The U.S. Food and Drug Administration (FDA) issued an alert to pharmacists nationwide on December 28, 2011 regarding two drugs with similar-sounding names but very different uses, warning them of the risk of serious injury if one drug is accidentally substituted for the other. Durezol is an FDA-approved eye medicine that consists of a 0.05% solution of ophthalmic chemicals. Durasal, meanwhile, is a topical wart remover. It is not formally approved by the FDA, and it consists of a 26% solution of salicylic acid. Both drugs are available with a doctor’s prescription.
Ordinarily the FDA would screen trade names to see if they were substantially similar to an existing name in a way that might confuse consumers, but it never subjected Durasal to is formal approval process. Durasal reportedly went on the market shortly after the FDA approved Durezol.
Complaints about confusion between the two drugs began as early as 2009, with ophthalmic patients accidentally receiving the wart remover Durasal. Obviously a solution of more than a quarter acid is not ideal to place into one’s eye, and several patients have allegedly suffered severe eye injuries as a result. Durasal’s manufacturer, Elorac, Inc., has reportedly not responded to the FDA’s request to discuss a possible recall of the drug. The Philadelphia Inquirer reported that a company spokesperson at one time said the company planned to introduce a new product, also containing salicylic acid but with a different name. As of early January 2012, however, Durasal remains on the market.
A New York City patient filed a lawsuit against pharmacy chain Walgreens in early 2011 for mixing up the two medications. The man had just undergone minor eye surgery and went to fill a prescription for Durezol, the eye medicine. The pharmacy allegedly gave him Durasal instead, causing what he described as “grievous personal injury.”
The Consumerist reports that, despite packaging and warning labels, medicine mix-ups are a fairly common occurrence. They reference the story of an Arizona woman who mistook superglue for eyedrops in 2010 and needed emergency medical intervention. Eye drops may present a particular problem, since some patients may not able to immediately review the label and instructions due to impaired vision. The packaging for Durasal includes a clear warning that the product is “NOT FOR USE IN EYES,” but media reports do not indicate if pharmacies ordinarily dispense the medication in its original packaging, or if the warning was visible to the particular injured individuals.
Pharmacists have special training and certification, and so the law imposes a higher degree of responsibility on them when they make a mistake in their professional duties that causes injury, such as dispensing the wrong drug to a patient. A patient must meet a legal test to prove negligence, showing that a pharmacy breached its duty of care to the patients and directly caused actual damage. If the patient can do this, the patient may recover their medical costs, compensation for pain and suffering, lost wages caused by their injuries, and other damages.
The Maryland pharmacy error attorneys at Lebowitz & Mzhen can assist you if you have been injured by drugs prescribed or administered incorrectly. Contact us today online or at (800) 654-1949 to see if you may recover damages.
More Blog Posts:
FDA Wants More Warning Label Information for Yaz, Pharmacy Error Injury Lawyer, December 27, 2011
Preventing Medication Mix-Ups at the Pharmacy, Pharmacy Error Injury Lawyer, October 5, 2011
Risperdal Recalled by Manufacturer Due to Drug Contamination, Pharmacy Error Injury Lawyer, July 29, 2011
Photo credit: Eye on you by qute on stock.xchng.