EMA says risk-benefit of ARBs positive; acts on Advagraf and Protelos/Osseor

21 October 2011

In a flurry of late news yesterday from the European Medicines Agency and its Committee for Medicinal Products for Human Use (CHMP), the advisory group said it has reviewed the possible link between the use of angiotensin II receptor antagonists (ARBs) and the occurrence of new cancers, concluding that the evidence does not support any increased risk of cancer in patients using these medicines.

Angiotensin II receptor antagonists have been authorized in the European Union since the mid-1990s for the treatment of hypertension. They are also used in the treatment of conditions such as heart failure and kidney disease in type 2 diabetes and for the prevention of strokes and heart disease.

The review was formally requested by the Italian Medicines Agency following the publication of a meta-analysis which showed a small increased risk of new cancers (particularly lung cancer) with ARBs compared with placebo and other heart medicines (7.2% versus 6%).

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