- The FDA issued a recall notice for more than 7,000 bottles of duloxetine, a drug used to treat depression, anxiety, and nerve pain.
- The recalled lot may contain high levels of nitrosamines, a carcinogenic compound.
- The recall is Class II, meaning the health harms associated with taking the tainted medication are likely temporary or medically reversible, and it’s unlikely to cause serious health outcomes.
The recent recall initiated by the Food and Drug Administration (FDA) has raised important concerns regarding the antidepressant duloxetine, commonly known by its brand name, Cymbalta. This recall affects over 7,000 bottles of the medication due to the detection of nitrosamines, specifically a compound called N-nitroso-duloxetine, which is known to pose a cancer risk.
What is Duloxetine?
Duloxetine is a widely used medication classified as a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is primarily prescribed for conditions such as depression, anxiety, and nerve pain. The recent recall, announced on October 10, indicates that the specific lot, which contains 500-count, 20 mg delayed-release capsules, may expose patients to potentially harmful levels of nitrosamines.
Understanding Nitrosamines
Nitrosamines are organic compounds that typically occur in low levels in food and water, including meats, dairy products, and some vegetables. According to the FDA, everyone encounters small amounts of nitrosamines in their daily lives. The regulatory agency further notes that exposure at or below safety thresholds for up to 70 years likely does not increase cancer risk; however, prolonged exposure to elevated levels could heighten this risk.
The contamination in this instance arises from the manufacturing and storage processes where nitrosamines can inadvertently form.
What to Do If You Take Duloxetine
If you are currently taking duloxetine, it’s vital to verify whether your medication is part of the affected batch. The specific lot number to check is #220128, which expires in December 2024.
If you have concerns, reach out to your pharmacy. They can confirm whether your specific batch is included in the recall and can help provide alternatives if necessary. It is also critical to consult your healthcare provider before discontinuing the medication, as halting it abruptly could have consequences that outweigh the potential risks related to nitrosamines.
What This Means for You
For more detailed inquiries regarding the safety of duloxetine or any other medications, consider reaching out to the FDA’s Division of Drug Information or speak directly with your pharmacy or healthcare provider. They are equipped to provide guidance and support in navigating this recall effectively.
As always, keeping yourself informed about medication safety is essential for your health and well-being.
3 Other Sources
Markimugan uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles.
- Food and Drug Administration. Recalls background and definitions.
- Food and Drug Administration. Information about nitrosamine impurities in medications.
- Food and Drug Administration. What to know and do about possible nitrosamines in your medication.
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