A recent clinical trial found that the aliskiren in Tekamlo could cause stroke, dangerously low blood pressure, kidney damage, and toxic high levels of potassium in the bloodstream (“hyperkalemia”).
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.
It is estimated that one billion people in the world have high blood pressure, also known as “hypertension.” This condition is caused when the smooth muscles lining the blood vessels are constricted and narrowed. This can cause a variety of life-threatening complications. The heart must work harder to pump blood, which increases a person’s risk of heart attack and stroke. High blood pressure can also damage internal organs, including the heart, brain, and kidneys.
This is why many people take a medication to lower their high blood pressure. One such medication is Tekamlo, created and sold by the pharmaceutical drug company Novartis. Tekamlo was approved by the U.S. Food and Drug Administration (FDA) in 2010 to reduce high blood pressure.
Tekamlo is actually a combination medication. Around 85% of people with high blood pressure use a combination medication. The medications in Tekamlo are:
- Aliskiren: This is the first, one type of medication called a Direct Renin Inhibitor (DRI), which works by inhibiting renin, a substance normally produced by the body that converts to Angiotensin I and II, which causes blood vessels to narrow. By inhibiting renin, aliskiren lowers blood pressure.
- Amlopidine: This widely-used medication is a calcium-channel blocker, which causes smooth muscles along the blood vessels to relax, thus lowering blood pressure.
Novartis manufactures several drugs that contain aliskiren. The Clark Firm, LLP 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
The controversy surrounding Tekamlo and aliskiren stems from one clinical trial that found an alarming rate of severe side effects. On December 20, 2011, Novartis terminated the ALTITUDE clinical trial. This trial was comparing aliskiren to a placebo in people who had Type-2 Diabetes and high blood pressure who were at high risk of a cardiovascular/renal event. The patients had all been taking aliskiren for 18-24 months.
An independent Data Monitoring Committee (DMC) was monitoring results of the study. When they reviewed preliminary data, they found alarming results — compared to the group on a placebo, the group taking aliskiren had a higher risk of non-fatal stroke, renal problems, low blood pressure, and dangerously high potassium in the bloodstream (hyperkalemia).
Novartis abruptly terminated the study. They also ceased all promotion of aliskiren-containing drugs, including Tekamlo. They recommended that doctors not prescribe an aliskiren-containing drug in combination with an ARB or ACE inhibitor (common medications used to treat high blood pressure). Since 85% of people with high blood pressure combine medications, the number of people who could safely use aliskiren is very small.
Tekamlo has not been recalled. No medical health authorities have ordered Tekamlo to be recalled, and Novartis has not voluntarily issued a Tekamlo recall. Even so, it is possible that there could be a recall of this medication in the future. The results of the ALTITUDE clinical study significantly limits the number of people who can take a medication containing aliskiren, because it shows that aliskiren should not be combined with an ARB or an ACE inhibitor.
So far, health authorities have only asked that Novartis update the drug safety labeling information. In February 2012, European health authorities ordered Novartis to update the labeling on Rasilez, which is the European version of Tekturna (aliskiren). The updated labeling will warn that people with diabetes or kidney problems should not combine aliskiren with an ACE inhibitor or an ARB, and 85% of people with high blood pressure take one of these medications.
Tekamlo and Stroke
Tekamlo was linked to an increased risk of stroke. Though, fortunately, the risk of stroke found in the ALTITUDE trial was non-fatal, strokes always have the potential to be life-threatening or debilitating. Strokes can cause brain damage in two ways: during a hemorrhagic stroke, a blood vessel bursts and there is severe bleeding in the brain. During an ischemic stroke, a blood clot becomes stuck in the brain and deprives brain tissue of the oxygen-rich blood it needs to survive. In all types of stroke, a person is at risk of permanent brain damage and death.
The first warning signs of a stroke may include:
- 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
- Personality, mood, or emotional changes
Tekamlo and Kidney Damage
Tekamlo contains aliskiren, which can cause damage to the kidneys. This can significantly reduce the body’s capacity to eliminate potassium from the bloodstream. Over time, potassium levels may grow to life-threatening, toxic levels in the bloodstream. This can cause a condition called hyperkalemia. If hyperkalemia is untreated or undiagnosed, 67% of people with it will die. It is actually relatively difficult to diagnose. The first symptoms are very mild, including malaise, heart palpitations, and general muscle weakness. However, hyperkalemia can cause irregular heartbeat that can cause sudden death.