Valturna Lawsuit Alleges Hypertension Drug Caused Kidney Failure
An Ohio woman has filed a product liability lawsuit alleging that she suffered kidney damage from Valturna, a hypertension drug that contains the active ingredient from the drug Tekturna.
The complaint (PDF) was filed by Dottie Dodson in Superior Court of New Jersey in Morris County on April 5, alleging that Novartis AG failed to adequately warn about the potential side effects of Valturna before removing it from the market last year.
Dodson began taking Valturna in 2010, after previously taking a combination of Tekturna and Benicar. According to allegations raised in the Valturna lawsuit, the medication caused her to develop chronic kidney disease and end stage renal failure.
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Novartis stopped marketing Valturna in July 2012, following studies that suggested a link between aliskiren, the active ingredient in Tekturna, and kidney disease. Valturna is a combination of aliskiren and valsartan, the later of which is sold under the brand name Diovan.
Last November, a study found that when Tekturna was combined with some other hypertension drugs, it may increase the risk of kidney disease and kidney damage. The study, known as ALTITUDE, was cancelled due to the high risk of injury to subjects involved in the study.
Researchers concluded that the combination of aliskiren with angiotensin-converting enzyme (ACE) inhibitors and angiotensis II receptor blockers (ARBs) is dangerous for patients with Type 2 diabetes or chronic kidney disease. However, the risk may extend to other patients as well.
The FDA revised the warning label for Tekturna and similar drugs in February 2012, warning of potential kidney damage. Novartis then announced it would phase out Valturna by July 2012.
The lawsuit accuses Novartis of failing to properly test the drugs before they were placed on the market. The lawsuit alleges that the drug maker aggressively marketed Tekturna for heart failure and other cardiovascular problems.
Valturna, approved by the FDA in 2009, went on the market based on one eight-week clinical trial of just 1,800 patients, according to the lawsuit. In January, the Justice Department announced it was launching an investigation into potential Tekturna illegal marketing tactics by Novartis.
The lawsuit accuses Novartis of negligence, strict liability, breach of warranty, fraudulent concealment, and violating Ohio consumer protection laws. It seeks both compensatory and punitive damages.
Tekturna (aliskiren) was first approved in the United States in 2007 for the treatment of hypertension. Other drugs that contain aliskiren include Amturnide and Tekamlo. There were about 2.4 million prescriptions filled for aliskiren-containing drugs in 2011 in the United States, according to the FDA.
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