Valsartan

  • Valsartan

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)

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 Safety Warnings:

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 (Active Pharmaceutical Ingredient) manufacturers are reminded to evaluate processes for unsafe impurities.

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

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

March 12, 2019: The Food and Drug Administration (FDA) approved a new generic version of Valsartan (Diovan) to ease the recent shortage of blood pressure medicine owing to a series of safety recalls.

 

Legal Updates:

Defendants:

  • Zhejiang Huahai

  • Mylan Laboratories Ltd.

  • Princeton Pharmaceutical

  • Solco Healthcare US

  • Aurobindo Pharma

  • Walmart

Defendant Law Firm:

Zhejiang Huahai: Represented by Seth Goldberg of Duane Morris LLP.

Mylan Laboratories Ltd.: Represented by Clem C. Trischler of Pietragallo Gordon Alfano Bosick & Raspanti LLP.

Allegations:

Allegations include that generic valsartan pills were distributed for years with cancer-causing impurities, including NDMA and NDEA, which appear to be a by-product of the drug manufacturing process. Several lawsuits have been filed in recent months by individuals who indicated that they were left with different types of cancer, including liver cancer, kidney cancer, gastric cancer, pancreatic cancer, and other injuries following exposure to NDMA or NDEA.

Plaintiff Steering Committee:

  • Ruben Honik - Golomb & Honik, P.C

  • Daniel Nigh - Levin, Papantonio, Thomas, Mitchell, Rafferty, Proctor, P.A

  • Adam Slater - Mazie Slater Katz & Freeman, LLC

  • Conlee Whiteley - Kanner & Whiteley, LLC

  • John Davis - Slack Davis Sanger, LLP

  • Marlene Goldenberg - Goldenberg Law

  • Behram Parekh - Kirtland & Packard, LLP

  • Andres Rivero - Rivero Mestre LLP

  • Mikal Watts - Watts, Guerra LLP

  • George Williamson - Farr Law Firm

  • Brett Vaughn - Hollis Law Firm

Lawsuit Status:

There are currently 10 class action lawsuits and one individual action pending in District Courts across the USA. Valsartan claims are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J. The number of cases filed is expected to increase with the spread of awareness.

April 9, 2019: A case management order was issued, in which Judge Robert B. Kugler, allowed the direct filing of new cases into the multidistrict litigation(MDL) established in New Jersey.

Important Verdicts & Settlements:

Hundreds of product liability lawsuits have been filed due to side effects of recalled valsartan, losartan, and other blood pressure drugs, but no settlement has been made yet.

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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