early in 2010.

The FDA said Bausch & Lomb, which also manufactures erythromycin ophthalmic ointment, has alleviated the shortage by increasing its production.

The AAFP "strongly recommends prophylactic ocular topical medication for all newborns" (scroll down to "Gonococcal Infection in Neonates") 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 updated its recommendations to physicians for prophylaxis against ophthalmia neonatorum, or neonatal conjunctivitis, earlier this year in response to the shortage, including advice on alternative products. One of those products, gentamicin ophthalmic ointment (0.3%), was later linked to adverse events.