The US Food and Drug Administration (FDA) announced a major drug recall on October 10, covering 7,107 bottles of the antidepressant drug. The drug, commonly known as duloxetine (brand name Cymbalta), is used to treat mental health problems, such as anxiety and depression, among other ailments, the Cleveland Clinic reports. This medicine is manufactured by Towa Pharmaceutical Europe and distributed throughout the country.
The FDA pointed out that the drug contained a nitrosamine compound called N- nitroso- duloxetine as an impurity. Nitrosamine impurities, if exposed in large amounts and over long periods of time, may increase the risk of cancer, the FDA says. However, the agency explained that if any drug contains trace amounts of nitrosamine impurities and is taken daily for 70 years, there is no increased risk of cancer.
As per FDA classification this class. There is a recall, which means that the drug has potential risks of temporary or medically reversible health problems. Therefore, the FDA has urged potential users of the drug to exercise caution. Users of this drug can contact their healthcare provider to discuss switching the drug, the FDA’s website says.
According to the FDA, nitrosamines are found in water, canned and grilled meats, dairy products, and some vegetables. Normally everyone is exposed to it in small amounts, but long- term and large exposures can increase the risk of cancer. Since 2018, more than 12 million bottles of antihypertensive drugs such as valsartan and losartan have been recalled due to nitrosamines. Heartburn drug Ontac, diabetes drug Metformin and smoking cessation drug Chatix have also been recalled due to similar impurities.
The FDA urges people to stop taking drugs related to these impurities and discuss them with their health care professionals.