FDA targets producers of eye wash, skin cream

Federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks.

The eye wash, known as a balanced salt solution, is used to keep the eyes moist during surgery. Two companies, Alcon Inc. and Akorn Inc. have versions that are approved by the Food and Drug Administration, and are not affected, the FDA said in a public notice.

But three other firms are selling similar types of eye wash without federal validation of their safety and effectiveness, said Deborah Autor, who directs the FDA’s unapproved drugs initiative. They are B. Braun Medical Inc., Baxter International Inc. and Hospira Inc., she said.

The skin cream contains an enzyme called papain, derived from the tropical papaya plant. It is used for treating skin ulcers resulting from diabetes and other causes. Although such products have been used for more than 100 years, the FDA said there were no approved versions on the market. About a dozen companies market such creams in a business worth about $50 million a year.

The agency said it had received more than 300 reports of serious reactions to the eye wash, and about 40 reports on the papaya creams, including some that said the ointment was of no help to patients and others describing life-threatening allergic reactions.

Companies making the unapproved products must file for FDA approval or cease production by Nov. 24. Violators face FDA seizures and other legal action.

Unapproved drugs, many of which predate federal regulation, are a continuing problem for the FDA. The agency estimates that about 2% of all prescriptions written each year are for unapproved drugs, or about 72 million scripts.