NDMA is an organic chemical that forms both naturally in food and as a result of industrial processes. Research shows that NDMA can result from the chlorination of waste water and drinking water, along with other factors. The FDA learned about the presence of Nitrosamines impurities known as Nitroso-STG-19 in Sitagliptin phosphate containing medications like Januvia in 2022.
Preliminary testing in 2022 revealed the presence of the carcinogen nitrosamine impurity, Nitroso-STG-19 (known as NTTP) in Januvia. NTTP belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens (substances that could cause cancer), based on laboratory tests.
Based on lab tests, Nitrosamines is classified as a probable human carcinogen. Low levels of Nitrosamines have been found in common items for human consumption, including cured meat, beer, tobacco smoke, and fish.
Nitrosamines can be found in drinking water that has been broken down through various industrial processes, including exposure to dimethylhydrazine, a component commonly found in rocket fuel. It can also be a byproduct of specific chlorination and can be found in common pesticides. There are low levels of Nitrosamines found in common foods, but their presence in medications like Januvia has been a cause for concern within the medical community.
Industries that process an environmental compound called alkylamine can unintentionally create Nitrosamines from specific chemical reactions. This occurrence is common in industries such as:
Exposure to Nitrosamines has been shown to cause cancer in both animals and humans. It can cause non-emergent medical conditions like jaundice, stomach cramps, and dizziness, but can also cause more serious medical issues like kidney and liver failure, internal bleeding, and various forms of cancer.
Preliminary testing by the FDA show some samples of Januvia contain higher levels of nitrosamine impurity, Nitroso-STG-19 (known as NTTP). The concern with this nitrosamines is that it can potentially cause cancer, even in small amounts. The longer the exposure to this carcinogen, the higher the chances are for developing cancer and other health problems such as liver disease. Nitrosamines exposure from Januvia (Sitagliptin Phosphate) is linked to sever cancers such as:
If you’ve been diagnosed with cancer, you may be entitled to compensation. The Januvia Lawsuit Justice Center has been studying the effects of Nitrosamines diligently and is ready to get you connected to the right resources to fight the big brands like Januvia and get you the compensation you deserve.
When you file a lawsuit , your lawsuit will become part of an MDL, or Multi-District Litigation. Through an MDL, each plaintiff’s award is based on their unique circumstance.
If you’ve been impacted by Januvia and exposure to NDMA, Call our justice center today. We’re standing by, ready to hear your story, and connect you to an attorney that will fight on your behalf!
It is important for pharmaceutical companies to have their drugs approved by the FDA (Food and Drug Administration); otherwise, they can’t sell their product in the market. In order to get FDA approval, a company must conduct lab testing of its drug through animal and human trials. Once they do this, they must submit their data to the FDA. The FDA examines and evaluates the data collected from the company and determines whether it can be approved or not.
This approval is dependent on one major factor, which is, does the drug have higher risks than benefits? Once the FDA determines this factor, it proceeds with approval or rejection.
Sitagliptin, sold under the brand name Januvia among others, is an anti-diabetic medication used to treat type 2 diabetes. In the United Kingdom it is listed as less preferred than metformin or a sulfonylurea. It is taken by mouth. It is also available in the fixed-dose combination medication sitagliptin/metformin (Janumet, Janumet XR).
Sitagliptin was developed by Merck & Co. and approved for medical use in the United States in 2006. In 2019, it was the 88th most commonly prescribed medication in the United States, with more than 8 million prescriptions.
Sitagliptin is used to treat type 2 diabetes. It is generally less preferred than metformin or sulfonylureas. It is taken by mouth. It is also available as the fixed-dose combinations of sitagliptin/metformin (Janumet, Janumet XR) and sitagliptin/simvastatin (Juvisync).
Sitagliptin should not be used to treat type 1 diabetes. In December 2020, the U.S. Food and Drug Administration (FDA) approved labeling changes stating that Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metformin hydrochloride extended-release) are not proven to improve glycemic (blood sugar) control in children aged 10 to 17 with type 2 diabetes. The drugs are approved to improve blood sugar control in adults aged 18 and older with type 2 diabetes.
Well, as we mentioned earlier, it is up to the FDA to ensure a drug has higher benefits than risks.
Preliminary testing in 2022 revealed the presence of the carcinogen nitrosamine impurity, Nitroso-STG-19 (known as NTTP) in Januvia. NTTP belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens (substances that could cause cancer), based on laboratory tests.
To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, FDA will not object to the TEMPORARY distribution of sitagliptin containing NTTP above the acceptable intake limit of 37 ng per day, and up to 246.7 ng per day.
FDA also asked, The manufacturer of a marketed product that contains sitagliptin should contact the Center for Drug Evaluation and Research’s Drug Shortages Staff when its testing shows levels of NTTP that exceed 37 ng per day. FDA will determine on a case-by-case basis whether those drugs should be released for distribution.
The FDA noted that it could be dangerous for patients with type 2 diabetes mellitus to stop taking their sitagliptin without first talking to their health care professional. FDA recommends prescribers continue to use sitagliptin when clinically appropriate to prevent a gap in patient treatment.
Every pharmaceutical drug has its side effects, but Januvia (Sitagliptin) is quite harmful because of the unacceptable levels of nitrosamine impurity, Nitroso-STG-19 (known as NTTP). Some people who have routinely used Januvia and other Sitagliptin phosphates medications have been diagnosed with cancer. The primary types of cancer linked to Januvia use include:
The following adverse reactions are reported by brand in its label:
The side effects associated with the presence of NDMA are a clear indication that people who use or have used Januvia (Sitagliptin) for Diabetes may have a potential lawsuit. The side effects don’t have to appear immediately after the use of the drug. If you have any of the cancers stated above, they might be associated with your use of the drug at some point in life. Only a health professional can form a link between your condition and the use of Januvia (Sitagliptin).
The reality is, you cannot ignore any unusual symptoms in your body if you have used Januvia (Sitagliptin) at any point. You don’t have to live in fear, pay huge medical bills, and lose the joy of life because of cancer just because you couldn’t file a lawsuit against the company on time. If you think you have a potential Januvia (Sitagliptin) lawsuit, you should contact us today that so we can help you find the legal protection you need before it’s too late.
You should not use any medicine without a proper prescription. Don’t change, start, or stop any medicine dosage before verifying with your professional health care provider. You can always get more information about the Januvia (Sitagliptin) lawsuit through these frequently asked questions. Visit our Januvia (Sitagliptin) lawsuit (justice center) website for further assistance and information. We have a case specialist who will contact you immediately.
Well, as we mentioned earlier, it is up to the FDA to ensure a drug has higher benefits than risks.
Preliminary testing in 2022 revealed the presence of the carcinogen nitrosamine impurity, Nitroso-STG-19 (known as NTTP) in Januvia. NTTP belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens (substances that could cause cancer), based on laboratory tests.
To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, FDA will not object to the TEMPORARY distribution of sitagliptin containing NTTP above the acceptable intake limit of 37 ng per day, and up to 246.7 ng per day.
FDA also asked, The manufacturer of a marketed product that contains sitagliptin should contact the Center for Drug Evaluation and Research’s Drug Shortages Staff when its testing shows levels of NTTP that exceed 37 ng per day. FDA will determine on a case-by-case basis whether those drugs should be released for distribution.
The FDA noted that it could be dangerous for patients with type 2 diabetes mellitus to stop taking their sitagliptin without first talking to their health care professional. FDA recommends prescribers continue to use sitagliptin when clinically appropriate to prevent a gap in patient treatment.
In the wake of these events, every person who has used Januvia (Sitagliptin) in the past may have a potential case – even you might have one. Don’t shake off this thought and go about your daily life just like that. You might have a potential case. More importantly, you could be exposed to the many serious side effects of using Januvia (Sitagliptin).
Every pharmaceutical drug has its side effects, but Januvia (Sitagliptin) is quite harmful because of the unacceptable levels of nitrosamine impurity, Nitroso-STG-19 (known as NTTP). Some people who have routinely used Januvia and other Sitagliptin phosphates medications have been diagnosed with cancer. The primary types of cancer linked to Januvia use include:
The following adverse reactions are reported by brand in its label:
It is simple, if you want compensation or recovery for the damages you had to bear, file a lawsuit. Legal fight against Januvia (Sitagliptin) will not disappoint you. Through Januvia (Sitagliptin) lawsuit, you can recover the following damages among many others.
The stress of medical bills can affect your physical and mental health. The bills you are paying for the diseases caused by Januvia (Sitagliptin) are refundable. You have the right to claim for your past and future medical bills. The bills you have paid might have been a result of your use of Januvia (Sitagliptin). In the worst case scenario, your cancer diagnosis might be because of this medicine.
When you file a lawsuit against the company, you seek compensation for all the medical bills that you had to pay because of a medical condition that resulted from the use of Januvia (Sitagliptin). Also, a successful lawsuit can get you compensated not only for the past medical bills but all the expenses in the future as well.
At this point, you might have a good idea of how harmful Januvia (Sitagliptin) is for the human body. These medical issues caused by Januvia (Sitagliptin) might disturb a person’s mental health as well. You will not have the ability to focus on your work, due to which you can lose your job. This will affect your mental peace and your future earnings.
Mental pain is different from the physical pain of an injury. You know very well the mental distress you had to go to when you found out that the drug you used for your heartburn could potentially give you cancer. Furthermore, you can’t ignore the anguish, frustration, and depression that might have become a part of your life since you discovered a serious illness. If all of these feelings and sensations have resulted from a condition due to the use of Januvia (Sitagliptin), you have a potential lawsuit.
The side effects associated with the presence of NDMA are a clear indication that people who use or have used Januvia (Sitagliptin) for heartburn or other stomach-related issues may have a potential lawsuit. The side effects don’t have to appear immediately after the use of the drug. If you have any of the cancers stated above, they might be associated with your use of the drug at some point in life. Only a health professional can form a link between your condition and the use of Januvia (Sitagliptin).
The reality is, you cannot ignore any unusual symptoms in your body if you have used Januvia (Sitagliptin) at any point. You don’t have to live in fear, pay huge medical bills, and lose the joy of life because of cancer just because you couldn’t file a lawsuit against the company on time. If you think you have a potential Januvia (Sitagliptin) lawsuit, you should contact us today that so we can help you find the legal protection you need before it’s too late.
You should not use any medicine without a proper prescription. Don’t change, start, or stop any medicine dosage before verifying with your professional health care provider. You can always get more information about the Januvia (Sitagliptin) lawsuit through these frequently asked questions.
We understand this painful and aching journey is not easy for anyone. But we are here to help; if you have any concerns regarding Januvia (Sitagliptin) Lawsuit, contact us today. We will make sure to put you in touch with the right person who can help you with your situation.