Recall alert: FDA recalls more than 233K bottles of antidepressant duloxetine

More than 233,000 bottles of the antidepressant duloxetine have been recalled because of a chemical that contains the risk of cancer, public health officials said.

The U.S. Food and Drug Administration classified the capsules as a Class II risk on Dec. 5, USA Today reported. That is the second-highest level of severity as it can possibly cause “temporary or medically reversible adverse health consequences.”

The capsules are sold by Rising Pharmaceuticals, a company based in New Jersey, according to USA Today. The company did not immediately respond to the newspaper’s request for comment.

The FDA issued a voluntary recall of the company’s product on Nov. 19.

In three separate reports, the FDA said that various doses of duloxetine delayed-release capsules were recalled due to the “presence” of a nitrosamine drug substance impurity, N-nitroso-duloxetine, that exceeds the recommended interim limit.

Duloxetine is the generic version of drugs sold under the brand names Cymbalta and Irenka, according to Health.com. The drug is used to treat depression in adults and generalized anxiety disorder in adults and children over the age of 7, according to the website. It is also used to treat pain caused by fibromyalgia or nerve damage due to diabetes.

According to the FDA, 233,003 bottles were recalled on Nov. 19. This included delayed-release capsules in 30-count, 90-count and 1,000-count bottles, USA Today reported.

On Oct. 10, the FDA announced a Class II recall for 7,107 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe, according to the agency’s website.

David Cosio, a psychologist in the pain clinic and the interdisciplinary pain program at the Jesse Brown VA Medical Center in Chicago, spoke about the drug with Oncology News Central in an October interview.

“The chemicals found in duloxetine put patients at a higher risk of developing cancer when they are present in higher concentrations and when patients are exposed to them for an extended period of time,” Cosio said.

Cosio added that the recall should not disrupt treatment plans.

“There is no reason to stop prescribing duloxetine, as the benefits outweigh the risk posed by the impurity found in a specific lot of the product,” Cosio said in October. “Thousands of bottles have been recalled across the U.S. already by the FDA.”

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