The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drugs containing papain must stop manufacturing these products on or before November 24, 2008, and must stop shipping such unapproved products on or before January 21, 2009, or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses, including eye inflammation, cloudy vision, permanent loss of visual acuity, a serious drop in blood pressure and increased heart rate.
Ophthalmic balanced salt solutions are used to irrigate the eye during surgery on the eye, including cataract and other ocular procedures. The FDA’s action does not affect approved ophthalmic BSS products such as approved versions of BSS made by Alcon and Akorn. No topical drug product containing papain has been approved by the FDA. After the above dates, all topical products containing papain must have FDA approval to be manufactured or shipped in interstate commerce.
Because there are FDA approved opthalmic products that can be used to irrigate the eye during surgery on the eye, including cataract and other ocular procedures, there does not seem to be any good reason to use an unapproved product containing papain.
If you or someone you know suffers from eye inflammation, cloudy vision, permanent loss of visual acuity, a serious drop in blood pressure and increased heart rate following eye surgery, investigation should be made into just what BSS was used during the procedure.
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The FDA action is also directed at unapproved topical papain products. Topical drug ointments containing papain are used to remove dead or contaminated tissue in acute and chronic lesions, such as diabetic ulcers, pressure ulcers, varicose ulcers, and traumatic infected wounds. Trade names for these products include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox. Other products are marketed under the names of the active ingredients, for instance, papain-urea ointment. The FDA took action against these products because it has received reports of serious adverse events in patients using products containing papain.
Reports include hypersensitivity (allergic) reactions that lead to hypotension (low blood pressure) and tachycardia (rapid heart rate). I n addition, patients who are allergic to latex can also be allergic to papaya, the source of papain. Therefore, patients with latex sensitivity may be at increased risk of suffering an adverse reaction to a topical papain drug product. There are a number of FDA-approved topical products that have been found safe and effective as wound healing agents and that do not contain papain.
FDA urges consumers who are using topical drug products containing papain, and who have questions or concerns, to contact their health care provider about discontinuing treatment with these products. These actions are part of FDA’s unapproved drugs initiative. That initiative seeks to ensure that all drug products marketed in the United States are shown, through the drug approval process, to be safe and effective and to meet appropriate standards for manufacturing and labeling.
This represents the eighth and ninth actions taken by the agency against a class of unapproved drugs since issuing a compliance policy guide (CPG) on marketed unapproved drugs in June 2006. The CPG describes FDA’s risk-based enforcement approach to marketed unapproved drugs.