British Doctors, Patients Warned of Alkisiren (Rasilez, Tekturna) Dangers

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Health regulators in the U.K. have warned about the potential dangers of combining the blood pressure drug aliskiren with either ACE inhibitors or angiotensin receptor blockers (ARBs) due to the risk of heart and kidney complications.

According to a release from the Medical Healthcare Regulatory Agency (MHRA) in the U.K., the results of a large-scale clinical trial of aliskiren (sold in the U.S. under the brand name Tekturna and in the U.K. as Rasilez) has prompted the warning. The ALTITUDE clinical trial of Tekturna was investigating the potential dangers of the drug and its effectiveness in preventing future damage to the heart and kidneys when taken in a long-term manner.

Tekturna is approved to treat hypertension in the U.S. It has been the subject of a growing number of lawsuits from people claiming to have suffered serious side effects while taking it, including stroke, heart attack, acute kidney failure, hyperkalemia, and hypertension.

MHRA has advised against prescribing the combination of Tekturna and ACE inhibitors and ARBs, especially to diabetics (suffering from either Type 1 or Type 2 diabetes) and to people with a lower “glomerular filtration rate.” A patient suffering from any degree of renal impairment should also not be prescribed this combination of drugs.

In December, the ALTITUDE study was halted due to a higher-than-expected number of side effects reported among participants, including incidents of renal failure and non-fatal strokes. At the time, researchers were able to determine Tekturna had no positive impact for those treatments when combined with the other drugs.

Tekturna Information:

Aliskarin is sold alone and in the following combination products:

Amturnide (containing Amlodipine, Hydrochlorothiazide, and Aliskiren)
Tekamlo 150/10 (containing Amlodipine and Aliskiren)
Tekamlo 150/5 (containing Amlodipine and Aliskiren)
Tekamlo 300/10 (containing Amlodipine and Aliskiren)
Tekamlo 300/5 (containing Amlodipine and Aliskiren)
Tekturna HCT 150/12.5 (containing Hydrochlorothiazide and Aliskiren)
Tekturna HCT 150/25 (containing Hydrochlorothiazide and Aliskiren)
Tekturna HCT 300/12.5 (containing Hydrochlorothiazide and Aliskiren)
Tekturna HCT 300/25 (containing Hydrochlorothiazide and Aliskiren)
Valturna (containing Aliskiren and valsartan)

Possible Tekturna side effect include:

  • Strokes (a/k/a cerebrovascular accident (CVA) – rapid loss of brain function(s) due to disturbance in the blood supply to the brain i.e. bleed)
  • Heart attacks
  • Acute rental failure and other rental complications (renal = kidney)
  • Hyperkalemia (kidneys not functioning adequately)
  • Hypotension (abnormally low blood pressure)
  • Syncope (loss of consciousness)

Tekturna and other aliskiren products are contraindicated in:

  • Diabetic patients (type I & type II)
  • Non-diabetic patients whose Glomerular Filtration Rate (GFR) is <60ml (GFR tells how much kidney function you have. It may be estimated from your blood level of creatinine
  • Patients taking an ACE inhibitor (Angiotensin-Converting Enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
  • Patient taking an ARB (Angiotensin Receptor Blockers (primarily used for the treatment of hypertension where the patient is intolerant of ACE inhibitors)
  • Patient has severe renal impairment