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The U.S. Food and Drug Administration recalled thousands of bottles of antidepressants due to the medicines containing high levels of a cancer-causing chemical.
Now, the FDA is assigning the second-highest risk level to the recall of Duloxetine Delayed-Release Capsules produced by Towa Pharmaceutical Europe.
The capsules were designated as a Class II recall, “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.”
Duloxetine is used to treat depression, anxiety and nerve pain caused by fibromyalgia.
However, low levels of a cancer-causing chemical called N-nitroso-duloxetine have been discovered during routine production checks.
These chemicals are commonly found in water and food products, but the FDA regulates how much of this chemical can be present in certain items because at high levels the chemicals can cause harm.
The FDA is looking into the source of the medications’ impurities. In the meantime, the organization is advising patients who have been prescribed these medications not to stop taking them until they have talked to a health care professional about their concerns and potentially exploring other treatment options.
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