Merck’s Type 2 Diabetes Drugs Potentially Contaminated With Nitrosamines
The FDA has issued a notice about elevated levels of potentially carcinogenic nitrosamines found in Merck’s diabetes drugs Januvia and Janumet.
Both drugs contain the active ingredient sitagliptin which reduces blood sugar levels in patients with type 2 diabetes.
To avoid a drug shortage the agency is allowing temporary distribution of the products that may contain nitrosamine above the acceptable intake limit of 37 nanograms per day, and up to an interim limit of 246.7 nanograms per day.
Patients are advised to continue taking the drugs when clinically appropriate to avoid gaps in treatment, the agency said.