Posted on 12/16/2024 11:06:39 AM PST by Red Badger
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.1
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.
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."
Fwiw, the pharmacies I use both said if there’s a problem we’ll call you. Walgreens and king Soopers (Kroger)
It’s also commonly prescribed “off-label” for neuropathic pain.
“That can include irritability, nausea, dizziness, vomiting, nightmares, headache, and suicide ideations.”
And mass shootings.
Keep taking all those prescriptions folks.. they’re good for you.
LOL. I was prescribed this drug two days ago and wake up to this news as Im getting ready to pick up my prescription. I just went through a year of successful cancer treatment ...Now Im going to be killed by the drug Im taking to get me through the anxiety of dealing with all the crap left to handle after this crazy year. Can’t make this shit up!
Oh sure. Now the FDA is trying to justify their existence before any possible investigations. Where were they in 2020? What happened? Eli Lilly didn’t give enough bribes to the FDA?
Well, now I'm depressed.
There are lots of funny ways to spoof this, but drug purity should be one of the FDA’s primary focuses.
Good job government bureaucrats for doing something right for once.
Did you ever get the feeling that they are trying to kill us all?..............after they drain our bank accounts...........
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