Valsartan Lawsuit

Updated September 27, 2020, A Valsartan lawsuit is a legal claim for money damages brought by a consumer who took the high blood pressure drug and was subsequently diagnosed with cancer. The lawsuits allege that many batches of Valsartan from 2012 to 2018 were contaminated with NDMA, a probable carcinogen.

Three different companies have recalled heart medications containing the active ingredient valsartan over concerns the drugs may be tainted by a cancer-causing substance, going back at least the last four years, according to the U.S. Food and Drug Administration.
The contamination is being attributed to changes in the facility’s manufacturing process dating back to 2012, according to a notice by the European Medicines Agency. The FDA told Drugwatch, “The amount of the impurity varies in the firm’s (active pharmaceutical ingredient) batches, but we believe some levels of the impurity may have been in the valsartan-containing products for as long as four years.”

Valsartan belongs to a class of drugs called Angiotensin II Receptor Antagonist and is used to treat high blood pressure (Hypertension), and Congestive heart failure.

Diovan (Valsartan) was manufactured by Novartis International AG and was approved by the FDA on August 14, 2002. Diovan lost its patent in September 2014. The launch of the generic drug had been on hold since patent expiry due to regulatory problems with the FDA. In 2014, a US-based Ohm Laboratories (Ohm), a subsidiary of Ranbaxy Laboratories, was the first to get the approval from FDA for generic Valsartan. Thereafter, many generic versions of Valsartan came into the market via many other pharma companies.

The usage of Diovan had no evidence of any adversity in its entire span, but the FDA did find that the generic versions of Valsartan were causing issues. The most serious issue reported was that it had the presence of an impurity called N-Nitrosodimethylamine (NDMA), which was believed to be formed as a byproduct through a chemical reaction. Not only was this an impurity, but a concern was also raised when it was detected that NDMA is carcinogenic and can lead to cancer in people consuming this drug for the long term.

Immediately, the FDA called for its largest recall of Class I drug, Valsartan on 13 July 2018. The following manufacturers recalled their Valsartan containing drugs.

Recalled Products:

Medicine Company Valsartan – Major Pharmaceuticals

Valsartan –  Solco Healthcare

Valsartan –  Teva Pharmaceuticals Industries Ltd

Valsartan/Hydrochlorothiazide (HCTZ) –  Solco Healthcare

Valsartan/Hydrochlorothiazide (HCTZ) – Teva Pharmaceuticals Industries Ltd

The exact nature of injuries and its effects on the human body is still being studied to derive any strong conclusions. Meanwhile, patients consuming these generic drugs and facing injuries are advised to come ahead.

Along with Valsartan, there are other generic drugs belonging to the same class which can come under the FDA radar due to similar issues, which are:

  • Irbesartan (Avapro)

  • Losartan (Cozaar)

  • Olmesartan (Benicar)

  • Candesartan (Atacand)