Drugs

Merck Fixing Nitrosamine Formation in Januvia Batches

Merck says it has identified the root cause of nitrosamine (NTTP) formation in certain Januvia (sitagliptin) batches, and it has provided a detailed report to FDA and other health authorities The drug is indicated for treating Type 2 diabetes mellitus.

Last year, FDA said it became aware of the nitrosamine impurity in certain samples of sitagliptin (see earlier story). To avoid a shortage, the agency said at the time that it would not object to the temporary distribution of sitagliptin containing NTTP above the acceptable intake limit of 37 ng per day, and up to 246.7 ng per day.

NTTP belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens, according to the agency. “Although there are no data available to directly evaluate the carcinogenic potential of NTTP, FDA used information available on closely related nitrosamine compounds to calculate lifetime exposure limits for NTTP,” it says.

Over the past few years, numerous recalls have been issued due to unacceptable levels of nitrosamines in drugs. In 2020, FDA issued a guidance, “Control of Nitrosamine Impurities in Human Drugs,” recommending steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The document also describes conditions that may introduce nitrosamine impurities.

Merck says in a statement that it has already implemented additional quality controls and expects to be able to consistently reduce NTTP levels to meet the long-term acceptable daily intake level this year, “although the specific timeframe will be based on the progress of timing to institute process modifications and on engagement with FDA and other health authorities.”

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