FDA Says It Found Possible Carcinogen in Some Merck Januvia Samples

Signage is seen at Merck & Co. headquarters in Kenilworth, New Jersey, U.S. November 13, 2021. REUTERS/Andrew Kelly/File Photo

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Aug 9 (Reuters) – The U.S. Food and Drug Administration said on Tuesday that some samples of sitagliptin, a compound in Merck’s diabetes drug Januvia (MRK.N), were contaminated with a possible carcinogen.

The agency said it would not object to the temporary distribution of sitagliptin containing the impurity above the acceptable intake limit to avoid a shortage.

Merck shares, which were not immediately available for comment, fell sharply before recovering to trade up 0.8% at $89.27.

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Sales of Januvia and a related drug called Janumet totaled $1.23 billion in the second quarter.

The impurity Nitroso-STG-19, also known as NTTP, belongs to the class of nitrosamine compounds, some of which are classified as probable or possible human carcinogens, based on laboratory tests, the agency said. . (https://bit.ly/3zHj8tz)

Agency scientists assessed the risk of exposure to NTTP at tentatively acceptable intake levels of up to 246.7 nanograms per day and determined that it poses minimal additional cancer risk compared to a lifetime exposure to NTTP at the level of 37 nanograms per day.

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Reporting by Ankur Banerjee in Bengaluru; Editing by Aditya Soni

Our standards: The Thomson Reuters Trust Principles.

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