Today, the FDA advised that it “recently became aware of a nitrosamine impurity, Nitroso‑STG‑19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes mellitus. To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, the FDA will 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.” See the FDA’s full statement on the issue here.
It seems like we are all waiting for the other shoe to drop as this adds to the number of products that have fallen victim to the nitrosamine contamination fiasco. The FDA and industry have been working diligently to determine the root cause of these issues as well as how to prevent them in the future. Right now, the Agency has no other option except to be reactive as well proactive to keep from creating drug shortages for products found to contain a nitrosamine. Whether it is from interaction of inactive ingredients, storage in heat, formation on long term stability, moisture, or some other not yet elucidated process, it seems like we learn more each day but also see additional products added to the list of vulnerable entities.
Stay tuned to the FDA webpage (here) to learn more about nitrosamine formation and contamination and to watch for other drug safety and availability announcements.