WASHINGTON - The US Food and Drug Administration said on Tuesday certain samples of sitagliptin, a compound in Merck's diabetes drugs Januvia and Janumet, were contaminated with a possible carcinogen.
Merck said it notified authorities it had detected that some batches of the drugs contained the impurities and implemented additional quality controls to make sure its drugs will meet the interim acceptable limits. NTTP belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens, based on laboratory tests, the agency said. Agency scientists evaluated the risk of exposure to NTTP at interim acceptable intake levels up to 246.7 nanogram per day and determined that it presents minimal additional cancer risk when compared to a lifetime of exposure to NTTP at the 37 nanogram per day level.
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