Wait, What? Popular Antidepressant Pulled from Shelves Over Cancer Risk

Duloxetine, a widely prescribed antidepressant often sold under brand names like Cymbalta, has been voluntarily recalled in the United States due to concerns about a potentially cancer-causing chemical, N-nitroso-duloxetine. This chemical is part of the nitrosamine group, substances found in food and water but considered harmful when present in higher concentrations for extended periods.

What Happened?

Faceless woman with pill in teeth and nose piercing | Duloxetine | cymbalta antidepressant

The recall affects over 7,100 bottles of duloxetine delayed-release capsules, particularly those in 20 mg doses with a specific lot number and expiration date. These were manufactured by Towa Pharmaceutical Europe and distributed across the U.S. The issue stems from N-nitroso-duloxetine levels exceeding FDA limits, which has led to its classification as a Class II recall. This designation means the risk of severe health consequences is low but not negligible.

What Is N-nitroso-duloxetine?

Nitrosamines, including N-nitroso-duloxetine, can form during the manufacturing or storage of medications. The FDA monitors their presence because prolonged exposure can increase cancer risks. These impurities can arise from chemical reactions in the drug production process or packaging.

Should Patients Be Concerned?

The FDA strongly advises patients not to stop taking duloxetine abruptly, as doing so could lead to antidepressant discontinuation syndrome. Symptoms of this condition include nausea, insomnia, fatigue, and irritability. Instead, patients should consult their healthcare providers to discuss alternative treatments or adjust their prescriptions safely.

Why This Recall Matters

This recall highlights a broader issue of nitrosamine contamination in pharmaceuticals, an ongoing challenge for regulators. The FDA continues to investigate these impurities to ensure public safety. It’s worth noting that duloxetine isn’t the first drug to face such scrutiny, as nitrosamine-related recalls have affected other medications like ranitidine in recent years.

What Comes Next?

While the current recall is precautionary, it serves as a reminder for patients to remain informed about their medications. The FDA will update the public as more details emerge about the source of these impurities and any further actions needed.

For patients and healthcare professionals, vigilance and open communication are essential. If you’re currently prescribed duloxetine, reach out to your doctor to address any concerns and explore safe options.