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Public health officials said more than 233,000 bottles of an antidepressant have been recalled due to a chemical that contains the risk of cancer.
The U.S. Food and Drug Administration (FDA) classified capsules of duloxetine as a Class II risk on Dec. 5, USA TODAY reports.
New Jersey-based company Rising Pharmaceuticals sells the product.
More than 233,000 bottles of duloxetine, an antidepressant, recalled The FDA has classified both duloxetine recalls as Class II — its second-most severe recall level, https://t.co/QwdedVTfXi
— Beverley Thomson (@Antidepressed1) December 14, 2024
Per USA TODAY:
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.
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.”
What is duloxetine and how does it work? What to know about antidepressant recalled by FDA https://t.co/47yfC0n7Ey
— USA TODAY (@USATODAY) December 14, 2024
The FDA announced a Class II recall for approximately 7,000 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe in October.
USA TODAY noted that duloxetine is reportedly sold under brand names such as Cymbalta, Drizalma and Irenka.
🚨FDA RECALLS 7,000 BOTTLES OF ANTIDEPRESSANT CYMBALTA OVER CANCER RISK
The FDA has recalled over 7,000 bottles of Cymbalta after detecting elevated levels of N-nitroso-duloxetine, a cancer-linked chemical.
Initiated on October 10, this Class II recall involves bottles with… pic.twitter.com/orz9tpolTE
— Mario Nawfal (@MarioNawfal) October 31, 2024
WSB-TV reports:
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.”