In a significant development affecting over 550,000 bottles of duloxetine, the U.S. Food and Drug Administration (FDA) has issued a recall due to concerns over the presence of a potential carcinogenic impurity. The recall was prompted by the detection of N-nitroso-duloxetine at levels exceeding the recommended interim limit. The FDA has classified this recall as a "class II" risk level, indicating the second most severe category of FDA recalls. This classification reflects potential adverse health effects associated with long-term exposure to the impurity.
Duloxetine, a widely used medication for treating anxiety, depression, chronic pain, and other conditions, has come under scrutiny due to the impurity. Individuals taking duloxetine for extended periods may accumulate higher-than-expected levels of N-nitroso-duloxetine in their bodies. Nitrosamines, such as N-nitroso-duloxetine, are compounds that can damage DNA and potentially cause cancer in humans. This impurity likely infiltrates duloxetine during the manufacturing or storage process, posing a health risk.
The recall encompasses various doses of duloxetine delayed-release capsules manufactured by Rising Pharma, Inc., as well as 500-count 20 mg capsules produced by Towa Pharmaceutical Europe. Notably, not all formulations of duloxetine are included in the current recall. Duloxetine is the generic equivalent of brand-name drugs Cymbalta and Irenka and is prescribed for depression in adults and generalized anxiety disorder in both adults and children over seven years old. Furthermore, it is utilized to alleviate pain from fibromyalgia or nerve damage resulting from diabetes.
The FDA's action highlights the urgent need for patients using duloxetine to consult their healthcare providers. As Jamie Alan, PhD, an associate professor of pharmacology and toxicology at Michigan State University, advises:
"Be sure to speak to your healthcare provider, to appropriately taper this medication."
Dr. Alan emphasizes the challenges that can arise from withdrawing from medications used for depression or neuropathic pain:
"Withdrawal from this type of medication, whether used for depression or neuropathic pain or something else, can be challenging."
Kelly Johnson-Arbor, MD, a toxicologist at MedStar Health, underscores the risk posed by nitrosamines:
"Especially when people are exposed to the chemicals in high doses or for extended periods of time."
The contamination of duloxetine with N-nitroso-duloxetine presents significant concerns. It is crucial for individuals currently on duloxetine therapy to seek medical advice to manage their medication safely. This recall serves as a reminder of the importance of rigorous quality control measures in pharmaceutical production and storage.
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