Yesterday, the FDA warned that “certain samples of sitagliptin” were found to contain a nitrosamine called NTTP (nitroso-STG-19). NTP can cause cancer. So there is a concern.
How serious is the concern? We do not know yet. Our lawyers are not yet taking new Januvia cancer lawsuits. But this is something to keep an eye on… because we do not know much yet.
January 2023 Update
Merck reported to federal regulators submitted explaining how NDMA found itself in some batches of the drugs. The work has the potential to prevent hundreds of thousands of diabetes patients from being exposed to low levels of potentially cancer-causing nitrosamines, an impurity that’s been found in Merck’s Januvia and Janumet, along with many other widely used medications. Merch reportedly believes it can solve the problem by the end of 2023…. wait…what? The impurity problem comes during storage. And, oh yeah, during manufacturing. They can get that fixed by the end of the year? What about in the meantime?
Tests Show Sitagliptin Contains NTTP
Sitagliptin is the active ingredient in the popular diabetes drugs Januvia and Janumet, which are manufactured by Merck & Co. Sitagliptin is also used as the active component in several other brand-name diabetes drugs. The FDA recently announced that samples of sitagliptin were found to be contaminated with carcinogenic nitrosamine called NTTP.
Long-term users of Januvia, Janumet, or other diabetes drugs containing sitagliptin may be at increased risk for various types of cancer due to exposure to NTTP. “May be” are the operative words here. We just don’t know yet.
About Januvia and other Sitagliptin Drugs
Sitagliptin is a drug that is used for the treatment of type-2 diabetes and is sold under the popular brand names Januvia and Janumet. Sitagliptin belongs to a class of drugs known as DPP-4 inhibitors.
Januvia, Janumet, and other drugs containing sitagliptin help control type-2 diabetes by increasing certain chemicals in the body which cause the pancreas to produce and release more insulin into the blood. Sitagliptin also causes the liver to decrease the production of glucose when blood sugar levels are already high.
Sitagliptin was developed by the pharmaceutical company Merck. Merck obtained initial FDA approval for the drug back in October 2006 and it is sold as the popular brand name diabetes drugs Januvia and Janumet.
Januvia is one of Merck’s top-selling drugs. In 2021, reported sales of Januvia generated just over $3.3 billion in revenue for Merck. Sitagliptin is also the active component of another Merck drug called Janumet. Janumet generated $1.9 billion in revenue for Merck in 2021. Januvia and Janumet rank 3rd and 5th on Merck’s list of top-selling drugs.
Carcinogenic Chemical Found in Sitagliptin (Januvia)
On Tuesday, August 9, 2022, the Food and Drug Administration (FDA) issued a public safety announcement warning that it recently became aware that “certain samples of sitagliptin” were found to contain a nitrosamine called NTTP (nitroso-STG-19).
Nitrosamines are known to be human carcinogens and lab testing has linked exposure to nitrosamines to increased risks of cancer. Nitrosamines occur regularly in the natural world and can be found in meat, water, dairy products, and vegetables. Everyone is exposed to low levels of nitrosamines regularly. The risk of cancer occurs with prolonged exposure to high levels of nitrosamines.
The specific nitrosamine found in Januvia was NTTP, which is just one of many different compounds in the nitrosamine family. No scientific studies have ever been conducted specifically on the toxicity of NTTP. However, studies on various other types of nitrosamines have conclusively linked chronic, high-level exposure to increase rates of cancer.
The extent of the Nitrosamine Contamination in Januvia Remains Unclear
The announcement from the FDA about the NTTP nitrosamine contamination in sitagliptin is very vague about the extent of the contamination. The FDA announcement does not explain any of the details about how the NTTP impurity was discovered in sitagliptin. Rather, the announcement simply states that:
FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes mellitus.
The FDA statement does not indicate how many samples of sitagliptin were found to be contaminated with NTTP. It is not even clear whether the impurity was discovered by Merck or by a third party.
The lack of details about the nature and extent of the NTTP impurity in sitagliptin means that we don’t know how extensive the problem was or is. We don’t know whether Januvia users have been exposed to NTTP at high levels for years, or whether this was just an isolated contamination. It is encouraging that the FDA is leaving the product on the shelves.
Januvia and Pancreatic Cancer
Lawsuits were filed alleging Januvia causes pancreatic cancer. These lawsuits were dismissed last year by a federal court judge because the judge did not believe the plaintiffs’ lawyers did not produce strong enough science to show a link between pancreatic cancer and these diabetes drugs.
The obvious point here is that NTTP has been shown to cause pancreatic cancer. But what does it all mean? Again, we do not know yet.
Januvia and Janumet Lawsuits
The national product liability lawyers at Miller & Zois were investigating whether there were viable Januvia and Janumet lawsuits. Potential plaintiffs in these cases would be anyone who used Januvia, Janumet, or another type-2 diabetes drug that was made with sitagliptin, for at least 1 year and was subsequently diagnosed with any type of cancer.
But… we are not accepting new cases in 2023 and it is incredibly unlikely we ever will. We know that. Merck knows that, too. But it is just incredible how blase these drug companies can be when it comes to putting its customers at risk. Am I oversimplifying a complicated problem? I’m sure. But it is still ridiculous.