Tekturna (Aliskiren) Associated with Serious Side Effects, Including Stroke, Severe Kidney Damage

Tekturna (aliskiren) and other medications containing aliskiren have been associated with serious side effects, including non-fatal stroke and severe kidney damage, in some patients. Tekturna and other aliskiren products were recently the subject of safety warnings in Europe (where it is sold as Rasilez), and Novartis has updated the product label there to include a warning against combining products containing aliskiren with heart drugs known as ACE inhibitors or angiotensin receptor blocker (ARB).

Tekturna Background

Tekturna was brought to market by Novartis in 2007, with hopes that it would become a blockbuster. It is approved as a treatment for hypertension (high blood pressure) either as monotherapy or in combination with another medication. Aliskiren is also available in combination products, including:

• 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)

Tekturna Side Effects

Possible Tekturna side effects include:

• Non-fatal strokes
• Heart attacks
• Acute kidney failure and other kidney complication
• Hyperkalemia, a condition caused by abnormally high levels of potassium in the blood
• Hypotension (abnormally low blood pressure)
• Syncope (loss of consciousness)

Halt of ALTITUDE Study

The ALTITUDE clinical trial was designed to evaluate the effect of aliskiren on the likelihood of cardiovascular and kidney events in high-risk diabetic patients. The more than 8,600 type-2 diabetes patients enrolled in ALTITUDE were treated with either aliskiren or a placebo, as well as whatever blood pressure medication they had been prescribed – either an ACE inhibitor or an ARB. The study was one of a number of large, costly trials Novartis funded in an attempt to broaden the use of Tekturna.

This past December, Novartis announced ALTITUDE had been halted after an independent review committee noted higher adverse events in patients receiving aliskiren in addition to standard of care in the trial. There was also an increased incidence after 18-24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia, and hypotension. As a precautionary measure, Novartis stopped promotion of the Tekturna and combination products containing aliskiren in combination with an ACE inhibitor or ARB in December.

European Regulatory Review of Aliskiren

The halt of the ALTITUDE study prompted the European Medicines Agency to launch a review of aliskarin medications. In January, Novartis agreed to a request from the European regulator to add new safety warnings to the labels of aliskiren products to reflect the findings of the ALTITUDE trial. Novartis also wrote to physicians world-wide recommending that patients with type 2 diabetes shouldn’t be treated with aliskiren, or combination products containing aliskiren, if they are also receiving an ACE inhibitor or ARB.

The European label for Rasilez and other aliskiren products now bears the following contraindications now states that they are contraindicated in:

• Diabetic patients (type 1 & type 2)
• 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 (primarily used for the treatment of hypertension where the patient is intolerant of ACE inhibitors)
• Patient has severe kidney impairment