FDA: Possibly contaminated sitagliptin may be distributed to avoid shortage
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The FDA announced it has learned that some samples of sitagliptin, used to treat type 2 diabetes, may contain a “nitrosamine impurity,” Nitroso-STG-19 or NTTP, which may be a human carcinogen.
The FDA hopes to avoid a shortage of the medication by temporarily allowing distribution of sitagliptin (Januvia, Merck) containing NTTP for doses up to 246.7 ng per day, which is above the currently identified acceptable limit of 37 ng per day, according to an agency press release.
“Agency scientists evaluated the risk of exposure to NTTP at interim acceptable intake levels up to 246.7 ng per day and determined that it presents minimal additional cancer risk when compared to a lifetime of exposure to NTTP at the 37 ng per day level,” the release stated.
Manufacturers of products containing sitagliptin should notify the Drug Shortages Staff at the Center for Drug Evaluation and Research if they test a product and find a level of NTTP in excess of 37 ng for a daily dose. The FDA will decide whether those products should be distributed on a case-by-case basis, according to the release.
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