FDA orders eye-surgery solution and wound cream off the market
The products removed from the market by the FDA are non-approved opthalmic balanced salt solutions (BSS), used to irrigate the eye during cataract surgery, and skin ointments made with the ingredient papain. Reuters reports that hundreds have been injured by these unapproved medications.
The FDA has received more than 300 complaints of eye injury and vision loss related to unapproved BSS manufactured by Baxter Healthcare Inc. and Hospira, among others. Inspections found contaminants and other product defects. Alcon, Inc. and Alkorn Inc. sell approved versions of BSS which have not been criticized and will remain on the market.
The FDA acknowledges 37 complaints related to the wound cream. The drugs are faulted for causing life-threatening allergic reactions in some patients, and there is no documented evidence that the drugs are effective in treating diabetic ulcers and other infected wounds. As a result, there are no FDA-approved versions of papain-containing skin ointment. One wonders where the FDA has been while these unapproved drugs were causing hundreds of injuries.