Pearse Doherty (Donegal South West, Sinn Fein)
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To ask the Minister for Health if he has any concerns with respect to the drug rasilez aliskiren, if he is aware of other countries that have outlawed the drug; and if he will make a statement on the matter. [37685/12]

Róisín Shortall (Dublin North West, Labour)
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Aliskiren (trade name Rasilez) is used to treat hypertension (high blood pressure) in adults. Rasilez is licensed in all EU Member States and is only available on prescription.

A multinational study carried out in 2011 (ALTITUDE) to investigate aliskiren in a specific population of patients with type 2 diabetes and renal impairment found that aliskiren, when taken in combination with other blood pressure lowering medicines (ACE Inhibitors [ACEIs] or Angiotensin Receptor Blockers [ARBs], was associated with an increased risk of cardiovascular and renal events. Following a review of this and other data,the European Medicines Agency recommended that the use of aliskiren with these medicines be contraindicated in patients with diabetes mellitus or with moderate to severe kidney failure and that warnings should also be included recommending against the use of aliskiren with these medicines in general.The licence for aliskiren (Rasilez) has not been revoked and it continues to be available in all EU Member States subject to the updating of the prescribing information. Healthcare professionals are aware of the updated information and any patient who has concerns should consult their doctor in the first instance.