The U.S. Food and Drug Administration has recalled thousands of bottles of the antidepressant drug Duloxetine because of potentially cancer-causing chemicals above the acceptable limit set by the FDA, according to an Oct. 11 report from the federal agency. The drug is sold under the brand name Cymbalta.
A voluntary recall of duloxetine delayed-release capsules began on October 10 after the FDA deemed the drug the second-highest risk classification. More than 7,100 bottles of duloxetine were recalled, including 500 20 mg delayed-release capsules. The lot number is 220128 and the expiration date is 12/2024, according to the FDA report.
It’s a Class II recall, meaning the drug could cause “temporary or medically reversible adverse health effects,” according to the FDA.
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The drug, made by Towa Pharmaceutical Europe, is used to treat depression, anxiety and nerve pain, such as fibromyalgia or arthritis, according to WebMD.
The drug works by increasing levels of mood-elevating chemicals in the brain, and then N-nitroso-duloxetine chemicals can also be created at the same time, according to Newsweek.
The latter chemical is part of the nitrosamine group of chemicals, commonly found in water and food products. There could be a risk of developing cancer if it is found in higher concentrations and if people are exposed to it for a long time, so the FDA has strict limits on its concentrations.
Duloxetine vials.
Dhiraj Singh/Bloomberg via Getty
“There are a number of reasons why nitrosamines can be present in drugs. The FDA has found that the source of nitrosamines can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged,” the FDA said in a statement. , trans Newsweek. “As foods and drugs are processed in the body, nitrosamines can also form. FDA continues to test and investigate possible sources of drugs found to contain nitrosamines.”
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“Patients taking prescription drugs with potential nitrosamine impurities should not stop taking their medications,” the FDA added. “Patients should talk to their healthcare providers about problems and other treatment options.”
“The agency is working to determine the source of these impurities and will notify the public,” the federal agency said.
Categories: Trends
Source: HIS Education