Several drug companies have voluntarily recalled their blood pressure and heart medication containing valsartan. Researchers discovered that the drug could be contaminated with The impurity, N-nitrosodimethylamine or NDMA. NDMA can cause cancer. If you developed cancer from using valsartan, keep your medication. Testing your medication for NDMA can help prove if manufacturers are responsible for your 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 FDA doesn’t know exactly how the medication became tainted. However, it postulates a combination of conditions contributed. For example, chemicals, processing conditions, and production steps, possibly led to NDMA. But, the FDA does not know for sure.
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. the agency identified 13 other API manufacturers who supply more than 20 drug companies that make valsartan for the U.S. market. We made plans to determine if their products could also contain NDMA. Over 8,000 people received the highest dose of valsaratan medications, and therefore the largest amount of the chemical.