FDA Finds Carcinogen In Merck’s Diabetes Drug, Allows Continued Sales To Avoid Shortage

The US FDA has found traces of contaminants in certain samples of Merck’s popular diabetes drug Januvia (sitagliptin). The drugmaker has confirmed that some batches of the drug were found to contain Nitroso-STG-19 (NTTP), a possible carcinogen.

Januvia is essential for some Type 2 diabetes patients to manage their high blood sugar. To prevent a potential shortage of the drug, the FDA is temporarily allowing Merck to continue to sell Januvia with NTTP above the agency’s acceptable daily intake of 37 ng. According to calculations, the difference in cancer risk would be minimal, the agency said. However, the FDA would not accept sales of drugs containing daily intake levels of 246.7 ng and above. 

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Contaminations In Drug Products

NTTP belongs to a class of compounds called nitrosamines, some of which are thought to be carcinogenic, or cancer-causing. The compounds are common in daily life, and are found in water and food. However, only prolonged exposure to higher-than-acceptable levels of nitrosamines could increase the risk of cancer. 

Nitrosamine contamination has plagued many drug companies in recent years, and has forced some to recall batches of drugs. N-nitrosodimethylamine (NDMA), another nitrosamine, has been repeatedly found in metformin, a diabetes drug. Metformin recalls began in early 2020, with New Jersey-based Viona Pharmaceuticals recently recalling 23 lots of metformin this January. 

Pfizer had to recall batches of Chantix, its anti-smoking treatment due to the presence of nitrosamines. The contamination issue has since extended to blood pressure medications Accuretic and Accupril, forcing Pfizer to stop selling the drugs. 

Merck has asserted that there would be no significant impact to the supply of Januvia. The company has also implemented more quality controls to make sure its drugs will satisfy the FDA’s interim limits. 

News of the contamination caused the company’s shares to dip sharply before recovering up 1.2% at closing. 

Author

Joy Lin

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