If you are currently on the antidepressant duloxetine with the brand name Cymbalta, there is a significant recall of this medication that you must know about. The Food and Drug Administration (FDA) has announced the recall of thousands of bottles of duloxetine owing to potential health risks. Here is what you need to know to keep healthy.
Why was Duloxetine recalled?
The FDA recalled over 7,100 bottles of duloxetine delayed-release capsules due to the presence of nitrosamines, chemicals that can be harmful at high levels. According to the FDA’s October 11th report, nitrosamines can potentially cause cancer if people are exposed to them for prolonged periods. These chemicals are commonly found in water and certain foods, but the FDA limits their concentration in medications to reduce health risks.
- Duloxetine was found to contain N-nitroso-duloxetine, a type of nitrosamine.
- The recall involves bottles from lot number 220128, with an expiration date of December 2024.
- The recall is classified as a Class II recall, meaning there could be temporary or medically reversible health effects.
What are the health risks of Nitrosamines?
Nitrosamines, including N-nitroso-duloxetine, can form during the manufacturing or storage of drugs. While they are found in everyday products like water and food, prolonged exposure at high concentrations can increase the risk of cancer. The FDA monitors nitrosamine levels in medications and issues recalls when limits are exceeded.
In the case of duloxetine, the presence of nitrosamines above the acceptable level raised concerns. Although the risk of immediate harm is low, long-term exposure is what makes it potentially dangerous.
Should you stop taking Cymbalta?
If you are currently taking duloxetine or Cymbalta, the FDA advises not to stop taking your medication suddenly. Stopping an antidepressant without medical supervision can lead to serious side effects or a relapse in your condition.
Here is what you should do instead:
- Talk to your doctor. Discuss your concerns with your healthcare provider, who can guide you on alternative treatments or next steps.
- Do not throw away your medication just yet. Your doctor will let you know if switching medications is necessary.
- Stay informed. Keep an eye on updates from the FDA about further developments.
Which lot numbers are affected?
The recall specifically targets duloxetine bottles with the lot number 220128. If you have this batch at home, check the bottle label for the lot number and expiration date (December 2024). If your prescription is from this lot, contact your pharmacy for guidance on returning the medication and getting a replacement.
What should you do if you are affected?
- Contact your healthcare provider to discuss your treatment plan.
- Check your medication bottle for the affected lot number (220128).
- Reach out to your pharmacy for possible replacements or refunds.
How is the FDA responding?
The FDA is actively working with the manufacturer to address the issue. They are investigating the source of the nitrosamine impurities to prevent future contamination. The agency will continue to monitor the situation and keep the public informed of any updates.
In the meantime, patients should stay in communication with their healthcare providers and follow their advice on managing their antidepressant treatment.
