FDA Warns Companies Selling Unapproved Ophthalmic BSS

The Food and Drug Administration has ordered companies to stop manufacturing and marketing unapproved ophthalmic balanced salt solution and topical creams containing papain, citing "reports of serious adverse events associated with their uses."

In a release, the FDA instructs companies to stop manufacturing unapproved ophthalmic balanced salt solutions by Nov. 24, 2008, and to stop shipping such products by Jan. 21, 2009, or risk federal enforcement action. The agency says it's "received reports of serious injuries to the eye from unapproved ophthalmic BSS," including "eye inflammation, cloudy vision and permanent loss of visual acuity."

Deborah M. Autor, director of the FDA's drug compliance office, told reporters that about 3.2 million units of balanced salt solution were sold last year, 1 percent of which were unapproved. Baxter International, Hospira and B. Braun Medical have sold unapproved versions of ophthalmic BSS, and spokesmen from all three companies told Bloomberg News they will stop selling them or have already done so. Alcon and Akorn both make approved versions of the drug, which are not affected by the FDA warning.

The FDA has also ordered companies to stop selling topical ointments used to treat wounds and ulcers that contain papain, an unapproved enzyme derived from papayas, which has been linked to allergic reactions and other adverse effects. "Removing unapproved topical drug products containing papain and unapproved ophthalmic balanced salt solutions is yet another step forward for patient safety," says Ms. Autor.

—Irene Tsikitas