Notice Information: - 3rd Party Publications - 17/02/2012

Title:

European Medicines Agency finalises review of aliskiren-containing medicines

Product:

Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Riprazo, Riprazo HCT, Sprimeo, Sprimeo HCT

Issue:

Following completion of its review of these products, the European Medicines Agency is recommending new contraindications and warnings for aliskiren-containing medicines.

It is recommending that these medicines should be contraindicated in patients with diabetes or moderate to severe renal impairment who take angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). In addition, the Agency recommended the inclusion of a warning that the combination of aliskiren and ACE inhibitor or ARB is not recommended in all other patients because adverse outcomes cannot be excluded.

Aliskiren-containing medicines are approved for the treatment of essential hypertension. ‘Essential’ means that there is no obvious cause for high blood pressure.

European Medicines Agency - press release