Diabetes Drug Might Pose Cancer Risk: Warns FDA

Merck & Co.’s Januvia and Janumet, which are popular diabetes drugs, could be contaminated with a substance that could cause cancer, the FDA said in an announcement on Tuesday.

An impurity called nitrosamine was found in some samples of the drugs, which are known by the chemical name sitagliptin. The FDA is allowing Merck to continue to sell sitagliptin drugs with higher-than-allowed levels of nitrosamine to avoid shortages.

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‘A widely used diabetes drug that’s the active ingredient in Merck & Co.’s Januvia and Janumet is contaminated with a potential carcinogen.’

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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.

Sitagliptin is a prescription drug used to control high blood sugar in patients with type 2 diabetes mellitus. It could be dangerous for patients to stop taking their medication without first talking to their doctor. The FDA also recommends that prescribers continue to use sitagliptin to prevent a gap in patient treatment.

Merck also recently detected a nitrosamine identified as NTTP in some batches of our sitagliptin-containing medicines. The company is working with health authorities around the world and has put more quality controls in place to make sure the drugs meet FDA limits.

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Merck found NTTP (also called Nitroso-STG-19) in three drugs with sitagliptin: Januvia, Janumet, and Steglujan. Nitrosamine levels in a related extended-release therapy, Janumet XR, were too low to be measured.

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Sitagliptin is one of a string of medications found to be contaminated with nitrosamines since 2018. Metformin, another popular diabetes drug, has been affected previously, as well as some blood pressure pills and Chantix, a drug to help smokers quit.

Four years ago, pharmaceutical companies discovered that some blood pressure pills contained N-Nitrosodimethylamine, or NDMA, which can increase the risk of cancer if you’re exposed to it for a long time. The discovery sparked a years-long examination of common medicines that uncovered several instances of contamination, Bloomberg reported.

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Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables, the FDA said. Exposure to impurities above acceptable levels over long periods can increase the risk of cancer.

The FDA allows 37 nanograms per day of nitrosamine in medication, although it is allowing an interim limit of 246.7 nanograms per day in sitagliptin drugs to prevent shortages. The FDA said its calculations showed the higher limit presents minimal additional cancer risk.

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The company remains confident in the safety, efficacy, and quality of its sitagliptin-containing medicines. No significant impact on the supply of these medicines for patients is anticipated.

Source-Medindia