Valsartan Recall Due To Cancer Risk
The FDA has issued a recall for Diovan, Diovan HCT, Exforge, Exforge HCT and Entresto from multiple manufacturers. Researchers discovered that these drugs could be contaminated with N-nitrosodimethylamine or NDMA. NDMA can cause liver cancer.
Manufactured by Major Pharamascetucials, Teva Pharmaceuticals, and other companies, valsartan is a cardiovascular drug to treat high blood pressure or hypertension. The FDA approved the medication in adults and children aged 6 and up. The drug can also treat adults for heart failure along with reducing the risk of death in those who recently had a heart attack. It is available as a stand-alone medication or as valsartan HCTZ, which combines valsartan with the diuretic hydrochlorothiazide. Common medications containing the valsartan are Diovan, Diovan HCT, Exforge, Exforge HCT or Entresto.
In May 2018, the European Medicines Agency announced that investigators found a potentially dangerous impurity in valsartan medications sourced from Zhejiang Huahai Pharmaceuticals, a Chinese pharmaceutical manufacturer. They identified the substance as N-nitrosodimethylamine or NDMA. Healthcare authorities have classified NDMA as a possible human carcinogen. Then, Europe began recalling medications potentially tainted with valsartan along with urging pharmacies to pull the medication from the shelves.
The announcement also suggests that changes in production at the Chinese manufacturing facility caused the NDMA presence. Also, the facility made the changes in 2012. Therefore, the tainted valsartan could have been on the marketing for several years before the recent discovery.
The U.S. Valsartan Recall
In July 2018, the FDA has asked three manufacturers of generic valsartan medication to voluntarily recall it from the U.S. market. Also, the agency asked pharmacists to return contaminated medications to the manufacturers. Furthermore, the agency is continuing to investigate the NDMA levels to asses cancer risks in those who already ingested the medication.