More than 233,000 bottles of an antidepressant have been recalled by public health officials due to a chemical containing the risk of cancer.
The U.S. Food and Drug Administration classified capsules of duloxetine, sold by New Jersey-based company Rising Pharmaceuticals, as a Class II risk on Dec. 5. The risk level is the FDA’s second most severe level as it could cause “temporary or medically reversible adverse health consequences.”
The bottles contain the “presence” of nitrosamine drug substance impurity, N-nitroso-duloxetine, that exceeds the recommended interim limit, according to the FDA.
Rising Pharmaceuticals, who the FDA reported issued a voluntary recall on Nov. 19, did not immediately respond to USA TODAY’s request for comment.
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The FDA states that nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.” However, it clarifies, “a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.”
In October, The FDA initially announced a Class II recall for just 7,107 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe.
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How many bottles of duloxetine were recalled?
According to the FDA, 233,003 bottles have been recalled (delayed-release capsules 30 count, 90 count and 1000 count bottles included.)
It was classified as Class II, meaning exposure could trigger “temporary or medically reversible adverse health consequences,” per the FDA.
What is Duloxetine?
Duloxetine, reportedly known under brands like Cymbalta, Drizalma and Irenka, is used to treat mental health disorders like anxiety and depression, among other conditions, according to the Cleveland Clinic.
The Oct. 10 recall was of 7,107 duloxetine bottles distributed and manufactured by Towa Pharmaceutical Europe.
The Nov. 19 recall is of 233,003 duloxetine bottles distributed and manufactured by Rising Pharmaceuticals. Both recalls are Class II risks.
What should you do if your medication is recalled?
Officials urge those who may have medications with potential nitrosamine to stop taking them.
“Patients should talk to their health care professionals about concerns and other treatment options,” the FDA’s website says.
What are nitrosamines?
Nitrosamines are found in water, cured and grilled meats, dairy products and vegetables, according to the FDA. While nearly everyone is exposed to trace amounts of nitrosamines, studies link the contaminants to increased cancer risk if people are exposed to large amounts over long periods of time.
More than 12 million bottles of blood pressure-lowering drugs such as valsartan and losartan have been removed from the market since 2018 because they contained nitrosamines.
The same family of contaminants triggered past recalls of the heartburn drug Zantac, the diabetes drug metformin and the smoking cessation medication Chantix.
Contributing: Ken Alltucker
This article originally appeared on USA TODAY: Duloxetine recall: FDA expands recall to more than 233,000 bottles
