Health and Me

Rachel V Thomas

Taking Duloxetine? US FDA Warns of Cancer-Causing Impurity in Antidepressant

Duloxetine, a widely prescribed antidepressant, has been recalled in the United States after the US Food and Drug Administration (FDA) found potentially cancer-causing impurities above federal safety limits.

According to the Cleveland Clinic, duloxetine is commonly used to treat depression, anxiety, fibromyalgia, and certain chronic pain conditions.

The FDA issued a notice stating the presence of N-nitroso-duloxetine, a nitrosamine impurity detected at levels exceeding the agency's recommended safety threshold. The recall affects nearly 370,000 bottles of prescription-only duloxetine delayed-release capsules USP, 30mg, 1000 Capsule bottles, distributed across the US.

The agency warned that exposure to nitrosamine impurities "may increase the risk of <a href="https://www.healthandme.com/health-wellness/vanessa-trump-begins-second-stage-of-breast-cancer-treatment-article-154643950" data-type="tilCustomLink">cancer </a> if people are exposed to them above acceptable levels and over long periods of time."

The agency classified the action as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, while the likelihood of serious health effects remains low.

<h2>How Is Duloxetine Linked to Cancer?</h2>

Also read: <a href="https://www.healthandme.com/health-news/us-fda-approves-first-new-sunscreen-ingredient-since-the-1990s-article-154558763" data-type="tilCustomLink">US FDA Approves First New Sunscreen Ingredient Since the 1990s</a>

Notably, this is the second duloxetine recall linked to the same impurity. In October 2024, more than 7,000 bottles were recalled because of potential nitrosamine contamination.

According to the FDA, people who take medications containing nitrosamines—even daily for up to 70 years—are not expected to face an increased cancer risk if nitrosamine levels remain at or below the recommended limits.

There is currently no direct evidence linking N-nitroso-duloxetine itself to cancer. However, it belongs to a class of compounds known as nitrosamines, some of which are considered probable human carcinogens.

Moreover, health risks associated with nitrosamines generally depend on both the amount and duration of exposure. Higher levels over extended periods are considered more concerning.

The US National Library of Medicine describes N-nitroso-duloxetine as a compound that is "suspected of causing cancer" and notes that it is toxic if swallowed.

At the same time, the California State Board of Pharmacy emphasizes that exposure does not automatically result in cancer. The agency notes that nitrosamines are commonly found in water and foods, including cured and grilled meats, dairy products, and vegetables.

"Everyone is exposed to some level of nitrosamines," the board states. "These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time."

Read More: <a href="https://www.healthandme.com/health-news/new-pancreatic-cancer-drug-daxaronrasib-may-benefit-patients-with-lung-and-ovarian-tumors-too-article-154439036" data-type="tilCustomLink">New Pancreatic Cancer Drug Daxaronrasib May Benefit Patients With Lung And Ovarian Tumors Too</a>

Antidepressants are prescription medications used to treat depression, anxiety disorders, chronic pain, and other conditions by increasing levels of certain brain chemicals involved in mood regulation.

Common classes of antidepressants include:

<ul><li>Selective serotonin reuptake inhibitors (SSRIs)</li><li>Serotonin-norepinephrine reuptake inhibitors (SNRIs)</li><li>Norepinephrine-dopamine reuptake inhibitors (NDRIs)</li></ul>

These medications often take several weeks to achieve their full therapeutic effect. Common side effects may include dry mouth, dizziness, nausea, and weight changes. Emerging research also suggests that side effects can vary significantly depending on the specific medication.

Duloxetine belongs to a class of antidepressants known as SNRIs.

Cleveland Clinic explained that duloxetine is used to treat depression, generalized anxiety disorder, fibromyalgia, and certain types of chronic pain, including nerve, bone, and joint pain.

The medication works by increasing levels of serotonin and norepinephrine in the brain—neurotransmitters that help regulate mood and pain perception.

Health Conditions A-Z

health

taking-duloxetine-us-fda-warns-of-cancer-causing-impurity-in-antidepressant

Duloxetine

FDA recall

Cancer risk in duloxetine

Antidepressant

us food and drug administration

snris

ebola-outbreak-could-last-over-a-year-warns-red-cross-as-death-toll-nears-200

Ebola Outbreak Could Last Over A Year, Warns Red Cross As Death Toll Nears 200

heatwaves-ozone-pollution-driving-heart-and-lung-disease-deaths-in-india-iit-study

Heatwaves, Ozone Pollution Driving Heart And Lung Disease Deaths In India: IIT Study

Health News

8 Sit-Up Variations to Strengthen Your Core and Build Stability

Benefits Of Ayurvedic Health Supplement Ashwagandha

9 Anti-Inflammatory Breakfast Options You Should Try

5 Foods You Should Avoid For PCOS, Says Gynecologist

Love Sitting With Your Legs Crossed? Here’s You Should Avoid It

6 Daily Foods That Are Secretly Increasing Your Calories

9 Brain Boosters You Should Do Everyday

Hip Exercises That Will Keep You Flexible As You Age

9 Leg Exercises Office Workers’ Should Do At Home

Benefits of Having Herbal Tea Every Morning

9 Daily Habits That Boost Your Brain Power

Lower-Body Exercises That Are Game-Changers

How Drinking Apple Cider Vinegar Helps You

Aging Myths You Should Never Believe

Superfoods That Support Your Gut Health

What Happens To Your Body When You Eat Instant Noodles Every Day?

Health Issues Premature Babies Often Face

Exercises Office Workers Should Do For Their Heart Health

Reasons Why You Should Add Raw Turmeric To Your Diet

Benefits Of Drinking Milk At Night: Why You Should Do It

Food That Provides Vitamin B12 Naturally In Your Diet

Surprising Health Benefits Of Fenugreek Seeds

9 Superfoods You Should Eat For Your Brain Health

What Does Mental Health Support Look Like At Work?

Long Stretches You Should Do To Unwind From Your Day

Colon Cancer In Young Adults: Early Symptoms You Should Know

Health Benefits Of Eating Dry Fruits Everyday

Are You At Risk For Fried Rice Syndrome?

These Tests Reveal How Well You Are Aging

Lower-Back Exercises You Should Do After A Long-Day's Work

Children’s Diet – What Kids Need To Eat For Immunity Building

Common Diabetes Myths That Could Hurt Your Health

Love Spicy Food? Here’s How It Affects Your Health

Superfood List: Veggies And Fruits You Must Have For Immunity

Foods People With IBS Should Avoid

Exercises To Improve Digestion

Easy Work Lunches You Can Make In The Morning

Hunger Vs Craving: Difference Explained In 60 seconds

These Things Can Cause Your Heart To Age Faster

High Carb Foods That Are Actually Healthy

Duloxetine, a widely prescribed antidepressant, has been recalled in the United States after the US Food and Drug Administration (FDA) found potentially cancer-causing impurities above federal safety limits.According to the Cleveland Clinic, duloxetine is commonly used to treat depression, anxiety, fibromyalgia, and certain chronic pain conditions.The FDA issued a notice stating the presence of N-nitroso-duloxetine, a nitrosamine impurity detected at levels exceeding the agency's recommended safety threshold. The recall affects nearly 370,000 bottles of prescription-only duloxetine delayed-release capsules USP, 30mg, 1000 Capsule bottles, distributed across the US.The agency warned that exposure to nitrosamine impurities "may increase the risk of cancer  if people are exposed to them above acceptable levels and over long periods of time."The agency classified the action as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, while the likelihood of serious health effects remains low.How Is Duloxetine Linked to Cancer?Also read: US FDA Approves First New Sunscreen Ingredient Since the 1990sNotably, this is the second duloxetine recall linked to the same impurity. In October 2024, more than 7,000 bottles were recalled because of potential nitrosamine contamination.According to the FDA, people who take medications containing nitrosamines—even daily for up to 70 years—are not expected to face an increased cancer risk if nitrosamine levels remain at or below the recommended limits.There is currently no direct evidence linking N-nitroso-duloxetine itself to cancer. However, it belongs to a class of compounds known as nitrosamines, some of which are considered probable human carcinogens.Moreover, health risks associated with nitrosamines generally depend on both the amount and duration of exposure. Higher levels over extended periods are considered more concerning.The US National Library of Medicine describes N-nitroso-duloxetine as a compound that is "suspected of causing cancer" and notes that it is toxic if swallowed.At the same time, the California State Board of Pharmacy emphasizes that exposure does not automatically result in cancer. The agency notes that nitrosamines are commonly found in water and foods, including cured and grilled meats, dairy products, and vegetables."Everyone is exposed to some level of nitrosamines," the board states. "These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time."What Are Antidepressants?Read More: New Pancreatic Cancer Drug Daxaronrasib May Benefit Patients With Lung And Ovarian Tumors TooAntidepressants are prescription medications used to treat depression, anxiety disorders, chronic pain, and other conditions by increasing levels of certain brain chemicals involved in mood regulation.Common classes of antidepressants include:Selective serotonin reuptake inhibitors (SSRIs)Serotonin-norepinephrine reuptake inhibitors (SNRIs)Norepinephrine-dopamine reuptake inhibitors (NDRIs)These medications often take several weeks to achieve their full therapeutic effect. Common side effects may include dry mouth, dizziness, nausea, and weight changes. Emerging research also suggests that side effects can vary significantly depending on the specific medication.What Is Duloxetine?Duloxetine belongs to a class of antidepressants known as SNRIs.Cleveland Clinic explained that duloxetine is used to treat depression, generalized anxiety disorder, fibromyalgia, and certain types of chronic pain, including nerve, bone, and joint pain.The medication works by increasing levels of serotonin and norepinephrine in the brain—neurotransmitters that help regulate mood and pain perception.

taking duloxetine? us fda warns of cancer-causing impurity in antidepressant

About Us

Contact Us

Terms & Conditions

Privacy Policy

Company

Health and Me is a premium website with content written and curated to function as a handbook for all Health concerns.

Taking Duloxetine? US FDA Warns of Cancer-Causing Impurity in Antidepressant

Ebola Outbreak Could Last Over A Year, Warns Red Cross As Death Toll Nears 200

Kerala Shigella Outbreak Hits 70 Cases, 4 Deaths In June: Why The Superbug Is Rising

India Ends OTC Sale of Cough Syrups, Doctor's Prescription Now Mandatory

Health Conditions A-Z

Taking Duloxetine? US FDA Warns of Cancer-Causing Impurity in Antidepressant

Ebola Outbreak Could Last Over A Year, Warns Red Cross As Death Toll Nears 200

Heatwaves, Ozone Pollution Driving Heart And Lung Disease Deaths In India: IIT Study