Certain bottles and doses of duloxetine, a common antidepressant, have been recalled due to the presence of potentially cancer-causing chemicals

Duloxetine Recall: FDA Sets Second-Highest Risk Level for Antidepressants Containing Potential Carcinogen The recall was initiated on Nov. 19 by manufacturer Rising Pharma, Inc. and was set as a "class II" risk level by the FDA on Dec. 5

Certain bottles and doses of duloxetine, a common antidepressant, have been recalled due to the presence of potentially cancer-causing chemicals

• Certain bottles and doses of duloxetine, a common antidepressant, have been recalled due to the presence of potentially cancer-causing chemicals.
• The recall was initiated on Nov. 19 by manufacturer Rising Pharma, Inc. and was set as a "class II" risk level by the FDA on Dec. 5.
• The medication was recalled due to the "presence of N-nitroso-duloxetine impurity above [the] recommended interim limit," the FDA said.

Another commonly prescribed antidepressant medication has been recalled due to the presence of potentially cancer-causing chemicals, according to the Food and Drug Administration.

On Nov. 19, various doses of duloxetine delayed-release capsules manufactured by Rising Pharma, Inc., were recalled due to the "presence of N-nitroso-duloxetine impurity above [the] recommended interim limit," the FDA said in three separate enforcement reports.

Overall, more than 550,000 bottles of duloxetine were involved in the recall. The voluntarily recalled drugs were given a "class II" risk level by the FDA on Dec. 5, the second most severe FDA recall status.

Duloxetine—the generic version of drugs sold under the brand names Cymbalta and Irenka—is used to treat depression in adults and generalized anxiety disorder in adults and children over the age of 7. The drug is also used to treat pain from fibromyalgia or nerve damage due to diabetes.

Here's what you need to know about the recalled medication and its FDA risk classification.

What Is a 'Class II' Recall?

A class II recall is the FDA’s second most serious recall status. It’s given to a product when its use “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Which Products Were Recalled?

The new duloxetine recall affects various doses and bottles of the medication. See below for the exact products recalled:

Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles

• Lot numbers DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, with an expiration date of Nov. 2024
• Lot numbers DT2023001B, DT2023004A, DT2023005A, DT2023006A, with an expiration date of Jan. 2025

Duloxetine Delayed-Release Capsules USP, 30 mg, 30 count bottles

• Lot number DT3023019A, with an expiration date of Jan. 2025
• Lot number DT3023050A, with an expiration date of Apr. 2025

Duloxetine Delayed-Release Capsules USP, 30 mg, 90 count bottles

• Lot number DT3023022A, with an expiration date of Jan. 2025

Duloxetine Delayed-Release Capsules USP, 30 mg, 1,000 count bottles

• Lot numbers DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, with an expiration date of Nov. 2024
• Lot numbers DT3023001A, DT3023003A, with an expiration date of Dec. 2024
• Lot numbers DT3023024A, DT3023020B, with an expiration date of Jan. 2025
• Lot numbers DT3023027A, DT3023028A, with an expiration date of Feb. 2025
• Lot number DT3023034A, with an expiration date of Mar. 2025
• Lot number DT3023049A, with an expiration date of Apr. 2025
• Lot number DT3023095A, with an expiration date of Jul. 2025

Duloxetine Delayed-Release Capsules USP, 60 mg, 30 count bottles

• Lot numbers DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, with an expiration date of Jan. 2025
• Lot number DT6023080A, with an expiration date of Feb. 2025
• Lot number DT6023093A, with an expiration date of Mar. 2025
• Lot number DTC24012A, with an expiration date of Dec. 2025

Duloxetine Delayed-Release Capsules USP, 60 mg, 90 count bottles

• Lot number DT6023108A, with an expiration date of Apr. 2025
• Lot number DTC23201A, with an expiration date of Aug. 2025

Duloxetine Delayed-Release Capsules USP, 60 mg, 1,000 count bottles

• Lot numbers DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, with an expiration date of Nov. 2024
• Lot numbers DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, with an expiration date of Dec. 2024
• Lot number DT6023067C, with an expiration date of Jan. 2025
• Lot number DT6023114A, with an expiration date of Apr. 2025
• Lot number DTC23243A, with an expiration date of Oct. 2025
• Lot number DTC24040A, with an expiration date of Dec. 2025
  

Why Was the Medication Recalled?

According to the FDA enforcement reports, the drugs were recalled due to the "presence of N-nitroso-duloxetine impurity above [the] recommended interim limit."

N-nitroso-duloxetine is an impurity found in duloxetine, likely introduced during the manufacturing or storing process, according to Jamie Alan, PhD, an associate professor of pharmacology and toxicology at Michigan State University.

N-nitroso-duloxetine is a type of nitrosamine specific to duloxetine. Nitrosamines are compounds that can damage DNA and may cause cancer in humans "especially when people are exposed to the chemicals in high doses or for extended periods of time," Kelly Johnson-Arbor, MD, a toxicologist at MedStar Health, told Health. 

Since duloxetine is used to treat anxiety, depression, chronic pain, and other long-term conditions, people who take duloxetine over lengthy periods of time may build up higher-than-expected levels of the N-nitroso-duloxetine impurity in their bodies, which in turn may increase their risk of experiencing harmful health effects, Johnson-Arbor explained.

This isn't the first time duloxetine has been recalled due to the presence of N-nitroso-duloxetine impurities. In October, more than 7,000 bottles of 500-count 20 mg duloxetine delayed-release capsules produced by Towa Pharmaceutical Europe were also recalled over the potential presence of N-nitroso-duloxetine;

What to Do If You Have the Recalled Medication

Not all formulations of duloxetine are part of the current recall, said Johnson-Arbor noted that not all formulations of duloxetine are part of the current recall. If you take duloxetine, it’s important to carefully read the label and the recall notice to see if your medication is impacted.

If you’re unsure, you can contact your pharmacist for more information.

“If people learn that their prescription was part of the recall, they should initially contact their doctor or pharmacy to ask about whether there are alternative treatments, such as different formulations of duloxetine, that they can take instead of the recalled medication,” Johnson-Arbor said.

But it’s important to not take yourself off the medication without talking to a doctor first.

“Withdrawal from this type of medication, whether used for depression or neuropathic pain or something else, can be challenging,” Alan said. That can include irritability, nausea, dizziness, vomiting, nightmares, headache, and suicide ideations.

“Be sure to speak to your healthcare provider," Alan said, "to appropriately taper this medication."

This story originally appeared on: Health News - Author:Korin Miller