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FDA Issues Alert Regarding Durezol and Durasal Confusion Due to Similar Names
FDA has issued an alert notifying pharmacists and other health care providers of potential injury due to confusion between the FDA-approved eye medicine Durezol® (difluprednate ophthalmic emulsion) 0.05% and the unapproved prescription topical wart remover DurasalTM (salicylic acid) 26%. FDA received one report of a serious injury when a pharmacist mistakenly gave an eye surgery patient Durasal, the salicylic acid-containing wart remover, instead of the prescribed Durezol eye drops. Durezol is approved for treatment of inflammation and pain association with ocular surgery. FDA notes that several other reports have been made relating to confusion between Durezol and Durasal, while in some cases, the error was discovered prior to the medication reaching the patient. FDA has also received complaints from health care providers concerning the similarity between the names Durezol and Durasal. FDA stresses that, due to the potential for confusion between these two products, pharmacists should be vigilant when filling prescriptions for the ophthalmic solution Durezol.
In the alert, FDA explains that while the agency screens proprietary names for similarities to the names of other products currently on the market as part of the drug approval process, Durasal (salicylic acid) is an unapproved product that did not undergo FDA’s drug approval process. FDA, therefore, was not able to evaluate Durasal for potential name confusion prior to the product being marketed. Additionally, Durasal (salicylic acid) entered the market shortly after FDA approved Durezol. FDA has inquired with the distributor of Durasal, Elorac, Inc, regarding the risk to patients and the removal of the product from the marketplace, but reports that no response was received as of December 28, 2011, when the FDA alert was released.
FDA requests that health care providers and patients read package labeling carefully and report any potential for confusion due to similar drugs names to the FDA MedWatch Safety Information and Adverse Event Reporting program. And, FDA notes that any side effects related to the use of Durezol or Durasal should be especially noted and reported. Reports to FDA Med-Watch can be made using the online form or by following the instructions on the Web site to submit a report by mail or fax.
