FDA issues urgent recall of duloxetine due to presence of toxic carcinogen

The U.S. Food and Drug Administration (FDA) has ordered the recall of over 7,000 bottles of the antidepressant duloxetine, sold under the brand name Cymbalta, after discovering the presence of a potentially cancer-causing chemical. The recall affects bottles with lot number 220128 and an expiration date of December 2024.

Toxic chemical linked to cancer found in duloxetine

The contaminant identified is N-nitroso-duloxetine, a chemical classified as a carcinogen that may pose a cancer risk if ingested in significant amounts. The recall has been categorized as a Class II, meaning that while the drug may cause “temporary or medically reversible adverse health consequences,” it is unlikely to result in serious harm if consumed under standard dosing guidelines.

Duloxetine is commonly prescribed to treat depression, anxiety, fibromyalgia, and chronic pain. However, concerns arose when the chemical N-nitroso-duloxetine, known to form under certain production or storage conditions, was detected.

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FDA warns of nitrosamine impurities in drugs

In a statement to Newsweek, the FDA explained that nitrosamines can form due to various factors, including manufacturing processes, chemical structure, or storage conditions. The agency emphasized the importance of limiting exposure to nitrosamines, as long-term ingestion can elevate cancer risk.

The FDA encourages anyone who has been taking the recalled medication to consult their healthcare provider to determine the best course of action. While the immediate health risks are considered low, patients should not discontinue use without medical advice.

What to do if you’ve taken the recalled medication

For those concerned about exposure, the FDA advises speaking with a doctor to discuss potential risks and alternative treatment options. They continue to investigate the issue and are testing additional batches of the medication to prevent further incidents.

As a reminder, duloxetine is part of the serotonin-norepinephrine reuptake inhibitor (SNRI) class of antidepressants and is used to treat various conditions including major depressive disorder and generalized anxiety disorder.