DULOXETINE, a widely used and popular antidepressant, has been recalled by U.S. Food and Drug Administration (FDA) due to the detection of N-nitroso-duloxetine, a chemical suspected of being carcinogenic. This recall, classified as Class II, indicating that exposure to the drug may lead to temporary or medically reversible health issues, affects over 7,100 bottles of the drug’s delayed-release capsules manufactured by Towa Pharmaceutical Europe, Spain.
Marketed under brand names such as Cymbalta, Drizalma Sprinkle, and Irenka, duloxetine is commonly prescribed for depression, anxiety, diabetic nerve pain, fibromyalgia, and chronic musculoskeletal pain. The FDA’s investigation indicates that the presence of nitrosamines like N-nitroso-duloxetine can arise from various factors, including the drug’s manufacturing process, chemical structure, and storage conditions.
While the FDA assures that the likelihood of serious health consequences is low, it emphasizes the importance of patient safety. The agency advises patients not to discontinue their medications abruptly and to consult healthcare providers for guidance on alternative treatments. “Patients taking prescription medications with potential nitrosamine impurities should not stop taking their medications,” the FDA stated.
As healthcare providers, it is essential to communicate these developments to patients who may be affected by the recall and to explore alternative treatment options as the FDA continues its investigation into the source of these impurities. Regular updates from the FDA will provide further clarity on the situation as it evolves.
Reference: Vice. Antidepressants recalled over potentially cancer-causing chemical. October 22, 2024. Available at: https://www.vice.com/en/article/antidepressants-recalled-over-potentially-cancer-causing-chemical/. Last accessed: October 25, 2024.
Anaya Malik | AMJ
