by Kyle Deighan
Last week, FDA warned health care professionals to exercise caution when dispensing the FDA-approved eye medicine DUREZOL® (difluprednate ophthalmic emulsion) 0.05% and the unapproved prescription topical wart remover DURASAL® (salicylic acid) 26%. This comes after several reports of injuries caused when patients expecting to receive DUREZOL®, the eye medicine approved for the treatment of inflammation and pain associated with ocular surgery, were inadvertently given DURASAL®, an unapproved wart remover. One such incident resulted in a $1 million lawsuit against Walgreens, filed by a man who put the acid wart remover in his eye after ocular surgery. Although the packaging contained the explicit instructions “not for use in eyes,” the man was using the eye drops to recover from eye surgery and was likely unable to read the warning. Perhaps the most troubling aspect of this story is that reports regarding possible confusion between DUREZOL® and DURASAL® go as far back as 2009.
In its report last week, FDA cautioned that pharmacists should exercise care when filling prescriptions for the eye medicine due to the potential for confusion between the names of the two medications. Obviously, this highlights a concerning issue that can arise with drugs that do not undergo the standard FDA approval process. Generally, as part of the drug approval process, FDA screens the proprietary names of proposed drugs for similarities with other products on the market. However, DURASAL® (the wart remover), did not undergo FDA’s approval process, and was not screened to evaluate potential name confusion with other approved products prior to entering the market. As we have written about previously (such as here), thousands of unapproved drugs remain on the market (including over-the-counter (“OTC”) drugs that also do not undergo a pre-approval process but are legal if they follow FDA’s monographs) and problems such as this continue to crop up. FDA encourages health care professionals and patients to carefully examine packaging and labeling to avoid confusion.
As for DURASAL®, according to FDA, Elorac Inc., the distributor of DURASAL®, has not responded to requests from FDA to remove the product from the market or recalled the product from shelves. DURASAL® contains an active ingredient approved for wart removal but in an amount that exceeds the maximum concentration permitted for an OTC drug, which is why it is an unapproved drug. Interestingly, Elorac Inc.’s website does not list DURASAL® as one of its products, yet information about DURASAL® is still available through Elorac when the page www.durasal.com is accessed. Elorac continues to manufacture another product containing salicyclic acid in a slightly higher amount and in a different vehicle called VIRASAL®, which also does not appear to have FDA approval, based on FDA’s list of approved drugs. Both DURASAL® and VIRASAL® state on their prescribing labeling “Rx only / FOR TOPICAL USE ONLY. / NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE”, which explains in part why some pharmacists may have been confused given that both DUREZOL® and DURASAL are labeled as prescription products.