The Food and Drug Administration (FDA) issued a warning letter to the China-based manufacturer of the active pharmaceutical ingredient (API) in the heart medication valsartan that is under investigation by the agency after the presence of a probable cancer-causing impurity was found in the drugs.
The FDA’s warning letter outlines several manufacturing violations at Zhejiang Huahai Pharmaceutical Co. Ltd (ZHP), in Linhai, Taizhou Zhejiang China, including impurity control, change control and cross contamination from one manufacturing process line to another. The FDA is still looking for the root cause of the impurity, which the agency said previously may have been present in some drugs for up to four years.
Valsartan is in a class of drugs called angiotensin II receptor blockers, or ARBs. The drugs are used to treat high blood pressure and heart failure. On Sept. 28, 2018, the FDA also put ZHP on import alert, which stopped all API made there and finished drug products made using its API from legally entering the United States.
In July, the FDA announced recalls of valsartan due to the presence of N-Nitrosodiumethylamine, or NDMA, in API supplied by ZHP. The FDA launched an investigation into the root cause of the impurity, later expanding its scope to include all manufacturers of API and finished drugs in the ARB class. This resulted in additional recalls of valsartan, as well as the ARBs irbesartan and losartan due to the presence of NDMA and another suspected human carcinogen called N-Nitrosodiethylamine (NDEA).
The FDA has posted a list of recalled valsartan products, valsartan products currently not under recall and recalled irbesartan products, and continues to investigate the issue with ARBs. Patients, health care providers and pharmacists can call the FDA’s Division of Drug Information with any questions regarding the ARB recalls at 855-543-3784.
The FDA advised patients taking any of the recalled ARBs to continue to take their medication until their pharmacist or doctor can provide a replacement.
Source: FDA News Release