Antidepressant Duloxetine Recall Issued by FDA
What is Duloxetine?
Duloxetine is an antidepressant medication used to treat depression, anxiety, and chronic pain. It is marketed under the brand name Cymbalta.
Why was Duloxetine Recalled?
The Food and Drug Administration (FDA) issued a recall of all lots of Duloxetine delayed-release capsules on December 13, 2023, due to the presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA) above acceptable levels.
What is NDMA?
NDMA is a probable human carcinogen (a substance that could cause cancer) that can potentially cause harm if ingested at high levels. The FDA has set acceptable daily intake limits for NDMA in medications.
Who is Affected by the Recall?
The recall affects all patients taking Duloxetine delayed-release capsules, regardless of the dosage or manufacturer. Patients should stop taking the medication immediately and consult with their healthcare providers for alternative treatment options.
What Should Patients Do?
Patients taking Duloxetine delayed-release capsules should:
- Stop taking the medication immediately.
- Contact their healthcare provider for alternative treatment options.
- Return any unused medication to the pharmacy.
What are the Risks of NDMA Exposure?
The FDA has stated that the levels of NDMA in the recalled Duloxetine lots are not expected to cause immediate health risks. However, long-term exposure to high levels of NDMA may increase the risk of cancer.
What is the FDA Doing?
The FDA is investigating the source of the NDMA impurity and working with manufacturers to ensure the safety of all medications. They are also providing guidance to healthcare providers and patients on the recall.
Additional Information
For more information on the Duloxetine recall, please visit the FDA website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/duloxetine-delayed-release-capsules-recall.
