Demand All Antidepressants Checked for Cancer After Duloxetine Recall US-Wide

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The Issue

NJ-based Breckenridge Pharmaceuticals is recalling bottles of duloxetine — a generic version of Cymbalta used to treat depression, anxiety, and fibromyalgia — after testing found levels of a cancer-causing compound called N-nitroso-duloxetine above the FDA's recommended limit. The contaminated capsules were distributed nationwide. Millions of Americans take duloxetine every day.

This is not the first time a widely used medication has been found to contain nitrosamine contamination. In recent years, nitrosamine impurities have triggered recalls of blood pressure medications, heartburn drugs, and diabetes medications. Each time, the pattern is the same: a drug reaches patients, contamination is discovered after the fact, and a recall is issued weeks or months after people have already been exposed.

Nitrosamines are compounds that can form during the manufacturing, storage, or packaging of medications. Long-term exposure above safe limits increases the risk of cancer. People taking antidepressants are not taking them occasionally — they are taking them every single day, often for years. The cumulative exposure risk is real and serious.

The FDA must not wait for the next recall to act. Every antidepressant currently on the market — generic and branded — should be tested for nitrosamine contamination now. Patients managing depression, anxiety, and other mental health conditions deserve to know that their medication is safe. They cannot simply stop taking it while they wait for answers.

We're calling on the FDA to immediately mandate comprehensive nitrosamine testing across all antidepressant medications on the US market and publish the results publicly so patients and doctors can make informed decisions.

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