September 24, 2008
FDA Cracks Down On Cream And Eye Wash
Federal officials started a crackdown against several companies that market an eye wash and popular skin cream without government approval.
The eye wash is used to keep the eyes moist during surgery.
The FDA said in a public notice, that two companies, Alcon Laboratories and Akorn, Inc. have versions that are officially approved by the Food and Drug Administration, and are not affected.
However, three other firms are selling similar types of eye wash without federal validation of their safety and effectiveness, according to Deborah Autor, who directs the FDA's unapproved drugs initiative.
Autor said they are B. Braun, Baxter, and Hospira.
The skin cream contains an enzyme called papain; it's used for treating skin ulcers from diabetes and other causes.
Such products have been used for more than 100 years and the FDA said there are no approved versions on the market. Twelve companies market such creams in a lucrative business worth about $50 million a year.
The FDA has received more than 300 reports of dangerous 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.
Violators face FDA seizures and other legal action. Unapproved drugs are a growing problem for the FDA.
The agency says about 2 percent of all prescriptions written each year are for unapproved drugs, or about 72 million scripts.
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