FDA marks Cymbalta generic for chemical product

The US Food and Drug Administration one announced Class II recall for more than 7,100 bottles Duloxetine – a generic antidepressant for Cymbalta – due to a carcinogenic chemical.

A voluntary memory was initiated on October 10 by Breckenridge Pharmaceutical Inc.

Duloxetine is used to it treat mental disorders such as anxiety and depressionunder other conditions, according to the Cleveland Clinic. The product was distributed nationwide and manufactured by Pharmaceutical Towa Europe.

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Here’s what we know about the Duloxetine recall:

What is Duloxetine?

Duloxetine is used for treatment depression in adults and generalized anxiety disorder in adults and children 7 years and older, according to medlineplus.gov.

Is Duloxetine the generic antidepressant for Cymbalta?

Yes, duloxetine is the generic antidepressant for Cymbalta, according to my.clevelandclinic.org.

Is there a 2024 FDA recall on Duloxetine antidepressants?

Yes, the FDA noted that the drug had the “presence” of nitrosamine impurity of the drug substance, N-nitroso-duloxetine.

According to the FDA, Nitrosamine Impurities”can increase the risk of cancer when people are exposed above acceptable levels and for long periods.”

Which batch of the antidepressant Duloxetine is being recalled?

According to the FDA, the recalled lot was #220128 and expires in December 2024.

What should you do if your medication is recalled?

Officials are urging those who may be on medications with possible nitrosamine to stop taking them.

“Patients should talk to their healthcare providers about concerns and other treatment options,” the FDA website says.

What are nitrosamines?

Nitrosamines are found in water, salted and grilled meats, dairy products and vegetables, according to the FDA.

Do nitrosamine chemicals cause cancer?

According to the FDA, nitrosamine impurities can increase the risk of cancer if people are exposed to them above acceptable levels for extended periods of time. Someone who takes a drug containing nitrosamines every day for 70 years at – or below – acceptable daily intake limits would not be expected to have an increased risk of cancer.

What are the side effects of the antidepressant Duloxetine?

Here is a list of side effects of Duloxetine that you should report to your doctor or healthcare team as soon as possible. They include:

Allergic reactions – rash, itching, hives, swelling of the face, lips, tongue or throat
Bleeding – bloody or black, tarry stools, red or dark brown urine, vomiting blood or brown material that looks like coffee grounds, small, red or purple spots on the skin, unusual bleeding or bruising
Increase in blood pressure
Liver damage–pain in the upper right abdomen, loss of appetite, nausea, light-colored stools, dark yellow or brown urine, yellowing of the skin or eyes, unusual weakness or fatigue
Low sodium – muscle weakness, fatigue, dizziness, headache, confusion
Redness, blistering, peeling or loosening of the skin, including in the mouth
Serotonin syndrome – irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching, sweating, high fever, seizures, chills, vomiting, diarrhea
Sudden eye pain or change in vision, such as blurred vision, seeing halos around lights, vision loss
Thoughts of suicide or self-harm, deterioration of mood, feelings of depression
Problems with urination

Here is a list of side effects that usually do not require medical attention. If the symptoms persist or are bothersome, you should report this to your doctor or healthcare team. They include:

Change in sex drive or performance
Constipation
Diarrhea
Dizziness
Dry mouth
Excessive sweating
Loss of appetite
Nausea
Vomiting

National Drug Take Back Day 2024 is October 26

For anyone wondering how to dispose of medicationsThe US Drug Enforcement Administration (DEA) sponsor National take-back day for prescription medicines in communities across the country. Visit www.dea.gov/takebackday to find a collection point near you.

You can also contact your local pharmacist. Some pharmacies offer on-site medication drop boxes, mail-back programs, and other ways to help you safely dispose of your unused medications.

Chris Sims is a digital content producer at Midwest Connect Gannett. Follow him on Twitter: @ChrisFSims.