What is duloxetine? What to know about recalled antidepressant
FDA recalls 7,000 bottles of possibly carcinogenic antidepressant
The Food and Drug Administration (FDA) has issued a Class II recall for over 7,000 bottles of duloxetine, a popular antidepressant, due to the presence of a potentially carcinogenic chemical.
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A popular antidepressant, often known by the brand name Cymbalta, was recalled last week due to the presence of a potentially cancer-causing chemical.
More than 233,000 bottles of duloxetine capsules sold by Rising Pharmaceuticals were voluntarily recalled on Nov. 19, and the U.S. Food and Drug Administration assigned the recall as a class II risk on Dec. 5. The risk level is the FDA’s second most severe level as it could cause “temporary or medically reversible adverse health consequences.”
According to the FDA, the medication had the “presence” of an impurity – a potentially cancer-causing substance, or nitrosamine – called N-nitrosoduloxetine, that exceeds the recommended limit. The increased presence of this chemical “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”
Wondering what all of this actually means and how it works? Here’s what to know.
What is duloxetine and how does it work?
Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is taken orally, most commonly as an antidepressant, often in an extended-release tablet form.
Duloxetine is also used to treat some forms of pain and works by increasing neurotransmitters in the brain.
The most common side effects include drowsiness, nausea, constipation, loss of appetite, dry mouth and increased sweating, according to Drugs.com.
What is an SNRI and how does it work?
An SNRI (serotonin and norepinephrine reuptake inhibitor) is one of two major classes of medications used to treat clinical symptoms of depression and anxiety, along with SSRIs (selective serotonin reuptake inhibitors), according to Cleveland Clinic.
Duloxetine is one of the most commonly used SNRIs in the U.S., often prescribed under the brand name Cymbalta. Duloxetine is also FDA-approved to help treat other conditions, including chronic musculoskeletal pain, generalized anxiety disorder (GAD), diabetes-related neuropathy pain and fibromyalgia.
Three other SNRIs are FDA-approved to treat major depressive disorder symptoms: Desvenlafaxine, Levomilnacipran and Venlafaxine.
SNRIs work by affecting specific neurotransmitters in the brain, which are chemical messages sent between brain cells responsible for functions like circadian rhythm, mood, memory, energy, attention appetite and more, according to the Cleveland Clinic.
As the name suggests, SNRIs work on two specific neurotransmitters: Serotonin and norepinephrine. Usually, neurotransmitters are reabsorbed by cells in your brain after they complete their task, known as reuptake. Sometimes, this can happen too much or too fast. SNRIs work by blocking this absorption or inhibiting it, allowing more serotonin and norepinephrine to remain active and available in the brain and transmit easier from nerve to nerve.
What is N-nitroso-duloxetine?
In layman’s terms, N-nitroso-duloxetine simply refers to a specific impurity that can be found in duloxetine. It is a type of nitrosamine specific to duloxetine and can be introduced via the manufacturing or storing process, Jamie Alan, PhD, an associate professor of pharmacology and toxicology at Michigan State University, told Health.com.
Too high a level of nitrosamine can damage human DNA and become carcinogenic.
What are nitrosamines?
Nitrosamines are compounds found in water, cured and grilled meats, dairy products and vegetables, according to the FDA. While nearly everyone is exposed to trace amounts of nitrosamines, studies link the contaminants to increased cancer risk if people are exposed to large amounts over long periods of time.
More than 12 million bottles of blood pressure-lowering drugs such as valsartan and losartan have been removed from the market since 2018 because they contained nitrosamines.
The same family of contaminants triggered past recalls of the heartburn drug Zantac, the diabetes drug metformin and the smoking cessation medication Chantix.
Who makes duloxetine drugs?
The recent recall covered duloxetine drugs made by New Jersey-based company Rising Pharmaceuticals, while an earlier recall in October concerned capsules made by Towa Pharmaceutical Europe.
The name brand, Cymbalta, is manufactured by Eli Lilly and Company, which launched the drug to the public in 2004 after FDA approval.
Contributing: Anthony Robledo, Taylor Ardrey, USA TODAY
https://www.usatoday.com/story/news/health/2024/12/13/what-is-duloxetine-recall-fda/76966326007/
