On September 23, 2008, the FDA warned companies to stop marketing topical drug products containing papain by November 4, 2008. The FDA said, "Papain-containing drug products in topical form historically have been marketed without approval...".[11] According to the FDA's statement on the subject, "These unapproved products have put consumers' health in jeopardy, from reports of permanent vision loss with unapproved balanced salt solutions to a serious drop in blood pressure and increased heart rate from the topical papain products," said Janet Woodcock, M.D., director for the Center for Drug Evaluation and Research.
The FDA is taking action today 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). In 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.
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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. 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.
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