CHMP asks for angioedema warning on aliskiren label

The European Medicines Agency (EMEA) has recommended adding a contra-indication to the Product Information leaflet for Swiss drug  major Novartis' Tekturna (aliskiren), stating that it must not be used  in patients who have experienced angioedema when taking the blood  pressure drug in the past.

The Agency also recommended the inclusion of a warning, stating that  those who develop signs of angioedema should stop treatment and seek  medical attention. Aliskiren is authorized for the therapy of essential  hypertension (high blood pressure with no identifiable cause).

It has been cleared in the European Union since August 2007 as Rasilez,  Enviage, Sprimeo, Tekturna and Riprazo. Angioedema is characterized by  swelling of the skin, the tissues below the skin and the moist body  surfaces such as the lining of the mouth and throat. It can develop  rapidly and, in rare cases, can be dangerous if it affects the throat,  because it can lead to obstruction of the airway.