Novartis’ popular blood pressure drug Tekturna (generic: aliskiren) has recently been linked to a number of serious and potentially life-threatening side effects including strokes, kidney injuries, high potassium levels, and dangerously low blood pressure. In a recent study, type 2 diabetics who were treated with Tekturna were found to be far more likely to be diagnosed with these conditions than patients not treated with the drug. Aliskiren-containing blood pressure medications include Tekturna/TekturnaHCT, Valturna, Tekamlo, Amturnide, Rasilamlo, and Rasilez/Rasilez HCT.
What’s the problem with Tekturna?
Manufactured and marketed by Novartis Pharmaceuticals, Tekturna is an anti-hypersensitive blood pressure lowering medication designed to work by decreasing substances in the body that narrow blood vessels and raise blood pressure. First approved by the U.S. Food & Drug Administration (FDA) in 2007, Tekturna is prescribed as a treatment for hypertension (high blood pressure), either as monotherapy or in combination with other prescription drugs. Unfortunately, Tekturna has recently come under increased scrutiny because of its possible link to a number of extremely serious side effects and health complications.
Tekturna Side Effects
Serious side effects associated with Tekturna may include:
- kidney problems
- non-fatal strokes
- hyperkalemia (high potassium)
- hypotension (low blood pressure)
- renal complications
Other, less severe side effects commonly reported in Tekturna users include:
- slow, uneven heart rate
- weak pulse
- swelling around the eyes
- stomach pain or upset stomach
- itching skin
- skin rash
- back pain
- joint pain
- stuffy nose
- sore throat
A stroke occurs when a blood clot blocks an artery, or when a blood vessel breaks, interrupting blood flow to an area of the brain. When either of these things happen, brain cells begin to die and severe brain damage ensues. When cells in a particular region of the brain die, abilities controlled by that area of the brain are lost. Abilities typically affected by a stroke include speech, movement and memory. The degree of the stroke depends on where the event occurs and how much damage the brain has endured.
Signs and symptoms of a Tekturna-induced stroke may include:
- numbness on one side of the body
- loss of vision / problems with vision
- change in alertness
- sudden intense headache
Tekturna Kidney Injuries
On February 21, 2012, the European Medicines Agency (EMA) announced that it was calling for new kidney damage warnings for Tekturna and other similar drugs containing aliskiren. The EMA recommended that combinations of Tekturna with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) be contraindicated in individuals with diabetes or renal (kidney) impairment. European health regulators stated that the risks of Tekturna may outweigh any possible reward, and that patients in those situations seek other courses of treatment for controlling high blood pressure.
Signs and symptoms of Tekturna-induced kidney injury may include:
- metabolic acidosis (increased acidity of the body due to the inability to manufacture bicarbonate)
- inability to excrete potassium
- rising potassium levels in the serum (hyperkalemia)
- fatal heart rhythm disturbances (arrhythmias)
- ventricular tachycardia
- ventricular fibrillation
- rising urea levels in the blood (uremia)
- alteration of thinking
- inflammation of the heart lining (pericarditis)
- decreased muscle function because of low calcium levels (hypocalcemia)
- generalized weakness
- decreased red blood cell count
- loss of appetite
Tekturna ALTITUDE Clinical Trial Results
In December 2011, Novartis issued a press release stating that it had prematurely terminated its so-called ALTITUDE clinical study because a high number of test subjects suffered strokes, kidney injuries, and heart problems. The study involved nearly 9,000 patients treated with aliskiren from 36 countries. Blood pressure drugs containing aliskiren include:
- Tekturna (aliskiren)
- Tekturna HCT (hydrochlorothiazide and aliskiren)
- Valturna (aliskiren and valsartan)
- Tekamlo (aliskiren and amlodipine)
- Amturnide (aliskiren, amlodipine and hydrochlorothiazide)
- Rasilamlo (aliskiren and amlodipine)
- Rasilez (aliskiren)
- Rasilez HCT (hydrochlorothiazide and aliskiren)
Despite the fact that Tekturna has not been recalled in the United States or Europe, Novartis has stated that it is in the process of talks with worldwide health authorities about the implications of the ALTITUDE study. The company said that it would immediately halt promotion for aliskiren-containing medications until health authorities evaluate the findings. Following the announcement, one pharmaceutical industry analyst was quoted by Reuters as saying that the ALTITUDE study was a ‘major setback’ for Novartis, and that it could eventually lead to a nationwide Tekturna recall.
Tekturna & Pregnancy
If you are pregnant or planning to become pregnant, do not take Tekturna without consulting your doctor first. Tekturna has the potential to cause birth defects in an unborn baby if taken by the mother during pregnancy, especially during the last six months of gestation. Always be sure to use an effective form of birth control when taking Tekturna. Stop using the medication and tell your doctor immediately if you become pregnant during treatment.