Unapproved BSS and Papain Products

On September 23, 2008, as part of what the FDA is calling its “unapproved drug initiative,” the FDA ordered manufacturers of two different unapproved drug product types to stop manufacturing and shipping the products.

First, the FDA’s warning affects unapproved Balanced Salt Solution (BSS) products, which are ophthalmic solutions used during eye surgery to help irrigate the eye. The FDA clarified that approved BSS products are unaffected by the FDA’s warning and that, in the future, the FDA will require approval of any BSS solution in order to market and sell it. Unapproved BSS products have been reported to the FDA as causing eye inflammation, cloudy vision, and permanent loss of visual acuity. The FDA is urging physicians who might be using unapproved BSS products to switch to approved brands.

Second, the FDA’s warning affects topical products containing papain, which is an enzyme found in papaya. Topical ointments containing papain are typically used for the removal of dead or contaminated tissue in lesions, ulcers, and wounds. There are currently no topical drug ointments containing papain that are FDA approved.

Manufacturers of both categories of unapproved products are required to stop manufacturing the products by November 24, 2008 and stop shipping the products by January 21, 2009. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01890.html

If you reason to believe that you have been treated with either an unapproved BSS or an unapproved topical ointment containing papain, and you were injured as a result, please feel free to contact our law firm for a free consultation at http://www.pbmattorneys.com.