The European Medicines Agency (EMEA) has recommended adding a contra-indication to the product information for Novartis' aliskiren (sold as Rasilez in the E.U., Tekturna in the U.S.), indicating that it should not be used in patients who have experienced angioedema when taking the hypertension drug.
The EMEA also recommended the inclusion of a warning stating that patients who develop signs of angioedema should stop treatment and seek medical attention.
Angioedema is characterised by swelling of the skin, the tissues below the skin and the moist body surfaces, such as the lining of the mouth and throat. According to the agency, the condition can develop rapidly and in rare cases can be dangerous if it affects the throat, because it can lead to obstruction of the airway.
Following assessment of the available evidence, the EMEA's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of aliskiren-containing medicines in the treatment of essential hypertension continue to outweigh their risks, but that angioedema can occur as a rare and serious side effect with these medicines.
The CHMP recommended that:
- Healthcare professionals should not prescribe any aliskiren-containing medicines for patients who have developed angioedema with the aliskiren-containing medicine in the past; and
- Any patients who develop signs of angioedema should stop aliskiren treatment promptly and seek medical attention.
The EMEA said its recommendations have been sent to the European Commission for the adoption of a legally binding decision.