Tekturna and Tekturna HCT are mediations used to treat high blood pressure. Unfortunately, new research has found that Tekturna side effects may include stroke, kidney damage, hyperkalemia (high potassium in the blood), low blood pressure, and more.
UPDATE: New Warnings on Tekturna Label
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 U.S. Food and Drug Administration (FDA) announced today that the labels on Tekturna, Tekturna HCT, and other aliskiren-containing drugs will be updated to include new risk information. In a Drug Safety Communication, the FDA warned doctors that Tekturna 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 Tekturna with an ARB or ACE inhibitor to people with diabetes or kidney problems.
Tekturna and Tekturna HCT are prescription medicines used to lower blood pressure. They are manufactured by the drug company Novartis. Both Tekturna and Tekturna HCT contain a drug called aliskiren, which belongs to a class of high blood pressure medications called direct renin inhbitors. As the name suggests, these medications inhibit renin, which is an enzyme in the body normally involved in the constriction of blood vessels. When renin is inhibited, blood vessels are unable to constrict, which has the effect of lowering blood pressure.
Aliskiren was first approved by the U.S. Food and Drug Administration (FDA) in 2007, and has since been used in a variety of medications. It can be used alone, as in Tekturna, or in combination with other blood pressure medications.
Novartis manufactures the following high blood pressure medications containing aliskaren:
- Tekturna (aliskiren)
- Tekturna HCT (aliskiren and hydrochlorothiazide)
- Valturna (aliskiren and valsartan, an ARB)
- Tekamlo (aliskiren and amlodipine)
- Amturnide (aliskiren and amlodipine besylate, hydrocholorothiazide)
Tekturna ALTITUDE Clinical Trial Results
December 20, 2011: ALTITUDE study terminated early by Novartis
The ALTITUDE clinical trial was looking at the effect of Tekturna in Type-2 diabetics who also had a high risk of suffering a cardiovascular event or renal problems. Patients were split into a group receiving Tekturna, and a group receiving a placebo. When an independent committee reviewed preliminary data, they found a higher risk of non-fatal stroke, renal problems, hyperkalemia (potentially life-threatening high potassium in the bloodstream), and low blood pressure among people who had used Tekturna for 18-24 months.
These high rates of side effects prompted Novartis to half the study prematurely. Furthermore, researchers advised that doctors should no longer prescribe Tekturna with certain types of high blood pressure medications called ACE inhibitors or ARBs. This significantly decreases the number of people who would benefit from using Tekturna, because most people who have high blood pressure already take an ACE inhibitor or an ARB.
Tekturna and Stroke
The ALTITUDE study linked Tekturna to a higher risk of stroke, which was one reason why the study was ended prematurely. There are two major types of strokes: ischemic strokes (caused by a blood clot being pumped into the brain and becoming trapped in the blood vessels) and a hemorrhagic stroke (caused by bleeding in the brain that kills brain tissue). Strokes can cause lifelong debilitation, disability, or death.
Symptoms of a stroke 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:
- 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
Tekturna and Kidney Damage
One side effect of Tekturna is a condition called hyperkalemia. This is caused by toxically high levels of potassium in the bloodstream. Experts believe that Tekturna inhibits the kidney excretion of potassium. Hyperkalemia is a very serious, life-threatening condition, and it is very dangerous because it is difficult to diagnose. The first symptoms are relatively benign, and include muscle weakness, heart palpitations, and general feelings of malaise. Unfortunately, it can quickly cause death via severe, irregular heartbeat (also known as “cardiac arrhythmias”).
Tekturna has not yet been recalled, but there may be a Tekturna recall in the future. Because the results of the ALTITUDE study significantly decrease the number of people who could safely use Tekturna, many medical health authorities are concerned about the future of the drug’s approval. In a statement issued to doctors, Novartis announced that it was currently engaging in talks with global health authorities. It is possible that these health authorities will recommend a Tekturna recall.
Until then, European health authorities have mandated that Novartis update the Warnings and Precautions labeling on Rasilez (the European brand-name of Tekturna). The new precautions will advise patients not to combine the medication with other medications used to treat high blood pressure, specifically ACE inhibitors or ARBs.
Tekturna Side Effects
Potential side effects include, but are not limited to:
- Cardiovascular events
- 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)