More than 233,000 bottles of antidepressants have been recalled by public health authorities after they were found to contain chemicals that pose a cancer risk.
The U.S. Food and Drug Administration on Dec. 5 classified duloxetine capsules sold by New Jersey-based company Rising Pharmaceuticals as a Class II risk. Risk levels are FDA standards. second most severe level Because it can cause “temporary or medically reversible adverse health effects.”
The FDA said the bottle contained N-nitroso-duloxetine, a nitrosamine drug substance impurity, in excess of interim recommendations.
Rising Pharmaceuticals, which reported the FDA issued a voluntary recall on Nov. 19, did not immediately respond to USA TODAY’s request for comment.
New research: Ultra-processed foods can make you gain fat and weight regardless of exercise
The FDA states that impurities in nitrosamines areMay increase risk of cancer However, “people who have been taking drugs containing nitrosamines daily for 70 years below the acceptable daily intake have an increased risk of cancer if they take nitrosamines over a long period of time.”
In October, the FDA initially announced a Class II recall of just 7,107 duloxetine capsules sold by Towa Pharmaceutical Europe.
Looking for more recalls? Check out USA TODAY’s recall database
How many bottles of Duloxetine have been recalled?
According to the FDA, 233,003 bottles were recalled (including 30-count, 90-count, and 1000-count delayed-release capsule bottles).
It is classified as Class II, meaning it can be induced by exposure. “temporary or medically reversible adverse health effects” According to the FDA.
What is duloxetine?
Duloxetine, known by brands such as Cymbalta, Drizalma, and Ylenka, is used for: treat mental health disorders According to the Cleveland Clinic, this includes conditions such as anxiety and depression.
The October 10 recall affected 7,107 bottles of duloxetine sold and manufactured by Towa Pharmaceutical Europe.
The Nov. 19 recall affected 233,003 bottles of duloxetine sold and manufactured by Rising Pharmaceuticals. Both recalls are Class II risks.
What should I do if the medicine I’m taking is recalled?
Authorities are urging people who may be taking medications that may contain nitrosamines to stop taking them.
“Patients should consult their health care professional about any concerns or other treatment options,” the FDA website states.
What are nitrosamines?
According to the FDA, nitrosamines are found in water, cured and grilled meats, dairy products, and vegetables. Although nearly everyone is exposed to trace amounts of nitrosamines, studies have linked the contaminants to an increased risk of cancer when people are exposed to large amounts over long periods of time.
More than 12 million bottles of blood pressure medications such as valsartan and losartan have been removed from the market since 2018 because they contained nitrosamines.
The same kind of contaminants caused a recall of the heartburn and diabetes drug Zantac in the past. metformin and smoking cessation medication chantix.
Contributor: Ken Alltucker
This article originally appeared on USA TODAY. Duloxetine recall: FDA expands recall to more than 233,000 bottles
