[12/28/2011] FDA is alerting pharmacists and other health care professionals 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 Durasal (salicylic acid) 26%.
There has been one report of 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.
Several other cases were reported arising from confusion between Durezol and Durasal. In some cases, the error was discovered prior to the medication reaching the patient. There were also complaints received from health care practitioners concerning the similarity between the names Durezol and Durasal.
Due to the potential for confusion between these two products, pharmacists should be vigilant when filling prescriptions for the ophthalmic solution Durezol.
The FDA, as part of the drug approval process, screens proprietary names for similarities to the names of other products currently on the market; however, Durasal (salicylic acid) is an unapproved product that did not undergo FDA’s drug approval process. The agency, 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.
Elorac, Inc., the distributor of the unapproved product Durasal, has to date not responded to FDA's inquiry into removing the product from the market place. To date, Elorac has also not recalled the product in response to FDA's inquiry regarding the risk to patients.
Health care professionals and patients are encouraged to scrutinize packaging and labeling information carefully and to report any potential for confusion arising from similar drug names to the FDA’s MedWatch Safety Information and Adverse Event Reporting program. In this context, any side effects associated with the use of Durezol or Durasal should be especially noted and reported.
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The FDA remains vigilant in monitoring adverse event reports and is requesting pharmacists and other health care providers to be extra cautious in prescribing and dispensing all products.