The U.S. Food and Drug Administration (FDA) has announced a Class II recall of over 7,000 bottles of duloxetine, a widely used antidepressant, because of the presence of a potentially cancer-causing chemical impurity. The recall was initiated on October 10, 2024, after the discovery of N-nitroso-duloxetine, a type of nitrosamine impurity, in the medication. Nitrosamines are chemicals commonly found in trace amounts in various foods and water, but long-term exposure to higher levels has been linked to an increased risk of cancer.
Duloxetine, commonly sold under brand names like Cymbalta, is prescribed for the treatment of anxiety, depression, and some chronic pain conditions. The FDA’s findings have raised concerns about the safety of the affected medication, specifically the duloxetine delayed-release capsules. The recall involves lot number #220128, with an expiration date of December 2024, totaling 7,107 bottles. This is classified as a Class II recall, which means that the product might cause “temporary or medically reversible” adverse health effects, though the likelihood of serious harm is considered low.
Nitrosamines have been a recurring issue in the pharmaceutical industry, leading to previous recalls of other medications such as valsartan, a blood pressure medication, Zantac, used for heartburn relief, and metformin, which treats diabetes. Although nitrosamines occur naturally in the environment, the FDA has established acceptable daily intake limits for these impurities in drugs to minimize the potential cancer risk from long-term exposure.
The FDA noted that taking medications containing low levels of nitrosamines is not expected to be harmful. However, prolonged exposure above the established safety limits can increase cancer risk. In the case of duloxetine, the impurity levels detected in the affected lot exceeded what is considered acceptable, prompting the recall.
For patients currently taking duloxetine from the recalled lot, the FDA advises discontinuing use immediately and consulting with a healthcare professional for guidance on alternative treatment options. It is crucial for patients not to stop their medication without first discussing it with a healthcare provider, as abruptly discontinuing an antidepressant can lead to withdrawal symptoms or a resurgence of anxiety and depression symptoms.
Healthcare providers can assist in determining if a patient’s prescription is from the affected lot and can recommend an alternative antidepressant if necessary. Pharmacists are also being informed of the recall to help guide patients in identifying and replacing the recalled product.
The FDA’s recall of duloxetine is part of a larger trend of nitrosamine-related recalls in recent years. As pharmaceutical companies work to improve manufacturing processes and detect impurities more effectively, the FDA continues to monitor the presence of nitrosamines in various drugs. For patients, the agency’s recommendations highlight the importance of consulting healthcare professionals regarding any concerns about medication safety.
While the risk from the duloxetine recall is considered low, the incident serves as a reminder for consumers to stay informed about medication recalls and follow up with their healthcare providers. For those who have been taking the affected lot of duloxetine, medical consultation is essential to ensure continued safety and effective management of their mental health conditions.
For more details on the recall and updates, patients and healthcare providers can visit the FDA’s official website or contact their pharmacy for assistance.