In a recent announcement, the U.S. Food and Drug Administration (FDA) has issued a Class II recall for more than 7,000 bottles of the popular antidepressant duloxetine, sold under the brand name Cymbalta. The recall was initiated on October 10 due to the presence of a potentially harmful chemical impurity, raising concerns among consumers who rely on this medication for treating conditions like anxiety and depression.
What Triggered the Recall?
The recall was prompted by the discovery of N-nitroso-duloxetine, a type of nitrosamine impurity found in the medication. Nitrosamines are chemicals that can be present in small amounts in various everyday products, including food, water, and medications. While nitrosamines are usually harmless at low levels, long-term exposure to elevated amounts can potentially increase the risk of cancer.
According to the FDA, nitrosamine impurities may be harmful if people are exposed to them above acceptable levels for extended periods of time. However, the agency reassures that people taking medications with nitrosamines below these limits for up to 70 years would likely not face an increased cancer risk.
Details of the Affected Medication
The recall involves 7,107 bottles of duloxetine delayed-release capsules in 20 mg strength, sold in 500-count bottles. The affected bottles come from Lot #220128, which has an expiration date of December 2024. These capsules were manufactured by Towa Pharmaceutical Europe and distributed across the United States.
The FDA categorized the recall as Class II, meaning the exposure to the impurity could cause temporary or medically reversible health consequences. However, the risk of serious adverse effects is considered remote.
What Should You Do If You’re Taking Duloxetine?
If you have been prescribed duloxetine, it’s essential to not stop taking the medication suddenly. Stopping any antidepressant without medical supervision can lead to withdrawal symptoms or a worsening of your condition. Instead, the FDA advises patients to speak with their healthcare providers about their concerns and discuss alternative treatment options if necessary.
Healthcare professionals will be able to guide you through the best steps to take, whether it’s continuing the current medication or switching to a safer alternative.
Understanding Nitrosamines
Nitrosamines are found in common foods such as grilled meats, dairy products, and even some vegetables. While most people are exposed to them in small amounts daily, excessive exposure over time can be harmful. In recent years, several medications have been recalled due to nitrosamine contamination, including Zantac (a heartburn medication), metformin (used for diabetes), and Chantix (a smoking cessation drug).
Since 2018, over 12 million bottles of blood pressure medications like valsartan and losartan have also been pulled from the market for containing high levels of nitrosamines.
Next Steps and FDA’s Investigation
The FDA is actively working to determine the source of the nitrosamine impurity in duloxetine and is keeping the public updated as more information becomes available. Towa Pharmaceutical Europe, the manufacturer of the affected capsules, has directed consumers to the FDA’s website for further details about nitrosamine impurities.
For now, patients are urged to stay informed, consult their doctors, and not panic over the recall. While the impurity is concerning, the FDA assures that the risk of immediate harm remains low.