Duloxetine Recall: Hidden Risks Prompt FDA Action – Key Information Inside

Stethoscope, pills, pen, magnifying glass with Product Recall.

The FDA’s recent recall of over 7,000 bottles of duloxetine capsules has sent ripples through the healthcare community. The recall raises crucial questions about patient safety and treatment continuity. The FDA urges duloxetine users to check their prescriptions.

The FDA Recall and Its Implications

The FDA’s recall involves 7,107 bottles of duloxetine delayed-release capsules, affected by the presence of nitrosamine N-nitroso-duloxetine, a potential carcinogen.

This antidepressant, also known under the brand Cymbalta, treats depression, anxiety, and neuropathic pain conditions. The recall applies solely to 500-count bottles of 20mg capsules manufactured by Towa Pharmaceutical Europe with lot number 220128, expiring in December 2024.

Breckenridge Pharmaceutical initiated the recall after discovering impurity levels that exceeded acceptable limits set by the FDA. As a class II recall, it poses low risks or reversible health consequences. The FDA’s guidance urges healthcare professionals to explore alternative therapies, while pharmacists should ensure the availability of unaffected duloxetine.

Concerns Over Nitrosamine Impurities

N-nitroso-duloxetine surpasses the proposed interim limits, posing toxicological concerns and a cancer risk upon prolonged exposure above safe levels.

Nitrosamine concerns extend beyond duloxetine, with numerous drug recalls, including metformin and skeletal muscle relaxants, reflecting broader issues linked to manufacturing processes or storage conditions.

Patient and Healthcare Provider Guidance

The FDA hasn’t provided detailed handling instructions for recalled duloxetine but advises patients to consult healthcare providers regarding treatment safety.

The FDA underscores that risks from ceasing duloxetine may outweigh those from nitrosamine exposure, so patients should coordinate closely with their pharmacists to verify if their specific medication lot is unaffected.

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