The agency is telling companies that marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drugs containing papain to stop manufacturing and marketing - or they risk enforcement action, such as seizure or an injunction - due to reports of serious adverse events. The manufacturing deadline is November 24 and the shipping deadline is January 21.

“These unapproved products have put consumers health in jeopardy, from reports of permanent vision loss with unapproved balanced salt solutions to a serious drop in blood pressure and increased heart rate from the topical papain products,” Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, says in a statement.

Ophthalmic balanced salt solutions are used to irrigate the eye during eye surgery, including cataract and other ocular procedures. The FDA has received reports of injuries including eye inflammation, cloudy vision, and permanent loss of visual acuity. Inspections found contaminants and other product defects, so the FDA is urging docs to switch to approved versions made by Alcon and Akorn.

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. Other products are marketed under the names of the active ingredients, for instance, papain-urea ointment.

The FDA received reports of serious adverse events in patients using products containing papain. Reports include hypersensitivity reactions that lead to low blood pressure and rapid heart rate. And patients who are allergic to latex can also be allergic to papaya, the source of papain.