An antidepressant medication named duloxetine has been recalled by the U.S. Food and Drug Administration (FDA) due to the presence of carcinogenic chemicals.
The drug was voluntarily recalled by a New Jersey-based distributor, Rising Pharmaceuticals, Inc., on November 19, due to the "presence of N-nitroso-duloxetine impurity above recommended interim limit."
Duloxetine is an antidepressant medication classified as a serotonin-norepinephrine reuptake inhibitor (SNRI). It is often prescribed to manage major depressive disorder by balancing chemicals in the brain, and is also used to treat generalized anxiety disorder.
Stock image of a man taking medication. An antidepressant named duloxetine was recalled due to potential impurities.Stock image of a man taking medication. An antidepressant named duloxetine was recalled due to potential impurities.ISTOCK / GETTY IMAGES PLUSDuloxetine works by affecting two key neurotransmitters in the brain: serotonin and norepinephrine.
Serotonin plays a role in mood regulation, anxiety, and emotional stability, while norepinephrine affects pain perception and alertness.
By blocking the reuptake of these neurotransmitters, duloxetine increases their levels in the brain, which helps regulate mood in conditions like depression and anxiety.
The drug also modifies how pain signals are processed in the central nervous system, and is also often prescribed to treat neuropathic pain caused by conditions such as diabetes, fibromyalgia and chronic musculoskeletal pain.
The recalled medications were subsequently issued a Class II risk level, which are given when "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," according to the FDA.
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233,003 of the 60 mg Duloxetine 30-count, 90-count and 1000-count bottles were involved in the recall.
The recall was initiated due to the presence of N-nitroso-duloxetine, which is a type of nitrosamine impurity. Nitrosamines are classified as probable human carcinogens, with long-term exposure potentially increasing the risk of developing cancer.
Nitrosamines can form unintentionally during manufacturing, storage, or interaction with other substances. Regulatory agencies like the FDA and EMA set strict limits on nitrosamine levels in medications, and if a product exceeds these limits, it may be deemed unsafe for consumption, prompting a recall.
Another company—Towa Pharmaceutical Europe—recalled its duloxetine products in October due to the same issue.
"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 at the time.
"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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