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Tuesday, 07 September 2010

FDA to Restrict all Topical Drug Products Containing Papain

On September 23, 2008 The FDA warned companies to stop marketing topical drug products containing papain by November 4, 2008. The FDA stated, “No topical drug product containing papain has been approved by the FDA.” According to Janet Woodcock M.D., director of drug evaluation and research, “These unapproved products have put consumers health in jeopardy, from reports of permanent vision loss with unapproved ophthalmic balanced salt solutions to a serious drop in blood pressure and increased heart rate from topical papain products.”

About Papain Products

Topical drug ointments containing papain are used to remove dead or contaminated tissue in acute and chronic lesions, such as diabetic ulcers, pressure ulcers, varicose ulcers, and traumatic infected wounds. Trade names for these products include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox. Papain is also used in meat tenderizers, toothpaste or mints and is used a a tooth whitener.

If you are using one othe above mentioned products be aware that serious side effects including hypersensativity (allergic) reactions, that lead to hypotension (low blood pressure) and tachycardia (rapid heart beat) have been reported. 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.

If you are using a papain containing product contact your physician to get a replacement drug.

-drhinkes

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Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.