Depressed people may have another reason to feel down. Towa Pharmaceutical Europe voluntarily initiated a recall of its antidepressant drug, Duloxetine, according to the U.S. Food and Drug Administration.
The recall, which affects the drug’s delayed-release capsules, came after Duloxetine was found to contain more than the acceptable limit of N-nitroso-duloxetine. Per the National Library of Medicine, the chemical is suspected of causing cancer and toxic if swallowed.
“There are multiple reasons why nitrosamines can be present in drugs. FDA found the source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged,” the FDA told Newsweek in a statement. “As foods and drugs are processed in the body, nitrosamines can also be formed. FDA continues to test and research possible sources for drugs found to contain nitrosamines.”
The recall was given the second highest classification by the FDA. That means that exposure to the drug may cause temporary or medically reversible adverse health consequences, but that the probability of serious adverse health consequences is remote.
What Duloxetine Users Should Do in the Wake of the Recall
Per Mayo Clinic, Duloxetine, which is known by brand names Cymbalta, Drizalma Sprinkle, and Irenka, is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes. Duloxetine can additionally be used to treat fibromyalgia and long-lasting pain that is related to muscles and bones.
The recall impacts more than 7,100 bottles of the drug, which works by increasing the activity of serotonin and norepinephrine in the brain.
“Patients taking prescription medications with potential nitrosamine impurities should not stop taking their medications. Patients should talk to their health care professionals about concerns and other treatment options,” the FDA told the outlet. “The agency is working to determine the source of these impurities and will keep the public informed.”
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