FDA Recalls Over 7,000 Bottles of Antidepressant Due to Cancer-Causing Chemical

The Food and Drug Administration (FDA) has issued a recall for over 7,100 bottles of the antidepressant duloxetine, which is marketed under well-known names such as Cymbalta. This recall was prompted by the detection of nitrosamines, a substance that may pose a cancer risk, in the affected batches.

The recall, categorized as a Class II recall, indicates that the use of or exposure to the non-compliant product could lead to temporary or medically reversible adverse health effects, or where the likelihood of severe adverse health consequences is low. The specific lot being recalled is lot number 220128, which is set to expire in December 2024.

According to the FDA, nitrosamines present below internationally accepted daily intake thresholds are permissible in pharmaceuticals. However, exposure to nitrosamine contaminants above these acceptable levels and over extended periods may elevate cancer risk. The FDA notes that an individual consuming a medication with nitrosamines at or below the acceptable daily intake for 70 years is not anticipated to have an increased cancer risk.

Patient advice from the FDA includes consulting healthcare providers if they have inquiries regarding their medication. The FDA emphasizes that the hazards of discontinuing treatment may outweigh the potential risks associated with nitrosamine exposure.