EMEA recommends new contraindication for aliskiren (Rasilez): angioedema

According to the EMEA, aliskiren (Rasilez, Tekturna in the USA) should not be prescribed in patients that experienced angioedema after taking the drug. Some excerpts from the EMEA press release dated 19 February, 2009:

The European Medicines Agency (EMEA) has recommended adding a contraindication to the Product Information for aliskiren, stating that it must not be used in patients who have experienced angioedema (swelling of the tissues beneath the skin) when taking aliskiren in the past. The Agency also recommended the inclusion of a warning, stating that patients who develop signs of angioedema should stop treatment and seek medical attention.

The Committee is therefore recommending that:

  • healthcare professionals should not prescribe any aliskiren-containing medicines for patients who have developed angioedema with the aliskiren-containing medicine in the past;
  • any patients who develop signs of angioedema should stop aliskiren treatment promptly and seek medical attention.

Meanwhile, the Scottish Medicines Consortium does not recommend aliskiren for essential hypertension.

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