The FDA said Aug. 9 tests of samples of a Merck diabetes drug detected substances that can cause cancer, and to avoid shortages, the department said it would allow increased levels of the carcinogen by nearly 150 percent.
Production for Januvia, Janumet and Steglujan, Merck's brand-name drugs for the generic sitagliptin, will temporarily be allowed to boost the mass of the carcinogenic impurity from 37 nanograms per day to 246.7 nanograms per day. It's dangerous for patients to stop taking the Type 2 diabetes drug, so the FDA advises continued use of the drug despite the potential carcinogen.
The boost in allowed nanograms "presents minimal additional cancer risk," according to the FDA.