The FDA recently issued a recall for over 7,000 bottles of duloxetine, an antidepressant also known by its brand name, Cymbalta. The recall was prompted by the detection of nitrosamines, specifically N-nitroso-duloxetine, a type of potentially carcinogenic compound.
Duloxetine, an SNRI class medication, is commonly prescribed for depression and anxiety, and this recall impacts the 20 mg delayed-release capsules in specific batches distributed across the United States.
The presence of nitrosamines raises health concerns due to their potential cancer risks, although the FDA’s classification of this recall as Class II indicates that it may only cause temporary or reversible health effects and is unlikely to lead to serious adverse outcomes.
Nitrosamines, according to the FDA, are organic compounds that are commonly found in trace amounts in various foods and water. While everyone is exposed to low levels of nitrosamines, prolonged or high-level exposure may increase the risk of cancer.
The FDA has set a safety threshold, indicating that people can consume nitrosamines at low levels daily over a lifetime (around 70 years) without significantly raising cancer risks. However, during drug manufacturing and packaging, nitrosamines can form unintentionally, necessitating strict monitoring to prevent excessive levels.
The recall affects specific bottles of duloxetine with lot #220128, which are set to expire in December 2024. If patients are taking this antidepressant, they are advised to check their medication’s lot number to determine if it falls under the recall. Pharmacies can help verify if a patient’s specific batch is affected and may provide alternative, uncontaminated duloxetine options if needed. This measure ensures patients can continue their medication without the added risk of nitrosamine exposure.
It’s essential for patients not to discontinue duloxetine abruptly due to the recall, as stopping antidepressant medication suddenly can have significant health risks. The FDA advises consulting with healthcare providers to discuss any concerns before making changes to the medication regimen. In many cases, the risk of untreated depression or anxiety may outweigh the potential, relatively low risk posed by the recalled duloxetine, given its classification.
For further guidance, patients are encouraged to reach out to the FDA’s Division of Drug Information or consult with their pharmacy or healthcare provider. This communication channel is available to address any concerns related to duloxetine or other medications affected by similar recalls due to nitrosamine contamination.
