FDA Cracks Down on Unapproved Eye Washes, Skin Creams

Companies that sell eye washes and skin creams that have not been evaluated or approved by the Food and Drug Administration must either file for FDA approvals or stop selling the products within 60 days, federal officials said.

The eye wash, known as a balanced-salt solution, is designed to keep eyes moist during surgical procedures. While Alcon Laboratories and Akorn, Inc., currently manufacture and sell FDA-approved eye washes, three companies — B. Braun, Baxter, and Hospira – market unapproved eye washes. Only the unapproved products are being targeted by federal officials.

The skin creams in question contain papain, an enzyme derived from the papaya plant, which has been used for over 100 years to treat skin ulcers caused by diabetes and other conditions. Although about a dozen products containing papain bring in an estimated $50 million in sales annually, the FDA cautioned that none of the products are approved.

The FDA has received more than 300 reports of serious reactions to unapproved eye washes, officials said. About 40 reports of life-threatening allergic reactions and other complications from the unapproved papain skin creams have also been received.

About two percent of all prescriptions written in the United States each year – about 72 million scripts — are for unapproved drugs such as those now being targeted, according to the FDA.

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