The FDA has identified yet another contaminate in valsartan containing drugs found in several popular cardiovascular drugs. In July, the FDA discovered the first contaminate and issued a recall. Now, three more lots of the drugs contain a second impurity, N-Nitrosodiethylamine, or NDEA, which can also cause cancer.
About Valsartan
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.
Another Valsartan Contaminate
Now, the FDA announced that three additional lots of valsartan drugs made by Torrent Pharmaceuticals contain a second carcinogen, N-Nitrosodiethylamine, or NDEA. Exposure to NEDA can cause liver damage including necrosis of the liver. It hasn’t been tested in humans, but rats ingesting NDEA had increased fetal mortality rates.
The agency began testing the medication after a recall in July. The first recall was when the FDA discovered several pills that contain valsartan including Diovan, Diovan HCT, Exforge, Exforget HCT or Entresto were tainted with the carcinogen N-nitrosodimethylamine, or NDMA. NDMA is an organic chemical used to make liquid rocket fuel and a byproduct from manufacturing some pesticides and processing fish. Certain chemical reactions can produce NDMA, too. Long-term risks are unclear. But, exposure to high levels could cause liver damage.
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 valsartan medications, and therefore the largest amount of the chemical.
