Merck discovers 'root cause' of nitrosamine levels in blockbuster diabetes drugs
Merck has identified what caused levels of the nitrosamine NTTP to appear in batches of its blockbuster diabetes drugs, the company confirmed on Wednesday.
An unnamed source told Bloomberg, which first reported the news, that NTTP contamination in certain batches of its sitagliptin diabetes products Januvia and Janumet occurred during storage and manufacturing processes.
The FDA said last August that it became aware of a nitrosamine impurity in certain samples of Merck’s type 2 diabetes drug Januvia. In order to avoid a shortage of the blockbuster drug, the agency temporarily allowed higher impurity levels than the acceptable intake limit.
The agency added in a statement at the time that given sitagliptin — the drug name for Januvia — is a prescription drug, “it could be dangerous for patients” with type 2 diabetes to stop taking it without talking to their health care professional first.
Normally, if a drug contains nitrosamine levels above a certain accepted daily limit, the federal agency recommends a recall.
A Merck spokesperson told Endpoints News on Wednesday that:
Merck has identified the root cause of the nitrosamine, NTTP, formation in certain batches of its sitagliptin-containing products and has submitted a detailed report of its findings to relevant health authorities.
The company has already instituted 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.
Nitrosamine impurities have impacted multiple companies — such as back in 2019, when the FDA found nitrosamine in drugs like Pfizer’s Chantix and Accupril, as well as metformin from multiple companies.
Nitrosamines, per the FDA, can increase the risk of cancer if patients are exposed above the acceptable limits for a long period of time.
More recently, Phathom Pharmaceuticals had its launch of vonoprazan to treat Helicobacter pylori (H. pylori) bacterial infections delayed after trace levels of nitrosamines were found in commercial batches.