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Drugs Containing Aliskiren (Tekamlo) Are Proven Kidney Risk

by admin on April 25, 2012 in Defective Drugs

About Tekamlo

Tekamlo (aliskiren and amlopidine) is a prescription medication used to treat high blood pressure (hypertension). It works by inhibiting substances that normally cause blood vessels to constrict and cause high blood pressure.

It was approved by the FDA in August 2010 and is manufactured by Novartis.

Researchers halted a study of aliskiren, the generic name for the drug, after they found a higher risk of strokes, kidney disease, and dangerously low blood pressure (hyperkalemia).

Tekamlo Overview

Tekamlo contains the following active drugs:

  • Aliskiren: Aliskiren is the first and only FDA-approved direct renin inhibitor (DRI).

    Renin is a normal substance that causes blood vessels to constrict and narrow, causing high blood pressure. By inhibiting this substance, aliskiren lowers blood pressure.

  • Amlopidine: This is a widely-used calcium-channel blocker, which lowers blood pressure by relaxing the muscles in blood vessels.

When these two drugs were taken together, they were able to reduce blood pressure more effectively than either medication alone.

Around 85% of people with high blood pressure need to take multiple medications to control their high blood pressure.

Below are several brand name drugs manufactured by Novartis that contain aliskiren:

  • Tekturna (aliskiren)
  • Tekturna HCT (aliskiren and hydrochlorothiazide)
  • Valturna (aliskiren and valsartan, an ARB)
  • Tekamlo (aliskiren and amlodipine)
  • Amturnide (aliskiren and amlodipine besylate, hydrocholorothiazide)

Novartis and Tekamlo Study

After a study was conducted to determine the benefits of long-term use of aliskiren failed, Novartis decided to immediately suspend the study and review the safety concerns.

The results determined that one study group taking aliskiren had a significantly higher risk of stroke, renal complications, hyperkalemia, and low blood pressure.

Novartis decided to cease promotion of its products containing aliskiren, including Tekamlo.

The company also decided to recommend that doctors not prescribe this medication to people taking another blood pressure medication (specifically, an ARB or an ACE inhibitor).

Tekamlo and Stroke

People who take Tekturna have a higher risk of stroke. Though the stroke events in the study were non-fatal, all strokes have the potential to be fatal.

Strokes often cause severe, irreversible brain damage that results in permanent disability.

There are two major types of stroke:

Hemorrhagic stroke
Caused by a blood vessel that bursts and causes bleeding in the brain, which kills brain cells
Ischemic stroke
Caused by blood clots that travel to the brain, become stuck in a blood vessel, and block the supply of blood to a part of the brain

The first warning signs of a stroke 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

Tekamlo and Kidney Damage

One side effect of Tekamlo is a condition called hyperkalemia. It is thought that Tekamlo can cause hyperkalemia by causing kidney damage.

Kidney damage reduces the body’s ability to excrete potassium in the urine, which can lead to excessively high amounts of potassium in the bloodstream.

Initial symptoms include muscle weakness, heart palpitations, and malaise. However, they can quickly lead to irregular heartbeat and sudden death.

A doctor must run a blood test to diagnose hyperkalemia. When not diagnosed or treated, around 67% of people with hyperkalemia will die.

Tekamlo Lawsuit

If you or somebody you know has been injured by Tekamlo, contact us today. You may be eligible to receive compensation for your injuries through a defective drug lawsuit.

Call us toll-free 1-888-GARRETT (1-888-427-7388) or fill out our contact form for a free legal consultation.

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