The popular antidepressant drug, better known by its brand name Cymbalta, was recalled last week because it contains a chemical that can cause cancer.
More than 233,000 bottles of duloxetine capsules sold by Rising Pharmaceuticals were voluntarily recalled on November 19th, and the U.S. Food and Drug Administration designated the recall as a Class II risk on December 5th. Risk levels are FDA standards. second most severe level Because it can cause “temporary or medically reversible adverse health effects.”
The drug had an impurity called N-nitrosoduloxetine, a carcinogen and nitrosamine, “present” above recommended limits, the FDA said. As the presence of this chemical increases,May increase risk of cancer If people are exposed to them for an extended period of time above acceptable levels. ”
Wondering what this actually means and how it works? Here’s what you need to know.
Recall: FDA recalls more than 233,000 antidepressants due to possible cancer-causing chemicals
What is duloxetine and how does it work?
duloxetine Serotonin and norepinephrine reuptake inhibitors (SNRIs). It is most commonly taken orally as an antidepressant, often in the form of extended-release tablets.
Duloxetine is also used to treat some types of pain and works by increasing neurotransmitters in the brain.
The most common side effects include drowsiness, nausea, constipationAccording to Loss of Appetite, Dry Mouth, and Increased Sweating. medicine.com.
What are SNRIs and how do they work?
According to This is one of the. cleveland clinic.
Duloxetine is one of the most commonly used SNRIs in the United States and is often prescribed under the brand name Cymbalta. Duloxetine is also approved by the FDA to treat other conditions such as chronic musculoskeletal pain, generalized anxiety disorder (GAD), diabetes-related neuropathic pain, and fibromyalgia.
Three other SNRIs, desvenlafaxine, levomilnacipran, and venlafaxine, are FDA-approved to treat symptoms of major depressive disorder.
According to the Cleveland Clinic, SNRIs work by affecting specific neurotransmitters in the brain. Neurotransmitters are chemical messages sent between brain cells that are responsible for functions such as circadian rhythms, mood, memory, energy, and attention.
As the name suggests, SNRIs act on two specific neurotransmitters: serotonin and norepinephrine. Normally, neurotransmitters are reabsorbed by cells in the brain after completing a task known as reuptake. In some cases, this may be too much or too fast. SNRIs work by blocking or inhibiting this absorption, allowing more serotonin and norepinephrine to remain active and available in the brain, facilitating nerve-to-nerve transmission.
Duloxetine is a drug primarily used for major depressive disorder, generalized anxiety disorder, fibromyalgia, and neuropathic pain.
What is N-nitroso-duloxetine?
In layman’s terms, N-nitroso-duloxetine simply refers to certain impurities present in duloxetine. This is a type of nitrosamine that is unique to duloxetine and can enter through the manufacturing or storage process, said Dr. Jamie Allan, associate professor of pharmacology and toxicology at Michigan State University. states. told Health.com.
Too high levels of nitrosamines can damage human DNA and cause cancer.
What are nitrosamines?
According to the FDA, nitrosamines are compounds 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.
Who manufactures the drug Duloxetine?
The most recent recall involved duloxetine drugs made by New Jersey-based Rising Pharmaceuticals, while an earlier recall in October involved capsules made by Towa Pharmaceutical Europe. was.
The well-known brand Cymbalta is manufactured by Eli Lilly, which released the drug to the public in 2004 after FDA approval.
contribution: Anthony Robredo, taylor ardleytoday’s America
This article originally appeared on USA TODAY. What is duloxetine? What you need to know about the recalled antidepressant
