What is Valsartan?

Valsartan is a generic drug used to treat high blood pressure and heart failure. Since July 2018, the medication has been at the center of concern because large batches of it may have been contaminated with a possible carcinogen.

Valsartan is advertised as the therapeutic equivalent to Diovan, the name brand version of the drug. 

Has Torrent Pharmaceuticals Valsartan been recalled?

Due to concern over possible contamination of the drug, Torrent Pharmaceuticals Limited has announced a voluntary recall of 14 batches of valsartan. The recall was announced on August 14, 2018. This marks an expansion of an initial recall of possibly contaminated valsartan, says CVS Caremark.

The U.S. Food and Drug Administration (FDA) has made note of the Torrent Pharmaceuticals valsartanrecall on its website. Healthine reports that Torrent Pharmaceuticals has instituted four recalls of blood pressure medications since December. 

How was Valsartan Contaminated?

According to the FDA, valsartan may have been contaminated with N-nitrosodimethylamine (NDMA), a possible carcinogen. Allegedly, NDMA was introduced accidentally into valsartan during the manufacturing process at Zhejiang Huahai Pharmaceuticals.

It’s suspected the contamination occurred because of certain chemical reactions that took place during manufacturing. Zhejiang Huahai Pharmaceuticals stated that the contamination resulted after a change in manufacturing procedures and has since been contained.

However, Zhejiang Huahai Pharmaceuticals has been put on an important alert because of the contamination problem, so drugs and other pharmaceutical products produced by the company are not currently permitted to enter the U.S.

Is the Problem Widespread?

Experts initially thought that the problem of contamination was contained, but now, reports indicate that contaminated valsartan may have been produced in Mylan, India, as well.

Additionally, numerous companies produce valsartan through Zhejiang Huahai Pharmaceuticals, so valsartan made by multiple companies may have been affected.

In an article detailing a slew of recalls of blood pressure medications, Healthline writes that Teva Pharmaceuticals, Mylan and Aurobindo Pharma USA Inc. are among the pharma companies recalling valsartan-containing drugs.  Mylan is recalling all lots of drugs containing valsartan, whereas other companies are only recalling selective lots. 

Affected drugs may include valsartan as well as drugs that combine valsartan with other cardiovascular medications such as amlodipine and hydrochlorothiazide.

How is the Contaminated Torrent Pharmaceuticals Valsartan Dangerous?

Torrent Pharmaceuticals valsartanmay be contaminated with N-nitrosodimethylamine (NDMA), which the International Agency for Research on Cancer has identified as a probable carcinogen.

The FDA reports that thus far, Torrent Pharmaceuticals has not received any reports of adverse events related to its recall. However, lawsuits have been filed against Zhejiang Huahai Pharmaceuticals and other companies by patients who claim they developed cancer as a result of taking contaminated valsartan. Other patients claim they suffered financial harm because they received a medication different from what they were sold — a drug therapeutically equivalent to Diovan.