Thousands of bottles of antidepressants have been recalled across the U.S. after they were found to contain levels of a potentially cancer-causing chemical above the acceptable limit as set out by the U.S. Food and Drug Administration.
The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on October 10 and has been given the second highest risk classification by the FDA.
Duloxetine is a medication used to manage depression, anxiety, and nerve pain, such as fibromyalgia. It works by increasing levels of mood-boosting chemicals in the brain. However, during its production, low levels of a chemical called N-nitroso-duloxetine can also be produced.
This chemical belongs to a group of chemicals called nitrosamines that are commonly found in water and food products. However, when they are present in higher concentrations, and we are exposed to them for an extended period of time, these chemicals may increase our risk of developing cancer. As a result, their concentrations are strictly limited by the FDA.
“There are multiple reasons why nitrosamines can be present in drugs. FDA found the source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged,” the FDA said in a statement. “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.”
In the present recall, N-nitroso-duloxetine levels were “above the proposed interim limit” in the products tested. The recall was voluntary and initiated by Towa Pharmaceutical Europe. Newsweek has contacted Towa Pharmaceutical by email.
Details of the product in question are shown below:
On October 11, the recall was classified as a class II recall by the FDA—a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
“Patients taking prescription medications with potential nitrosamine impurities should not stop taking their medications,” the FDA said. “Patients should talk to their health care professionals about concerns and other treatment options.
“The agency is working to determine the source of these impurities and will keep the public informed.”
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