The U.S. Food and Drug Administration (FDA) recalled thousands of bottles of antidepressant Duloxetine across the country for potentially carrying cancer-causing chemicals. According to the FDA’s report, the recall was initiated on over 7,100 bottles of Duloxetine produced by Towa Pharmaceutical Europe. The report stated that the expiration date of the product is 12/2024 and the lot number is 220128. Moreover, the FDA gave the drug the second highest risk classification. Meanwhile, PEOPLE reported that the antidepressant is sold under the brand name Cymbalta.
FDA recalled Cymbalta’s antidepressants after cancer-causing chemicals were found
FDA recalled a total of 7,107 bottles of Duloxetine on October 10, among which 500 bottles were 20 mg delayed-release capsules. Duloxetine is used to treat mood disorders, including depression or anxiety. It is also useful in relieving nerve pain or pain due to medical conditions like fibromyalgia and arthritis, among others.
The federal agency gave Cymbalta a Class II recall. According to the FDA, this means that the recalled product could cause “temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The reason for the recall was due to the presence of “Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.” Moreover, Towa Pharmaceutical Europe voluntarily initiated the recall.
Newsweek reported that while Duloxetine increases mood-boosting chemicals in the brain, low levels of N-nitroso-duloxetine can also be produced during production. The outlet explained that these chemicals belong to a group called nitrosamines, which are usually found in food products and water. However, exposure to these chemicals for a longer period of time can increase the chances of cancer in an individual. As a result, the FDA has limited its concentrations.
In a statement to Newsweek, the FDA potentially credited the sources of nitrosamines to its chemical structure, the packaging conditions, or the manufacturing process. The federal agency continued, “As foods and drugs are processed in the body, nitrosamines can also be formed. FDA continues to test and research possible sources for drugs found to contain nitrosamines.”
Furthermore, the FDA advised patients to not stop taking prescription drugs possibly containing nitrosamine impurities. Instead, they suggested that patients consult their doctors about alternative treatment options. The agency also ensured to keep the public informed on the sources of the impurities.
