Tekamlo Lawsuit

Tekamlo (aliskiren and amlopidine) is a prescription medication used to treat high blood pressure. It works by inhibiting substances that normally cause blood vessels to constrict and cause high blood pressure. Unfortunately, a recent clinical study of aliskiren had to be suddenly halted when researchers found a higher risk of strokes, kidney disease, dangerously low blood pressure, and a condition called “hyperkalemia” that can cause high levels of potassium in the bloodstream, irregular heartbeat, and sudden death.

UPDATE: New Warnings on Tekamlo Label

April 20, 2012 –The U.S. Food and Drug Administration (FDA) announced today that the labels on Tekamlo and other aliskiren-containing drugs will be updated to include new risk information. In a Drug Safety Communication, the FDA warned doctors that Tekamlo can cause kidney problems, dangerous low blood pressure (hypotension), or dangerously high levels of potassium in the bloodstream (hyperkalemia). The FDA advised doctors not to prescribe Tekamlo with an ARB or ACE inhibitor to people with diabetes or kidney problems.

Tekamlo Overview

Tekamlo is a combination medication used to treat high blood pressure, a condition also known as “hypertension.” It is manufactured by the pharmaceutical drug company Novartis, and was approved by the U.S. Food and Drug Administration (FDA) in August 2010.

Tekamlo contains the following active drugs:

• Aliskiren: Sold alone under the brand-name Tekturna. 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 the two medications were combined together, they were able to reduce blood pressure more effectively than either medication alone. Because around 85% of people with high blood pressure need to take multiple medications to control their high blood pressure, there is a need for effective combination medications. It is estimated that about one billion people globally suffer from high blood pressure, and many of these are not receiving adequate treatment. High blood pressure can increase the risk of heart attack and stroke. It can also cause organ damage to the heart, brain, and kidneys.

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

Tekamlo and the ALTITUDE Clinical Trial

On December 20, 2011, the ALTITUDE study was terminated early by Novartis

The researchers conducting the ALTITUDE clinical trial were hoping that people with Type-2 diabetes and high blood pressure who were at high risk of cardiovascular/renal diseases might benefit from long-term use of aliskiren (18-24 months). The study split patients into two groups — one taking aliskiren, and one taking a placebo. Unfortunately, when an independent safety committee reviewed preliminary data, they found that the group taking aliskiren had a significantly higher risk of stroke, renal complications, hyperkalemia, and low blood pressure. Novartis decided to immediately suspend the study and review the new safety concerns.

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). Unfortunately, because 85% of people with high blood pressure take a combination medication, the number of people who could safely use one of Novartis’s drugs is very small.

Tekamlo Recall

Tekamlo has not been recalled, but it is possible that Novartis will issue a Tekamlo recall in the future. Following the results of the ALTITUDE study, it appears that many people who take these medications have a higher risk of severe side effects, including stroke. Novartis is currently in talks with worldwide health authorities regarding the future of its medications.

So far, no health organization has ordered a recall of the medications. However, in February 2012, European health authorities mandated that Novartis update the safety labeling on Rasilez. Rasilez is the European version of Tekturna, which contains aliskiren as its primary ingredient. The new safety warnings will recommend that people who have diabetes or kidney problems should not combine aliskiren with an ACE inhibitor or an ARB.

Tekamlo and Stroke

People who take Tekturna have a higher risk of stroke. Though the stroke events in the ALTITUDE study were non-fatal, all strokes have the potential to be fatal, and they 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 is 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, which reduces the body’s ability to excrete potassium in the urine, which can lead to excessively high amounts of potassium in the bloodstream. This is a life-threatening condition, made even more dangerous due to the fact that hyperkalemia is difficult to diagnose. The first symptoms are relatively mild. Muscle weakness, heart palpitations, and malaise are the first signs, but 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.