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What Is Duloxetine Used For And What Are Its Side Effects? FDA Recalls More Than 7,000 Bottles

Earlier this week, the U.S. Food and Drug Administration (FDA) issued a major recall involving over 7,100 bottles of duloxetine, the generic equivalent of the well-known antidepressant Cymbalta.

The recall was prompted by the detection of N-nitroso-duloxetine, a chemical impurity classified as a nitrosamine, which could pose cancer risks with long-term exposure. As a result, the FDA categorized the recall as Class II, meaning it presents a moderate health risk. Duloxetine is commonly prescribed for depression, anxiety, and fibromyalgia, making this recall significant for many patients.

The affected batches include 20mg, 30mg, and 60mg delayed-release capsules manufactured by Towa Pharmaceutical Europe and distributed by Breckenridge Pharmaceutical. The specific lot under recall is Lot No. 220128, which has an expiration date of December 2024.

The FDA advises patients taking duloxetine to consult their healthcare providers to discuss potential risks and alternative treatments. Healthcare professionals and pharmacies have been instructed to stop distributing the affected lots and appropriately manage any remaining stock.

While patients are urged not to panic, they are encouraged to speak with their doctors to evaluate next steps. It remains important for healthcare providers and patients to stay updated on further guidance from the FDA as the situation unfolds

What Is Duloxetine?

Duloxetine is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) antidepressant, working to balance brain chemicals that may be off in individuals with depression.

It is primarily prescribed for treating major depressive disorder in adults, and is also used to manage generalized anxiety disorder in both adults and children aged 7 or older.

In addition to its mental health applications, duloxetine is prescribed to adults for nerve pain related to diabetes (diabetic neuropathy) and chronic muscle or joint pain, such as lower back pain or osteoarthritis. Certain brands of duloxetine, such as Drizalma, are specifically used to treat fibromyalgia in adults, while Cymbalta may be used for fibromyalgia in adults and children 13 and older.

This medication also helps alleviate nerve pain in diabetic patients or those suffering from chronic pain linked to conditions like arthritis, fibromyalgia, or persistent back pain. Belonging to the serotonin-norepinephrine reuptake inhibitor (SNRI) class, duloxetine works by helping restore the balance of serotonin and norepinephrine in the brain.

If you experience signs of an allergic reaction to duloxetine, such as hives, difficulty breathing, or facial or throat swelling, or a severe skin reaction like fever, sore throat, eye irritation, skin pain, or a rash with blistering and peeling, seek emergency medical attention immediately.

Notify your doctor if you experience sudden mood or behavioral changes, including worsening depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, aggressive, restless, overly energetic or talkative, or have thoughts of harming yourself or others.