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FDA issues alert about confusion between similarly named drugs
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The U.S. Food and Drug Administration has issued a warning to pharmacists and health care providers about potential injury stemming from confusion between an ophthalmic solution and a prescription topical wart remover with similar names.
The warning stemmed from a report of serious injury when a pharmacist erroneously gave an eye surgery patient Durasal (salicylic acid 26%, Elorac) rather than Durezol (difluprednate ophthalmic emulsion 0.05%, Alcon), which is approved by the FDA for inflammation and pain associated with ocular surgery .
Other cases of name confusion have been reported, according to an FDA news release.
"Due to the potential for confusion between these two products, pharmacists should be vigilant when filling prescriptions for the ophthalmic solution Durezol," the release said.
Durasal did not undergo the FDA's drug approval process and entered the market shortly after Durezol was approved, according to the release. The FDA was unable to evaluate Durasal for potential name confusion before the product was marketed.
Elorac has not responded to an FDA inquiry into removing Durasal from the market and has not recalled the product in the wake of the FDA inquiry into patient risk, the release said.
Health care professionals and patients may report potential confusion over similar drug names to the FDA's MedWatch Safety Information and Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm. Reporting forms may also be requested by calling 1-800-332-1088.