FDA requires that companies stop manufacturing products containing topical papain.
Historically, topical papain products were allowed to be marketed without FDA approval. However, in June 2006, the FDA ruled that pre-1962 drugs required approval and that those without approval would be removed in a risk-based approach. On September 23, 2008 the FDA announced that companies marketing topical drug products containing papain must stop manufacturing the products on or before Nov 23, 2008 and cannot be shipped in interstate commerce after January 21, 2009. This includes approximately 35 topical products used to treat wounds.
Rationale: From 1969 to January 2008 the FDA cites 37 reports of serious adverse events associated with use of topical papain products. These include anaphylactic shock and hypersensitivity to products containing papain, including meat tenderizer, contact lens solutions and adhesive removers. There is also cross reactivity between latex and papaya, creating a risk for patients with latex sensitivity. The FDA notes a lack of well controlled studies demonstrating efficacy of the products and therefore cannot assess whether the benefits outweigh the documented risks.
More information on the FDA’s decision can be found at www.fda.gov/CDER/news/papain/qa.htm
Given that the WHS Guidelines recommend debridement as a critical aspect of wound bed preparation, the practitioner now has fewer options for chemical debridement. Currently the only FDA-approved enzyme for debridement is collagenase, derived from fermentation of Clostridium histolyticum. However, other choices including sharp, mechanical, autolytic and biological debridement remain and will likely see increased utilization. Additional scientific studies will clarify the relative efficacy of these choices for different types of wounds (and is the only way to ensure continued FDA and insurance company approval). Documentation of the medical necessity for debridement and the type of debridement will facilitate appropriate reimbursement.
Submitted by Lisa Gould, MD, PhD
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