No Longer Accepting Cases

A new study has found evidence that Valturna may significantly increase a patient’s risk of stroke, dangerously low blood pressure, and toxically high levels of potassium (“hyperkalemia”) which can cause kidney damage, kidney failure, and irregular heartbeat that can cause sudden cardiac arrest and death.

UPDATE: Valturna Withdrawn from U.S. Market

April 19, 2012 — Novartis announced today that thne company will voluntarily withdraw Valturna from the U.S. marketplace. The company had already ceased marketing of Valturna and recommended that physicians should not prescribe Valturna.

Overview

Valturna (aliskiren and valsartan) is a drug that is prescribed to people who suffer from high blood pressure, also known as “hypertension.” Valsartan combines two medications:

  • Aliskiren, the active medication in Tekturna. It belongs to a class of medications called direct renin inhibitors (DRIs), which inhibit renin, a natural substance that is involved in the constriction and narrowing of blood vessels. When renin is inhibited, the blood vessels are unable to constrict, which lowers blood pressure.
  • Valsartan, the active medication in Diovan. Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs), which inhibit angiotensin. Like renin, angiotensin is involved in the biological process where blood vessels constrict. By inhibiting angiotensin, Valsartan lowers blood pressure.

ALTITUDE Clinical Trial Ended Prematurely

When Novartis initiated the ALTITUDE clinical trial, they hoped to find that aliskiren could benefit Type-2 Diabetics who were at high risk of cardiovascular events and renal problems.

Instead, they found that people who had taken aliskiren for 18-24 months had a significantly higher risk of stroke, renal disorders, dangerously high potassium in the bloodstream (hyperkalemia), and low blood pressure.

After finding these results, Novartis prematurely ended the study. They also recommended that people should not take aliskiren combined with an ACE inhibitor or an ARB. Unfortunately, Valturna is a combination of aliskiren and an ARB. Following the results of this study, Novartis ceased all promotion of Valturna and recommended that doctors not prescribe it anymore and switch current patients to another treatment.

Valturna Kidney Problems

People who take Valturna have a high risk of developing hyperkalemia. This condition is caused by elevated levels of potassium in the bloodstream. Experts believe that one side effect of aliskiren is that it inhibits the normal excretion of potassium in the urine. As a person continues taking the medication, potassium levels get higher and higher. If untreated, potassium can actually reach toxic, life-threatening levels.

One reason why hyperkalemia is life-threatening is because it is under-diagnosed. A doctor must perform a blood test, but the initial symptoms are not very severe. Muscle weakness, general fatigue, and heart palpitations are relatively minor symptoms. However, hyperkalemia can cause irregular heartbeat, which can cause sudden death.

Valturna and Stoke

Valturna was linked to a higher risk of stroke in the ALTITUDE study. This is one of the most severe side effects of using Valturna. A stroke can potentially cause lifelong disability, injury, and death. Stroke can be caused by sudden bleeding in the brain (hemorrhagic stroke) or a blood clot that forms in the body, is pumped to the brain, and becomes trapped in a vessel (ischemic stroke). The symptoms of a stroke depend on what part of the brain is affected. They can occur suddenly, or off and on, growing slowly worse over several days.