Letter to health care professionals regarding the new contraindications and warnings for the use of medicinal products containing aliskiren in combination with angiotensin converting enzyme inhibitors or angiotensin receptor blockers


The company Novartis Hrvatska d.o.o., marketing authorisation holder for the medicinal product Rasilez (aliskiren) and Rasilez HCT (aliskiren + hydrochlorothiazide), in cooperation with the Agency for Medicinal Products and Medical Devices (HALMED), has sent a letter to health care professionals regarding new safety information for aliskiren. Medicinal products containing aliskiren have been approved for the treatment of essential hypertension (increased blood pressure without known cause).

Previously, HALMED issued a statement in December 2011 (in Croatian) regarding the potential risks of harmful cardiovascular and renal events in patients with type II diabetes and kidney damage and/or cardiovascular disease. For that reason, a letter has been sent to health care professionals (in Croatian) with interim therapy recommendations. Through this letter, physicians are informed of the new prescription recommendations and revision of therapy for patients taking medicinal productions containing aliskiren.

Prescription recommendations:

  • Medicinal products containing aliskiren are contraindicated in combination with angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) in patients with diabetes mellitus (Type I or type II) or kidney damage (GFR < 60 ml/min/1.73 m2).
  • For all other patients, it is not recommended that medicinal products containing aliskiren be used in combination with ACE inhibitors or ARB.

Recommendations for routine (not urgent) therapy revision:

  • Health care professionals should terminate treatment based on aliskiren and should not begin new therapy with aliskiren in patients taking an ACE inhibitor or ARB and who have diabetes mellitus or kidney damage (GFR < 60/ml/min/1.73m2). Consider a different antihypertensive therapy as needed.
  • In other patients taking medicinal products containing aliskiren simultaneously with an ACE inhibitor or ARB, the benefit to risk ratio of continuing therapy should be carefully considered.

The Letter to Health Care Professionals can be viewed here (in Croatian).

HALMED has not yet received any reports of adverse reactions to the medicinal products Rasilez or Rasilez HCT. HALMED will continue to monitor the safe use of aliskiren and will inform the public of all new information in a timely manner.

We would like to remind all health care professionals that they are obliged to report every adverse reaction to HALMED. Patients developing an adverse reaction to a medicinal product may also report the adverse reaction directly to HALMED, with the recommendation that they contact their doctor or pharmacist regarding the adverse reactions and regarding the continuation of therapy.