FDA Warns Physicians of Adverse Events Linked to Use of Gentamicin Ophthalmic Ointment

FDA and CDC officials announced this week that the agencies have received reports of adverse events associated with the use of gentamicin ophthalmic ointment (0.3%) for prophylaxis against ophthalmia neonatorum, or neonatal conjunctivitis. The product is marketed by Lake Forest, Ill.-based Akorn Inc. as Gentak.

The cases, which occurred in multiple locales and included product from several lots, have involved eyelid swelling and dermatitis that appears a few days after ointment application. Most cases have been mild and have not required additional treatment, but more severe cases have been associated with blistering of the skin. None of the cases have affected the conjunctivae, orbital contents or corneas, and all cases resolved without complication.

These adverse events are being investigated by the FDA. The probability of dermatitis occurring with the use of gentamicin ophthalmic ointment cannot be reliably estimated at this time, said health officials.

Gentamicin ophthalmic ointment is one of the alternative prophylactic therapy options the CDC deemed acceptable for use in light of a shortage of erythromycin ophthalmic ointment (0.5%) announced Aug. 31. Erythromycin ophthalmic ointment is the only product available in the United States that is FDA-approved for this indication.

The CDC said Sept. 4 that azithromycin ophthalmic solution (1%), which is marketed by Inspire Pharmaceuticals as AzaSite, is an acceptable substitute if erythromycin ophthalmic ointment is not available.

If neither azithromycin ophthalmic solution nor erythromycin ophthalmic ointment is available, the agency advised that gentamicin ophthalmic ointment (0.3%) and tobramycin ophthalmic ointment (0.3%) are acceptable alternatives. Both products are marketed under various brand names and also are available as generic products.

Ciprofloxacin ophthalmic ointment (0.3%), marketed as Ciloxan by Alcon Laboratories, also can be used if none of the above-named products is available, but CDC officials said this product is a less suitable alternative because of possible gonococcal antimicrobial resistance.

Anecdotal experience from a hospital where several cases of gentamicin-related dermatitis were described suggests that wiping excess ointment off the eyelids may mitigate the reaction, if it occurs.

Although CDC and FDA officials are urging health care professionals and hospitals to make efforts to obtain erythromycin ophthalmic ointment so that alternative preparations aren't needed, public health experts continue to regard gentamicin ophthalmic ointment as an acceptable prophylactic alternative.

Rochester, N.Y.-based Bausch & Lomb, one of two manufacturers of erythromycin ophthalmic ointment (0.5%), has informed federal health officials that it anticipates sufficient product quantities to meet full market demand will be available by the end of October.

Health care professionals should continue to report adverse events associated with use of alternative neonatal eye prophylaxis products to the FDA's MedWatch program.