FDA Cracks Down on Eye Wash and Skin Cream

September 2008

The Food and Drug Administration (FDA) has announced that it is strengthening regulation of two popular medications that do not have government approval. The products, eye wash and skin cream, have been associated with negative side effects and could pose health risks to users.

The eye wash, known as balanced salt solution, is used during surgery to keep eyes moist. The FDA has received more than 300 reports of serious eye reactions to the solution. Currently, Alcon Laboratories and Akorn, Inc. have versions that are officially approved by the FDA. Three other companies, B. Braun, Baxter, and Hospira, do not have approval for their versions.

The skin cream in question contains an enzyme called papain and is derived from the papaya plant. It is used to treat skin ulcers, and the FDA reports that there are no approved versions on the market. The agency has received 40 reports about the papaya creams, some saying that the ointment has no effect and others describing life-threatening allergic reactions.

Companies that make the unapproved medications must file for approval or stop production by November 24. The FDA estimates that every year about 72 million prescriptions are written for unapproved drugs.