- In a statement, the FDA says its investigation into an impurity in valsartan, used to treat high blood pressure and heart failure, appears to point to changes in the manufacturing process at bulk manufacturer Zhejiang Huahai Pharmaceutical in China. Further testing is in process to confirm this.
- The impurity, called NDMA, is a probable carcinogen at low doses, although the agency says its scientists have estimated a miniscule theoretical risk to patients. Specifically, if 8,000 users consumed the highest dose of the tainted valsartan (320 mg) for four years (the estimated time the NDMA-containing product has been on the U.S. market) there could be one additional case of cancer over the lifetimes of the 8,000 patients.
- Four companies have voluntarily recalled valsartan products, including Teva Pharmaceutical Industries (TEVA -0.4%). 13 other ingredient manufacturers who supply more than 20 drug firms with product have been contacted and testing will be done to determine the presence of NDMA in their respective ingredients.
- Selected tickers: (PRGO +1.8%)(MYL +0.5%)
- Previously: Teva recalls certain lots of valsartan and valsartan hydrochlorothiazide tablets due to impurities (July 16)
- Now read: Your Daily Pharma Scoop: Fasinumab Positive, Teva And Sun Gets FDA Approval
Original article