HQ Team
January 21, 2023: Merck & Co says it has identified the reason for the presence of a nitrosamine called NTTP in certain batches of its diabetes drugs, according to a report submitted to the US Food and Drug Administration. The cancer-causing nitrosamines were found in Merck’s Januvia and Janumet medicines, along with many other widely used medications.
Both drugs are used to treat type 2 diabetes. Other drugs that carry the same substance, nitrosamines include metformin, and certain blood pressure pills and Pfizer Inc.’s smoking cessation drug, Chantix.
The contaminations was found to have occurred during the storage and manufacturing process.
Januvia was Merck’s third-best-selling drug in 2021, with $3.3 billion in sales, while Janumet collected a revenue of $2 billion the same year, according to Bloomberg
The matter was reported to the FDA in August by Merck, which found the potential carcinogen in Januvia and Janumet during required testing to check for the chemicals. To avoid shortages, the FDA allowed Merck to continue selling the drugs even though they contained nitrosamine that exceeded allowed levels.
Quality Control
The company has reassured that its quality control process for the drugs has improved and will reduce levels of impurity to acceptable levels this year. FDA’s feedback will determine the timeline for the completion of the improvement, according to people familiar with the matter.
The FDA established limits for nitrosamines in medications in 2020.
Nitrosamines have been found in a variety of widely used medications, including treatments for high blood pressure and heartburn. Various animal studies have linked it to cancer. It is believed roughly 75% of nitrosamines are carcinogenic to mammals when in high enough amounts over extended periods.
Nitrosamines have been linked to various types of cancers, such as oesophagal cancer, liver cancer, stomach cancer, kidney cancer, and others.
Some blood pressure pills were found to be contaminated with N-nitrosodimethylamine, or NDMA, in 2018.
