Unapproved topical papain products withdrawn from market

The FDA has ordered the discontinuation of all unapproved topical papain-containing drugs due to reports of serious adverse reactions.Papain products are used for the removal of dead or contaminated tissue in acute and chronic lesions and may lead to harmful or near fatal effects including hypotension, tachycardia, and anaphylaxis. There have been no studies to support the effectiveness of these products.Topical papain products affected by this action include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox.

For more information visit www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm119646.htm.