You Say ‘Durezol,’ I Say ‘Duresal’ — FDA Warns of Drug Mix-Ups
(WASHINGTON) -- If you want the prescription eye drops called Durezol, make sure your pharmacist doesn’t hand you a bottle of the salicylic acid-containing wart remedy Duresal.
At least one patient has been seriously injured in just such a mix-up, according to a warning to pharmacists and health care professionals the U.S. Food and Drug Administration issued Wednesday. And according to the FDA, several other cases of confusion between the two drugs have been reported, likely as a consequence of the similarities between the names of the two very different drugs.
It’s far from the first time similar names have led to confusion and drug mix-ups, and it’s unlikely to be the last. After all, in the sea of drugs available to treat everything from your anemia to your zygomycosis, there are bound to be some names that resemble each other. The FDA, as part of the drug approval process, screens the names of these medications in an effort to ensure that they don’t sound too much like an existing medicine.
In this case, however, Durasal was never required to undergo the FDA’s drug approval process; subsequently, its name was never vetted. To make matters worse, Durasal entered the market shortly after the FDA had already approved Durezol.
It may also be worth noting that the packaging for Durasal, displayed on the National Institute of Health’s DailyMed site, includes the warning “NOT FOR USE IN EYES” in its design.
As of Wednesday, Elorac, Inc. -- the Vernon Hills, Ill.,-based distributor of Durasal -- had not yet responded to inquiries from the FDA regarding the removal of the product from the marketplace or its recall. A message left with Elorac on Thursday afternoon requesting comment was not immediately answered.
It’s safe to say that similar-name issues have dogged regulators for years. In 2002, the FDA issued a report detailing six cases of children who were prescribed methylphenidate, a drug to treat attention-deficit disorder, receiving methadone, a drug to treat narcotic addiction, instead.
In 2004, the FDA issued a similar report after four patients who were supposed to receive the anti-seizure pill Keppra instead received the HIV drug Kaletra.
And in 2010, manufacturers of the popular antacid medication Kapidex renamed their product at the FDA’s request, in light of its confusion with the prostate cancer drug Casodex. This name change was part of an FDA crackdown that began last year on the long list of drugs with similar-sounding names.
Past FDA efforts include the agency’s 2001 launch of the Name Differentiation Project, during which the manufacturers of 16 drugs were encouraged to add “Tall Man” lettering to labels for the syllables that differentiated one drug from another. Pretty important, if you happen to be taking MethylPREDNISolone for your allergies and your pharmacist hands you MethylTESTOSTERone, an anabolic steroid instead.
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