It's estimated that at least one in eight Americans take an antidepressant. Doctors prescribe these medicines to treat depression and anxiety, and in many cases, they can truly turn someone's life around. That's why it's so distressing to learn of a new drug recall issued by the U.S. Food and Drug Administration (FDA) in which 7,100 bottles of the antidepressant Duloxetine, distributed under the brand name Cymbalta, are being pulled for containing a potentially cancer-causing chemical.
In addition to depression, Duloxetine treats "pain caused by nerve damage associated with diabetes," as well as fibromyalgia and chronic pain, according to Mayo Clinic. Duloxetine is part of a drug class known as SSNRIs, selective serotonin and norepinephrine reuptake inhibitors, which are thought to work by increasing the amount of the neurotransmitters serotonin and norepinephrine in the brain.
Per the FDA notice, the medication was manufactured by Towa Pharmaceutical Europe and distributed nationwide. The recall concerns 500-count bottles of 20-mg delayed-release pills with lot number 220128 and an expiration date of Dec. 2024.
The FDA found that the Duloxetine pills contain more than the allowed limit of N-nitroso-duloxetine (NDLX), a chemical that is suspected of causing cancer, according to the National Library of Medicine.
For this reason, the FDA categorizes it 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."
"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 to Newsweek. "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."
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It's important to note that people may experience Antidepressant Discontinuation Syndrome (ADS) if they abruptly stop taking their medication, especially if they've been on it for at least six weeks. Cleveland Clinic explains that this may cause nausea, insomnia, fatigue, and achiness. In such cases, doctors may recommend that patients taper off their antidepressants.
Therefore, in their statement to Newsweek, the FDA said that "patients taking prescription medications with potential nitrosamine impurities should not stop taking their medications." Instead, they recommend speaking to one's healthcare provider "about concerns and other treatment options."
"The agency is working to determine the source of these impurities and will keep the public informed," officials added.
