The FDA came down on a group of companies that it says is marketing prescription medications without approval.
The medications are topical skin creams and eyewashes.
One is a skin cream containing a unique enzyme, called papain, derived from papaya plants, which have been in use for over a century. FDA, however, says it has never approved the use of these creams, which at least 10 companies market for the treatment of skin ulcers and other skin ailments.
As for the eyewashes, Alcon Laboratories and Akorn, Inc. have balanced salt solutions that the FDA has approved for use during surgical procedures, but none of the other three companies (Braun, Baxter and Hospira) marketing the eyewashes are approved.
The FDA has given the companies exactly two months to file for FDA approval or stop making the products. If they do not comply, the FDA can take legal action or initiate product seizures.
Customer complaints are likely the impetus behind the move: The FDA said it received hundreds of reports of serious eye reactions in people using the eyewash and close to 40 reports of everything from no benefit to severe allergic reactions from people using the papain-containing skin creams.
- get the FDA release
- read the Associated Press story