Over 7,000 Bottles of Antidepressant Recalled Over Cancer Risk

Over 7,000 Bottles of Antidepressant Recalled Due to Cancer Risk

Overview of the Recall
The Food and Drug Administration (FDA) has issued a recall of over 7,000 bottles of duloxetine, an antidepressant commonly sold under the brand name Cymbalta. This medication, which is also used to treat anxiety and nerve pain, has been found to contain potentially harmful levels of nitrosamines, a known carcinogen. The recall concerns bottles of 500-count, 20 mg delayed-release duloxetine tablets that were distributed across the country.

What Are Nitrosamines and Why Are They a Concern?
Nitrosamines are organic compounds that naturally occur in small quantities in various foods and water, including meat, dairy, and vegetables. While exposure to low levels of nitrosamines is generally considered safe, prolonged exposure to high concentrations may increase the risk of cancer. The specific nitrosamine detected in this batch of duloxetine is called N-nitroso-duloxetine, which can form during the manufacturing process or while the drug is stored.

FDA’s Assessment and Recall Details
The FDA categorized this recall as a Class II recall, indicating that the health risks posed by the contaminated medication are temporary and medically reversible. This means that while the contamination is a concern, it is unlikely to lead to serious long-term health problems. The recall was initiated after testing revealed that the affected lot of duloxetine tablets might have higher-than-acceptable levels of nitrosamines.

What to Do if You Take Duloxetine
If you are currently taking duloxetine, it is important to check whether your medication is from the affected batch. The recalled lot number is #220128, with an expiration date of 12/2024. If your medication is part of the recall, you should consult your pharmacist. They can confirm whether your medication is affected and may be able to provide an alternative that is not part of the recall. However, it is crucial not to stop taking your medication without consulting your healthcare provider, as discontinuing the drug suddenly could have adverse health effects.

Why You Shouldn’t Stop Your Medication Without Consulting a Doctor
The FDA advises against abruptly stopping the use of duloxetine, as doing so could be harmful. The risks of discontinuing the medication could outweigh the potential harm from the nitrosamine exposure. Always consult your healthcare provider before making any changes to your medication regimen.

Key Takeaways

• Over 7,000 bottles of duloxetine have been recalled due to the presence of nitrosamines, which could increase the risk of cancer.

• The recall affects 500-count, 20 mg delayed-release duloxetine tablets from lot #220128, expiring in December 2024.

• If you are taking duloxetine, check with your pharmacist to see if your medication is part of the recall, but do not stop taking it without consulting your doctor.

For Further Questions
If you have concerns about the safety of duloxetine or other medications, you can contact the FDA’s Drug Information Center or speak with your pharmacy or healthcare provider.