Valturna Lawsuit

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The blood pressure medication Valturna (generic: aliskiren and valsartan) has recently been linked to serious and potentially life-threatening side effects including strokes, kidney damage, high potassium and low blood pressure. These complications have been shown to increase when Valturna is given in combination with the heart/cardiovascular treatment ACE (angiotensin converting enzyme) and ARB (angiotensin receptor blocker) drugs. Individuals with type 2 diabetes are at an increased risk of these side effects.

What’s the problem with Valturna?

Valturna is a blood pressure lowering medication that combines aliskiren and valsartan to decrease substances in the body that narrow the blood vessels. It is designed to keep blood vessels from constricting, which improves blood flow and lowers blood pressure. Manufactured and marketed by Novartis Pharmaceuticals, Valturna was approved by the U.S. Food & Drug Administration (FDA) in September 2009 for the treatment of high blood pressure (hypertension).

In addition to Valturna, other aliskiren-containing blood pressure medications include:

Side Effects of Valturna

Unfortunately, Valturna has recently been linked to a number or serious and potentially life-threatening side effects including:

  • kidney problems
  • strokes
  • non-fatal strokes
  • hyperkalemia (high potassium)
  • hypotension (low blood pressure)
  • renal complications

More moderate side effects associated with Valturna include:

  • light-headedness
  • fainting
  • nausea
  • slow, uneven heart rate
  • weak pulse
  • swelling around the eyes
  • stomach pain or upset stomach
  • diarrhea
  • heartburn
  • itching skin
  • skin rash
  • headache
  • back pain
  • joint pain
  • stuffy nose
  • sore throat
  • cough

Valturna & Kidney Damage

Patients with diabetes or renal (kidney) impairment should avoid taking Valturna in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). In individuals with these conditions, the risks of taking Valturna may outweigh any possible benefit. Signs and symptoms of Valturna-induced kidney damage may include:

  • metabolic acidosis (increased acidity of the body due to the inability to manufacture bicarbonate)
  • inability to excrete potassium
  • rising potassium levels in the serum (hyperkalemia)
  • fatal heart rhythm disturbances (arrhythmias)
  • ventricular tachycardia
  • ventricular fibrillation
  • rising urea levels in the blood (uremia)
  • alteration of thinking
  • inflammation of the heart lining (pericarditis)
  • decreased muscle function because of low calcium levels (hypocalcemia)
  • generalized weakness
  • anemia
  • decreased red blood cell count
  • loss of appetite
  • lethargy
  • fatigue
  • coma

Valturna & Strokes

Many side effects and drug interactions cannot be detected when medications are initially approved by the FDA. Certain complications can only be found after drugs have been used by millions of consumers over an extended period of time. Unfortunately, strokes are one such side effect that have been increasingly reported in Valturna users. Signs and symptoms of a Valturna-induced stroke may include:

  • numbness on one side of the body
  • loss of vision / problems with vision
  • change in alertness
  • sudden intense headache

Valturna Off-Label Marketing

According to reports, Novartis marketed Valturna in an off-label capacity (for which it was neither tested nor approved by the FDA) for usage by type 2 diabetics. In doing so, the pharmaceutical giant engaged in conduct that has been deemed reckless, irresponsible and illegal. There are many diabetics around the country who were led to believe that Valturna would not only help lower their blood pressure, but it would also help treat their renal issues as well. The problem is that there is no real scientific evidence showing that the drug is safe for diabetics to use, or that it actually helps them with their renal problems.

Valturna ALTITUDE Clinical Trials

Novartis initiated the so-called ALTITUDE clinical trials to test the safety of diabetic usage with Valturna. Unfortunately, midway through the tests, the company realized that Valturna is not safe; indeed, it is dangerous. The ALTITUDE trials were subsequently suspended in December 2011 because of the high number of diabetics who suffered from strokes, renal problems and other issues during the tests.

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