Tejal Somvanshi
Rising Pharmaceuticals has initiated a nationwide recall of 7,107 bottles of duloxetine after discovering contamination with N-nitroso-duloxetine, a chemical compound linked to cancer risks. The recall, classified as Class II by the FDA on November 19, 2024, affects 20 mg capsules of the widely prescribed antidepressant.
The FDA explains that N-nitroso-duloxetine can form during manufacturing, storage, or packaging processes. “FDA, in collaboration with regulatory counterparts around the world, has set internationally recognized acceptable daily intake limits for nitrosamines. Nitrosamines below this level are acceptable in drugs. If drugs contain levels of nitrosamines above the acceptable daily intake limit, the FDA recommends these drugs be recalled by the manufacturer.,” the agency stated.
More than 18 million Americans receive duloxetine prescriptions annually for treating depression and anxiety, largely from the Cymbalta, the brand-name version under question. The medication, part of the selective serotonin and norepinephrine reuptake inhibitors (SSNRIs) family, increases the activity of serotonin and norepinephrine in the brain.
N-nitroso-duloxetine belongs to the nitrosamine chemical group. “There are multiple reasons why nitrosamines can be present in drugs,” the FDA noted. “FDA found the source of nitrosamines can be related to the drug’s manufacturing process, its chemical structure, or even the conditions in which they are stored or packaged.”
Higher concentrations and long-term exposure to nitrosamines may increase the risks of throat, stomach, lung, brain, kidney, and bladder cancers. The FDA continues monitoring nitrosamine levels in medications while researching potential contamination sources.
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This action follows an October 2024 recall of Cymbalta manufactured by Towa Pharmaceutical Europe, which affected over 7,000 bottles of 20-milligram tablets for the same contamination issue.
The FDA emphasizes that patients taking prescription medications with potential nitrosamine impurities should consult their healthcare providers before stopping treatment. Sudden discontinuation of duloxetine can cause withdrawal symptoms including mood swings, aches, pains, chills, and fatigue due to rapid changes in serotonin levels.
The Class II designation indicates potential “temporary or medically reversible adverse health consequences” with a remote probability of serious health impacts. The FDA has established interim acceptable daily intake limits for nitrosamine compounds in pharmaceuticals.
Rising Pharmaceuticals, based in New Jersey, initiated the voluntary recall after detecting N-nitroso-duloxetine levels exceeding recommended interim limits. No related illnesses have been reported till now.
