Despite the FDA’s repeated efforts to clear the U.S. drug supply of hypertension drugs tainted with impurities believed to cause cancer, they keep being discovered. The most recent recall is 10 lots of losartan from Teva Pharmaceutical made with a tainted active pharmaceutical ingredient (API) from Hetero Labs.
The Israel drugmaker is recalling six lots of 50 mg losartan and four lots of 100 mg losartan because the API from which they were made had N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the FDA’s recently determined 9.82 ppm acceptable strength.
The bulk lots were sold exclusively to Golden State Medical Supply of Camarillo, California, which sold them under its own name.
This recall comes on top of the 35 lots of losartan Teva recalled in April because they contained unaccepted levels of the impurity that creates a risk of getting cancer. A week later, generic drug maker Torrent Pharmaceuticals recalled more than 100 lots that were made with the same API from Hetero.
It has been not quite a year since the FDA and regulators in Europe discovered the impurity N-nitrosodimethylamine (NDMA) in a valsartan API made by China’s Zhejiang Huahai Pharmaceutical, leading to a global recall. A deeper dive uncovered that the contaminants NDMA, NDEA and NMBA, which are considered probable carcinogens, can form through specific and commonly used manufacturing processes.
As more of the impurities were discovered, recalls piled up, and shortages materialized for some of the common blood pressure meds. This led the FDA to determine what it considers an acceptable level of the impurities. It also has led the agency to tell consumers to continue to take their drugs, even if they are suspected of contamination. The agency has decided there is a higher risk of cardiovascular problems affecting patients not taking their medicines than of getting cancer from them.