A recent announcement from the U.S. Food and Drug Administration (FDA) ordered manufacturers of unapproved topical ointments and eye salt solutions containing the ingredient papain to stop producing and marketing these products. The agency order comes in the wake of reports of allergic reactions that produced heart palpitations and a drop in blood pressure!
According to an FDA document, papain is an enzyme extracted from papaya and other fruits. Some folks use skin ointments containing papain to remove dead or contaminated skin from diabetic ulcers and infected wounds.
The agency documents said there are no FDA-approved topical drug products containing papain. Most ointments containing papain are marketed under brand names such as Accuzyme®, Ethezyme, Gladase, Panafil and Ziox®.
Also, ophthalmic balanced salt solutions (BSS) containing papain are used to irrigate the eye during cataract operations and other eye surgeries.
The FDA is urging doctors and others who use these products to switch to approved versions of BSS made by Alcon and Akorn.
FDA guidelines order companies to stop making these unapproved products on or before November 24, 2008. They must also stop shipping the unapproved products on or before January 21, 2009.
All unapproved products containing papain must have FDA approval to be manufactured or shipped across the United States. Companies that continue to market or ship unapproved products after these dates may face immediate FDA enforcement actionincluding seizure and/or injunction against the company.