Samples of Popular Diabetes Drug Contain Potential Carcinogen, F.D.A. Says

The Food and Drug Administration said traces of a potential carcinogen were found in a sample of a popular diabetes drug manufactured by Merck. This is the latest example of an impurity detected in a top-selling drug.

Millions of people with type 2 diabetes rely on the drug sitagliptin to control high blood sugar levels. Merck markets the drug as Januvia and Janumet. Last year, sitagliptin was Merck’s third-best-selling product with more than $5 billion in revenue.

Despite the impurities found in some batches, the FDA temporarily allows Merck to continue marketing the drug, saying the patient’s urgent medical needs outweigh the risks. patients may be at risk of stopping taking sitagliptin without first consulting a health care professional,” the agency said. in a statement.

Merck, which was the first to detect and report the contamination to regulators, said it was trying to address the issue and was working with health authorities around the world. I have” approved in 2006.

The impurity known as NNTP belongs to a family of nitrosamine compounds that have been found in many pharmaceuticals in recent years.Since 2018, federal regulators have warned the public to: Nitrosamine contamination A sample of the heartburn remedy Zantac rifampin and the Smoking cessation drug Chantix.

FDA calls NTTP “Possibly human carcinogen, mainly based on laboratory tests. The agency said it lacked data to directly assess the carcinogenicity of NTTP and instead used information on closely related compounds to determine exposure limits. Scientists at our institution set his lifetime exposure to nitrosamines on medication at 37 nanograms per day, while up to 246 nanograms is permissible for sitagliptin for the time being.

In that statement, the FDA called the additional cancer risk “minimal.”

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