According to a news alert posted on bloomberg.com, Merck & Company has discovered that certain lots of its diabetes drug Januvia were contaminated with a probable carcinogen. The impurity was found in the company’s sitagliptin-containing drugs. The Food and Drug Administration stated that it was working with Merck to avoid shortages of medication.
The impurity of concern is called nitrosamine, and its chemical name is sitagliptin. The US Food and Drug Administration reported that is allowing Merck to continue the sale of its sitagliptin medications with higher-than-permitted levels of nitrosamine to avoid shortages.
Merck stated in an email statement that it “detected a nitrosamine identified as NTTP in some batches of our sitagliptin-containing medicines.” Merck & Company is operating with health authorities throughout the world to install additional quality controls to ensure the medications meet the FDA’s interim limits.
Merck did confirm that the company discovered NTTP in three different products that contain sitagliptin: Janumet, Januvia, and Steglujan. Some nitrosamine levels were also discovered in a related extended-release drug, Janumet XR. However, the levels of NTTP were too low to be measured, Merck reported.
Sitagliptin, a medication that helps type 2 diabetes patients control their high blood sugar. Metformin, another popular diabetes drug, was among several other medications recalled due to dangerous levels of nitrosamine. Four years ago, drug companies found that certain blood pressure pills had been tainted with N-Nitrosodimethylamine, or NDMA. NDMA can increase the risk of cancer when a patient has prolonged exposure to the chemicals. The nitrosamine found in sitagliptin is known as Nitroso-STG-19, or NTTP.
The FDA permits 37 nanograms per day of nitrosamine in medication, but the agency is allowing up to 246.7 nanograms in sitagliptin to help avoid critical shortages of the drug. The FDA also recommends that patients continue with their sitagliptin medications until they speak with their health care provider about a change in treatment.
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