Published January 13, 2015
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 Laboratories and Akorn, Inc. have versions that are officially 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, Baxter, and Hospira, she said.
The skin cream contains an enzyme called papain, derived from the tropical papaya plant. It is used for treating skin ulcers from diabetes and other causes. Although such products have been used for more than 100 years, the FDA said there are no approved versions on the market. About a dozen companies market such creams in a lucrative business worth about $50 million a year.
The agency said it has 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 pre-date federal regulation, are a continuing problem for the FDA. The agency estimates that about 2 percent of all prescriptions written each year are for unapproved drugs, or about 72 million scripts.