Unapproved Drugs Causing Vision Loss and Blood Pressure Problems

The FDA Cracks Down on Unapproved Eye Wash and Skin Cream

The FDA announced today that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action.

The FDA has received reports from consumers who have developed permanent vision loss resulting from the use of unapproved balanced salt solutions. The agency has also received reports of life-threatening drops in blood pressure and increased heart rates from products containing topical papain.

Ophthalmic balanced salt solutions are used to irrigate the eye during eye surgery, including cataract and other ocular procedures. The FDA is urging doctors and others who use these products to switch to approved versions of BSS made by Alcon and Akorn.

Topical drug ointments containing papain are used to remove dead or contaminated tissue in 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. Other products are marketed under the names of the active ingredients, for instance, papain-urea ointment.

SEPT-23-08: FDA Cracks Down on Unapproved Drug Products [FDA: UNAPPROVED DRUGS]

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Published on Sep-23-08