Antidepressant recalled due to presence of potentially cancer-causing impurity
Thousands of vials of the antidepressant duloxetine have been recalled because they contain potentially cancer-causing impurities above federal safety limits. a notification From the US Food and Drug Administration.
Duloxetine is a prescription medication used to treat depression and anxiety. The affected pills were voluntarily recalled by the manufacturer, Towa Pharmaceutical, and Breckenridge Pharmaceutical Inc. Distributed by.
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The recall was issued due to the presence of N-nitroso-duloxetine, an impurity found in the drug at levels exceeding the FDA’s recommended limit.
according to fdaExposure to nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and for long periods of time.”
The agency notes that people exposed to these impurities at or below the acceptable daily intake limit are not expected to have an increased risk of cancer.
Anastasiia Voloshko/Getty Images – stock photo of person holding tablet and medicine bottle, representing personal health, treatment and responsible medication use at home
While there is no specific evidence directly linking n-nitroso-duloxetine to cancer, it belongs to a class of compounds known as nitrosamines, some of which are considered possible human carcinogens.
The health risks associated with these substances generally depend on the amount and duration of exposure; Higher levels over longer periods of time are a greater concern.
FDA classified the action as a Class II recall; This means that use or exposure to the product “is likely to cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote.”
ABC News reached out to the company for comment but did not immediately hear back.
