FDA Warns About Potential Mix-Ups With Durezol and Durasal


December 29, 2011

December 29, 2011 — The US Food and Drug Administration (FDA) is warning pharmacists about 2 drugs with similar brand names that could lead to a dispensing mistake and a seriously injured patient if they are not careful.

The 2 drugs are difluprednate ophthalmic emulsion (Durezol, Sirion Therapeutics), which is FDA-approved, and Durasal (Elorac Inc), an unapproved topical wart remover containing salicylic acid. According to an FDA announcement made on December 27, the confusion caused by the similarity between the drug names is so bad that a pharmacist accidentally gave Durasal to a patient who had had eye surgery instead of the prescribed Durezol, a topical corticosteroid , indicated for relieving postoperative inflammation and pain. The patient was seriously injured as a result.

In other mix-ups, the agency said, pharmacies caught the error before patients received the wrong medicine. Clinicians also have griped about the confusing names.

The FDA tries to prevent this problem from arising in the first place. During the approval process for a new drug, the agency compares the brand name with those already on the market. However, this safety check did not occur with Durezol and Durasal, the FDA stated, because Durasal did not undergo the FDA approval process, eliminating the opportunity for the agency to evaluate the potential for confusing names. Durasal hit the market shortly after the FDA approved Durezol.

The FDA said it has asked the distributor of Durasal to remove the product from the market, but has not received a reply.

To report adverse events related to Durezol and Durasal, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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