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The U.S. Food and Drug Administration (FDA) has recently announced a Class 2 recall involving 700 bottles of Duloxetine, a commonly prescribed medication used to treat conditions such as depression, anxiety, and nerve pain. This FDA recalls Duloxetine because immense concerns were raised about potential safety issues with specific batches. In this blog, we’ll discuss the details of the recall, what a Class 2 recall means, and the steps affected patients and healthcare providers should take.

Why Has the FDA Announced A Class II Recall of 700 Bottles of Duloxetine?

On October 10th, the Food and Drug Administration announced a Class II recall of 700 bottles carrying Duloxetine due to the excessive amounts of impurities of N-nitroso- duloxetine drug that is considered to be a cancer-causing chemical. The FDA and other food and drug regulatory bodies around the world have set international standards regarding the usage of this drug, stating that it should not be over 600 ng/day. 

Over here, the manufacturers and distributors, who were none other than Towa Pharmaceutical Company Europe, heavily violated the rules by adding 20 Mg. Therefore, the FDA took this action, offering them another opportunity to improve the medicine so that it becomes safe for consumption. On the other hand, the pharmaceutical company discussed the recall with Health and said that they are collaborating and working with the FDA and other related authorities to implement the decision. Their team is working on those anti-depressants as they are not in favor of compromising patient safety. Hence, people need to give them some time before Duloxetine shows up again in the market. 

What Is Class II Recall? 

Since it is a Class II recall, let us clarify your concept related to this classification. It is defined as a situation where if an individual tends to use medicine more than the prescribed limit, then that can lead to temporary negative health conditions, and they have narrow chances of recovery.

Duloxetine and Its Purpose 

We are sure you must be wondering what Duloxetine is. It is an antidepressant whose brand name is Cymbalta, which individuals suffering from depression consume to cure their anxiety and depression. However, the Mayo Clinic shares that the same medicine can also be taken to reduce pain caused by the damage of nerves linked with diabetes. 

FDA recalls Duloxetine: Why?

The primary reason why FDA recalls Duloxetine is that the medication which is supposed to treat patients suffering from depression or anxiety, have been found with extra amounts of Nitrosamine.

What Is Nitrosamine? 

For individuals who are hearing about nitrosamine for the first time, let us inform you that these are chemical compounds, and some of them are carcinogenic, too. When nitrites and secondary amines react together, you get Nitrosamine. They are present in many products, such as cosmetics, rubber, processed meats, and pharmaceuticals as well. A toxicologist at MedStar Health, Kelly Johnson Arbor, MD, shared with Health that Nitrosamines are chemicals found in a variety of foods, the water you drink, cosmetics individuals use, and tobacco products. 

Why does a Nitrosamine raise concerns? It is because they get formed during food preservation or processing, particularly when one of the formation compound, nitrite, are used to stop the growth of bacteria from spoiling canned foods. Apart from that, if you grill or fry at high temperatures, then that even supports their creation. 

Nitrosamine: Life-Saver Or A Red Flag? 

Nitrosamine stands out as a red flag because when the substance enters the human body, they have a high tendency to cause cancers. They can cause liver, stomach, and esophagus cancer that can adversely affect the DNA. Observing their negative consequences, reliable and prominent drug regulatory bodies, including the FDA, have set specific limits and insisted that pharmaceutical companies follow the same while making medicines. In the food industry also, they insisted the makers reduce the usage of Nitrosamines in processed meats and requested the public to switch to select fresh and other substitutes with minimum processing. 

The toxicologist agreed that Nitrosamine causes cancer in humans. He said that not all nitrosamines cause harmful health conditions, but when a human being is exposed to other nitrosamine compounds, things become troublesome. The chance of being diagnosed with Cancer elevates when individuals consume these compounds in the form of heavy doses, and that too for a long period of knowing. Many of them don’t even know what is happening, and the chemical spreads the disease to their liver, stomach, and esophagus. 

Even the FDA says that on being exposed to Nitrosamine impurities for a long period of time, or way above the recommended intake, then the risk of getting diagnosed with Cancer simply increases in people. But, it also puts forward another insight that if an individual takes a drug containing Nitrosamines according to the prescribed dosage or limits their daily use for 70 years, they are not at risk of becoming a Cancer patient. 

How Many Cases Came Into the Limelight? 

You might not believe it, but several cases regarding nitrosamine have come into the limelight. In the past, many medicines were reported to contain this chemical. What was the outcome of the discovery? It was the same as what Towa Pharmaceutical Europe is facing, of recalls and soaring levels of scrutiny as the drug regulatory bodies had to become alert and see how these pharmacies manufactured the medicines. Do you recall Valsartan and Losartan, the drugs responsible for lowering blood pressure? The regulatory bodies showed their responsibility of removing more than 12 million bottles from the market in 2018 only because they consisted of a huge number of Nitrosamines. 

Which Batch Of Bottles Was Recalled? 

To be precise, FDA recalls Duloxetine bottles in lot No. 220128, which was going to get expire in December 2024. 

What Should Be Done When Medicines Are Recalled?

Johnson Arbor relaxed the individuals who were taking this anti-depressant, saying that the recall did not include all the formulations. So, the patients are required to read if their prescription is part of the recall or not. If you spot the name, then the FDA recommends continuing it as the medication cannot afford to stop suddenly. Because then you will face headaches, depression, anxiety, and vomiting. Therefore, consult with your doctor about the nearest potential treatment. 

Conclusion

We need to be grateful that FDA recalls Duloxetine, otherwise patients using Duloxetine would have been unknowingly inviting Cancer to invade their body. We hope the blog answered all of your questions of why FDA recalls Duloxetine and that you now know what to do when medicine gets recalled.