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Antidepressant recalled due to presence of potentially cancer-causing impurity
Yahoo • • business
Key Points:
- Thousands of bottles of the antidepressant duloxetine have been voluntarily recalled due to the presence of N-nitroso-duloxetine, an impurity exceeding FDA safety limits and potentially linked to cancer risk.
- Duloxetine, used to treat depression and anxiety, is distributed by Breckenridge Pharmaceutical Inc. and manufactured by Towa Pharmaceutical.
- The FDA warns that long-term exposure to nitrosamine impurities above acceptable levels may increase cancer risk, although no direct evidence links N-nitroso-duloxetine to cancer specifically.
- The recall is classified as Class II, indicating the product may cause temporary or reversible health effects, with serious consequences considered unlikely.
- The FDA and manufacturer have not provided additional comments, and consumers are advised to avoid using the affected medication.
