The European Medicines Agency (EMA) has completed a review of aliskiren (Rasliez®) by recommending new contraindications and warnings. It is expected that prescribing information will be updated to reflect this new advice.
The ALTITUDE Study was recently stopped early due to a higher rate of adverse events occurring in the treated study participants. Initially, the EMA recommended against using aliskiren in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) in patients with diabetes.
This advice has now been extended to include a contraindication in patients with moderate to severe renal impairment and a warning that the combination of aliskiren and ACEI or ARB should be carefully considered in all other patients.
Action: Clinicians should be aware of this extended advice and implement any necessary change in practice. Patients should be reviewed where appropriate and alternative treatments considered.