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Tekturna Lawsuit

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Tekturna and Tekturna HCT (generic: aliskiren) are medications used to treat high blood pressure. Unfortunately, a recent clinical trial was ended prematurely after researchers linked these medications to severe, life-threatening side effects. Tekturna side effects may include kidney problems, strokes, hyperkalemia (high potassium), hypotension (low blood pressure), and more.

PATIENT SAFETY UPDATE

January 29, 2013 — U.S. launches federal probe into marketing of Tekturna and payments Novartis made to doctors. Click here to read more.

April 20, 2012 — The FDA has published a Drug Safety Communication to warn healthcare professionals about the possible risk of kidney impairment, dangerously low blood pressure (hypotension), and hyperkalemia (dangerously high levels of potassium). The FDA is specifically warning doctors not to prescribe Tekturna in combination with an ACE inhibitor or an ARB to patients who have diabetes or kidney problems. The labels on Tekturna will also be updated to include these new warnings.

December 20, 2011 — Novartis has decided to suspend promotion of Tekturna and Tekturna HCT after finding an increased risk of non-fatal stroke, renal complications, hyperkalemia, and hypotension in people with Type-2 diabetes who were taking Tekturna because they were at high risk of a cardiovascular or renal event. Novartis now recommends that patients should not take Tekturna or Tekturna HCT with other high blood pressure drugs, such as an ACE inhibitor or an ARB.

Tekturna Overview

Tekturna and Tekturna HCT are medications used to treat high blood-pressure. They are manufactured by the drug-company Novartis. These medications contain a drug called aliskiren, which was first approved by the U.S. Food and Drug Administration (FDA) in 2007 for the treatment of high blood pressure.

Aliskiren belongs to a class of drugs called direct renin inhibitors. These medications treat high blood pressure by inhibiting renin, an enzyme that is involved in the production of another compound called angiotensin I, which is then converted to angiotensin II, which causes blood vessels to constrict. When blood vessels become more narrow, the blood pressure inside these vessels increases. The overall effect of inhibiting renin is that blood vessels cannot constrict, which lowers blood pressure.

Several drugs that contain aliskiren are manufactured by Novartis. The Schmidt Firm, PLLC is currently accepting cases of severe, potentially life-threatening injuries caused by the following medications:

Tekturna and Kidney Problems

Tekturna has been linked to a serious kidney side effects known as hyperkalemia, a potentially life-threatening condition caused by high levels of potassium in the bloodstream. Tekturna may interfere with urinary excretion of potassium, leading to toxically high levels in the body. Hyperkalemia can be difficult to diagnose, because it requires a blood test. Initial symptoms may be no more severe than muscle weakness, heart palpitations, and malaise. Though the initial symptoms are benign, hyperkalemia can lead to sudden death from irregular heartbeat (cardiac arrhythmias).

In February 2012, Novartis announced that it will be updating the safety labeling on Rasilez (the European brand-name of Tekturna). The new safety labeling will warn that the drug should not be used to treat patients with diabetes or kidney problems who are already taking a high blood pressure medication (ARB or an ACE inhibitor).

Tekturna and Stroke

Tekturna was associated with an increased risk of non-fatal stroke during the ALTITUDE clinical trial. This side effect was one of the reasons why the trial was halted prematurely. Strokes can be caused by a blood clot that forms in the body and is pumped into the brain, called an ischemic stroke. If the blood clot becomes trapped in a vessel in the brain, this part of the brain becomes deprived of oxygen and can quickly die. Strokes can also be caused by bleeding in the brain, called a hemorrhagic stroke.

Symptoms will depend on what part of the brain is deprived of oxygen. Most commonly, symptoms appear suddenly. Sometimes they appear slowly, off and on, over several days.

Warning signs may include:

  • Headache
  • Muscle weakness, tingling, or numbness in the face, arm, leg, usually only on one side
  • Change in alertness (drowsiness, loss of consciousness, coma)
  • Changes in sensation (hearing, taste, touch)
  • Slurred speech
  • Blurry vision, loss of vision
  • Clumsy motor coordination; difficulty walking, writing, balancing, reading, swallowing
  • Confusion, loss of memory
  • Dizziness
  • Incontinence
  • Personality, mood, or emotional changes

Tekturna ALTITUDE Clinical Trial Results

December 20, 2011: ALTITUDE study terminated early by Novartis

The ALTITUDE trial was testing the effect of Tekturna in people who had Type-2 Diabetes who were at high risk of cardiovascular and renal events. After analyzing preliminary data, an independent Data Monitoring Committee (DMC) monitoring the ALTITUDE trial found an increased risk of non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients who had taken Tekturna for 18-24 months. The committee recommended stopping the trial because Tekturna was unlikely to show any benefit, and potential safety concerns had been identified.

In response, Novartis terminated the ALTITUDE study. Experts recommended that physicians not prescribe Tekturna with an ACE inhibitors or an ARB (two types of medications commonly used to treat high blood pressure). Experts also recommended that patients who are currently taking Tekturna in combination with one of these medications switch to an alternative treatment for their high blood pressure. The problem is that most people who suffer from high blood pressure are already taking an ACE inhibitor or an ARB, so the number of patients who could potentially take Tekturna is very small.

Tekturna Recall

Tekturna has not been recalled in the United States or Europe, despite results of the ALTITUDE clinical trial. This trial found that when Tekturna is combined with an ACE inhibitor or an ARB (common drugs prescribed for high blood pressure), patients are at high risk of severe side effects, including stroke. The number of people with high blood pressure who are not already taking an ACE inhibitor or ARB who would benefit from Tekturna is very small.

It is possible that there will be a Tekturna recall in the future. Novartis is currently conferring with medical health authorities regarding the implications of the ALTITUDE study. In the meantime, Novartis has halted promotion of this medication and alerted doctors of the results of the study. The results of this study are a major setback for Tekturna. It is possible that in the future, Novartis will decide to recall Tekturna.

Tekturna Side Effects

Potential side effects include, but are not limited to:

  • Cardiovascular events
  • Stroke
  • Irregular heartbeat (arrhythmia)
  • Renal injury
  • Kidney damage, or kidney failure
  • Hyperkalemia (significant increase in the amount of potassium in the bloodstream, which may cause irregular heartbeat, nausea, slow or weak pulse, and muscle weakness)
  • Low blood pressure (hypotension)

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