What is Duloxetine? What you should know about recalled antidepressants

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 November 19, and the U.S. Food and Drug Administration classified the recall as a Class II risk on December 5. The risk level is the FDA’s second most serious level and it could cause “temporary or medically reversible adverse health effects.”

According to the FDA, the drug had the “presence” of an impurity – a potentially carcinogenic substance or nitrosamine – called N-nitrosoduloxetine, which exceeded the recommended limit. The increased abundance of this chemical “may increase the risk of cancer when people are exposed to it above acceptable levels and for long periods of time.”

Are you wondering what it all actually means and how it works? Here’s what you should know.

Retrieve:The FDA is recalling more than 233,000 bottles of antidepressants because of a possible cancer-causing chemical

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 the form of an extended-release tablet.

Duloxetine is also used to treat some forms of pain and works by increasing neurotransmitters in the brain.

According to Drugs.com, the most common side effects include drowsiness, nausea, constipation, loss of appetite, dry mouth, and increased sweating.

What is an SNRI and how does it work?

According to the Cleveland Clinic, an SNRI (serotonin and norepinephrine reuptake inhibitors) is one of two main classes of medications used to treat clinical symptoms of depression and anxiety, along with SSRIs (selective serotonin reuptake inhibitors).

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 FDA-approved to treat other conditions, including chronic musculoskeletal pain, generalized anxiety disorder (GAD), diabetes-related neuropathy pain, and fibromyalgia.

Three other SNRIs are approved by the FDA to treat symptoms of major depressive disorder: desvenlafaxine, levomilnacipran, and venlafaxine.

According to the Cleveland Clinic, SNRIs work by affecting certain neurotransmitters in the brain. These are chemical messages sent between brain cells and are responsible for functions such as circadian rhythms, mood, memory, energy, attentional appetite, and more.

As the name suggests, SNRIs act on two specific neurotransmitters: serotonin and norepinephrine. Normally, neurotransmitters are reuptaken by cells in your brain after they have completed their job, which is called reuptake. Sometimes this can happen too often or too quickly. SNRIs work by blocking or inhibiting this absorption, allowing more serotonin and norepinephrine to remain active and available in the brain and to be transmitted more easily from nerve to nerve.

What is N-Nitroso-Duloxetine?

In layman’s terms, N-nitroso-duloxetine simply refers to a specific impurity found in duloxetine. It is a type of nitrosamine that is specific to duloxetine and can be introduced through the manufacturing or storage process, Jamie Alan, PhD, associate professor of pharmacology and toxicology at Michigan State University, told Health.com.

Excessive levels of nitrosamine can damage human DNA and become carcinogenic.

What are Nitrosamines?

According to the FDA, nitrosamines are compounds found in water, sausage and grilled meat, dairy products and vegetables. While almost everyone is exposed to trace amounts of nitrosamines, studies link the pollutants to an increased risk of cancer when people are exposed to large amounts over a long period 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 has previously triggered recalls of the heartburn drug Zantac, the diabetes drug Metformin and the smoking cessation drug Chantix.

Who makes Duloxetine medication?

The most recent recall involved duloxetine medication made by New Jersey-based Rising Pharmaceuticals, while an earlier recall in October involved capsules manufactured by Towa Pharmaceutical Europe.

The brand name Cymbalta is manufactured by Eli Lilly and Company, which launched the drug in 2004 after FDA approval.

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What is Duloxetine? What you should know about recalled antidepressants

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