The Food and Drug Administration (FDA) has announced a recall of another commonly prescribed antidepressant due to potential cancer-causing chemicals. On November 19, Rising Pharma, Inc., recalled several doses of duloxetine delayed-release capsules because they contained an impurity called N-nitroso-duloxetine above the interim limit recommended by the FDA. Over 550,000 bottles were part of this recall, which was classified as “class II,” the FDA’s second highest risk level, as of December 5.
Duloxetine, the generic form of Cymbalta and Irenka, is used to treat depression in adults and generalized anxiety disorder in adults and children over seven. It is also prescribed for pain relief from fibromyalgia or nerve damage due to diabetes.
Here’s what you should know about this recall:
The affected products include:
– Duloxetine Delayed-Release Capsules USP, 20 mg, 60-count bottles
– Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles
– Duloxetine Delayed-Release Capsules USP, 30 mg, 90-count bottles
– Duloxetine Delayed-Release Capsules USP, 30 mg, 1,000-count bottles
– Duloxetine Delayed-Release Capsules USP, 60 mg, 30-count bottles
– Duloxetine Delayed-Release Capsules USP, 60 mg, 90-count bottles
– Duloxetine Delayed-Release Capsules USP, 60 mg, 1,000-count bottles
According to FDA reports, the impurity, N-nitroso-duloxetine, might occur during the manufacturing or storage process. Nitrosamines, like N-nitroso-duloxetine, can damage DNA and are considered potential cancer risks when people are exposed to them in large amounts or over long periods. Since duloxetine is used for chronic conditions, those taking it for extended durations might accumulate higher levels of this impurity, posing health risks.
This isn’t the first recall for duloxetine due to similar impurities. In October, over 7,000 bottles of a different formulation were also recalled. However, not all duloxetine products are affected by this latest recall. It’s crucial for those taking the medication to check their labels and the recall notice to determine if their prescription is impacted.
If you’re uncertain about whether your duloxetine is part of the recall, consult your pharmacist for guidance. If affected, it’s important to reach out to your doctor or pharmacy about alternative treatments. However, you should not stop taking the medication without professional advice, as withdrawal can be challenging and include symptoms like irritability, nausea, dizziness, and headaches. Consult your healthcare provider to ensure a safe and gradual discontinuation if necessary.
