Merck attempts to reduce levels of carcinogenic compounds in diabetes drugs

pharmafile | January 20, 2023 | News story | Medical Communications  

Pharmaceutical company Merck has announced that it is attempting to reduce levels of a cancer-causing compound which has been found in its popular type 2 diabetes drugs. The compound, known as nitrosamines or NTTP, often emerges from chemical reactions that can take place throughout the manufacturing process.

These compounds are naturally found in fresh fruits and vegetables, grilled meats and fish, and in water and the air.

Merck appears to have found the source of the nitrosamines, forming in batches of products containing sitagliptin. This substance is an active ingredient in Merck’s Januvia, Janumet and Steglujan, all of which are used to control blood sugar levels in type 2 diabetes patients.

The FDA has said that people who have been exposed to above what it considers “acceptable levels” over long periods of time can have an increased risk of cancer. Patients who take the affected drugs are recommended to talk to their healthcare providers before deciding whether to stop using the medication over a cancer risk.

Merck has commented: “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.”

The FDA also commented: “When we identify drug quality lapses that pose potential risks for patients, we make every effort to understand the issues and provide our best recommendation to the public as quickly and accurately as possible. We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits so that patients can continue taking their medicines without concern.”


Betsy Goodfellow

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