Valsartan

  • Valsartan

Valsartan belongs to a class of drug called Angiotensin II Receptor Antagonist and is used to treat Hypertension, Congestive heart failure.

Diovan (Valsartan) was manufactured by Novartis International AG and was approved by 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 a long term.

Immediately, 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, they are

  • Irbesartan (Avapro)

  • Losartan (Cozaar)

  • Olmesartan (Benicar)

  • Candesartan (Atacand)

These above drugs are suspected to cause similar injuries because they share the same manufacturing process as that of Valsartan.

Serious Alleged Injuries may include:

  • Stomach cancer
  • Liver cancer
  • Colorectal cancer
  • Lymphoma
  • Esophageal Cancer
  • Bowel cancer
  • Liver failure

FDA Timeline:

  • July 18, 2018: Teva Pharmaceuticals USA labeled as Major Pharmaceuticals,  Prinston Pharmaceuticals Inc. labeled as Solco Healthcare LLC and Teva Pharmaceuticals labeled as Actavis LLC recalled because of related to the NDMA impurity detected in the valsartan API.

  • August 2, 2018: The recalled valsartan-containing product information is updated and API manufacturers are reminded to evaluate processes for unsafe impurities.

  • September 28, 2018: Zhejiang Huahai Pharmaceuticals is placed on import alert by FDA.

  • October 30, 2018: An alert related to ScieGen’s irbesartan recall due to NDEA      (N-Nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen) is raised by FDA.

  • November 9, 2018: One lot of Sandoz losartan potassium and hydrochlorothiazide was recalled due to NDEA.

  • November 21, 2018:  Mylan’s valsartan products were recalled due to NDEA

  • November 27, 2018: Teva’s valsartan products were recalled due to NDEA

  • December 20, 2018: Torrent’s valsartan products were recalled due to NDEA

  • January 2, 2019: Aurobindo recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to detection of NDEA.

  • January 18, 2019: Solco Healthcare’s irbesartan  products were recalled due to NDEA

  • January 23, 2019: Teva voluntarily recalled losartan products. Torrent Pharmaceuticals expanded its voluntary recall to include six additional lots of  losartan potassium and hydrochlorothiazide combination tablets.

  • January 28, 2019: The FDA provided two possible reasons for the carcinogenic impurities in Valsartan. It suspects the impurities may be formed when specific chemicals and reaction conditions are present during the manufacturing processes and could result from the reuse of materials such as solvents.

Legal Updates:

There are currently 10 class action lawsuits and one individual action pending in District Courts across the USA. The process of consolidation is in discussion; a motion is also filed with the U.S. Judicial Panel on Multidistrict (JPML); nothing has been finalized yet. The number of cases filed is expected to increase with the spread of awareness.

Evidence:

  • Usage in Pharmacy Records
  • Duration of Usage
  • Proof of Injury in Medical Records.

Medical Record Review and claim validation of Valsartan case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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