The US Food and Drug Administration (FDA) has ordered companies to stop marketing unapproved drug products that contain papain for topical application to the skin.

Papain is an enzyme derived from papaya fruit (Carica papaya) and certain other plants used to remove dead or contaminated tissue from diabetic ulcers, pressure ulcers, varicose ulcers, and traumatic infected wounds.

The products in question combine papain with other ingredients such as urea, chlorophyllin copper complex, and copper sodium chlorophyllin, which are promoted for removal of unhealthy skin tissue, control of local inflammation, reduce wound odors, and to rehydrate skin.

There are several reasons supporting the FDA’s decision.

• Absence of scientific studies supporting its use.
• Complaints that the products are ineffective
• Safety issues
• 37 reports of adverse reactions to topical papain products
• Anaphylaxis and anaphylactic shock within 15 minutes of topical papain use hospitalization
• Published reports of hypersensitivity to other papain-containing products, including meat tenderizer, contact lens solution, and adhesive removers in the beauty industry
• Cross-reactivity between latex and papaya, including a report to the FDA of anaphylactic shock in a patient with a history of allergy to latex
• Lack of sufficient warning to consumers about these risks

Approximately 35 products are involved, including the following.

• Accuzyme
• Allanfil
• Allanzyme
• Ethezyme
• Gladase
• Kovia
• Panafil
• Pap Urea
• Ziox

Regranex gel for diabetic foot ulcers, and Santyl ointment to treat chronic dermal ulcers and severely burned areas are alternative options.

9/26/08 17:30 JR