FDA Recalls More than 233,000 Bottles of Antidepressant over Possible Cancerous Chemical


December 17, 2024

An article published in USA Today on December 12th reports that more than 233,000 bottles of an antidepressant sold by a New Jersey based company, Rising Pharmaceuticals, have been recalled. The U.S. Food and Drug Administration (FDA) classified capsules of duloxetine as a Class II risk on December 5th.

The article adds, "The bottles contain the 'presence' of nitrosamine drug substance impurity, N-nitroso-duloxetine, that exceeds the recommended interim limit, according to the FDA. 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."

Duloxetine, reportedly known under brands such as Cymbalta, Drizalma and Irenka, is used to treat mental health disorders including anxiety and depression, among other conditions. Officials urge those who may have these medications to stop taking them and talk to their healthcare professionals about treatment options.

Read the article here.

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