The U.S. Food and Drug Administration (FDA) has been forced to recall thousands of bottles of the antidepressant medication Duloxetine, the generic version of Cymbalta, due to potentially cancer-causing chemicals above the acceptable limit.
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According to the federal agency’s Oct. 11 enforcement report, over 7,100 bottles of Duloxetine were recalled. This also includes 500 delayed-release 20mg capsules. The lot number is 220128, with the expiration date 12/2024. The chemical found is nitrosamine impurities.
The current recall shows that the N-nitroso-duloxetine levels found in the antidepressant medication bottles were “above the proposed interim limit.” The recall is also voluntary and was initiated by the drug manufacturer, Towa Pharmaceutical Europe.
The FDA also states this is a Class II recall, which means “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Duloxetine is notably used as an antidepressant medication but also manages anxiety and nerve pain associated with diabetes, osteoarthritis, and fibromyalgia. Drugs.com notes that other brand names include Drizalma Sprinkle, and Irenka. It is in the Serotonin-norepinephrine reuptake inhibitors drug class.
In a statement to Newsweek, the FDA shared more details about the antidepressant medication recall. “There are multiple reasons why nitrosamines can be present in drugs,” the agency explained. “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 continued, “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 FDA Advises Patients to Not Stop Taking Antidepressant Medications Amid Recall
FDA further advised patients taking prescription medication with potential nitrosamine impurities to not stop taking their medications.
“Patients should take to their health care professionals about concerns and other treatment options,” the federal agency stated. “The agency is working to determine the source of these impurities and will keep the public informed.”
The FDA also reports that the chemical found in the recalled antidepressant medication, nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”
Meanwhile, the agency concluded that “a person taking a drug that contains nitrosamines at or below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.”