FDA Halts Sale of Topical Drugs Containing Papains

WASHINGTON—The U.S. Food and Drug Administration (FDA) announced that companies marketing unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement. This announcement comes after serious adverse events were linked to the use of these products. Adverse events include hypersensitivity and allergic reactions, which can lead to hypertension and rapid heart rate. In addition, patients who are allergic to latex can also be allergic to papaya, the source of papain.

Papain is a protein-cleaving enzyme derived from papaya fruit (Carica papaya) and certain other plants. Papain is often used in topical drug products to remove dead or contaminated tissue in acute and chronic lesions, such as diabetic ulcers, pressure ulcers, varicose ulcers, and traumatic infected wounds. Such products may also combine papain with other active ingredients, such as urea, chlorophyllin copper complex, and copper sodium chlorophyllin, which are intended to promote removal of unhealthy skin tissue, control local inflammation, reduce wound odors, and rehydrate skin.

Companies marketing any unapproved topical drug products containing papain must stop manufacturing them on or before November 24, 2008. Companies or others engaged in shipping these products must stop shipping these products on or before Jan. 21, 2009. After these dates, all topical products containing papain must be FDA-approved to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved topical papain products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the companies.

These actions are part of FDA’s unapproved drugs initiative that seeks to ensure all drug products marketed in the United States are shown, through a 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.

FDA’s Compliance Policy Guide (CPG) is available here.