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Novartis Agrees to New Rasilez Warnings in Europe

Filed February 20th, 2012 Julie

Novartis AG will add a warning to the label of the drug Rasilez in Europe in order to please regulators.

Rasilez, sold as Tekturna in the US, is prescribed to treat high blood pressure. Novartis is changing product information for the medication to reflect that it should not be used to treat patients who suffer from diabetes or kidney problems, or who are taking other medications.

Novartis is also complying with the European Medicines Agency’s recommendation to include a warning on Rasilez’s label against combining drugs containing aliskiren, the active ingredient in Rasilez with ACE inhibitors, which are heart drugs. The company put a stop to a trial of Rasilez in December when research revealed it was linked to an increased risk of stroke and kidney problems.

Today, the drug maker said it had written to doctors around the globe recommending that they do not prescribe Rasilez to treat people with Type 2 diabetes if they are also taking an ACE inhibitor. They are currently engaged in discussions with the US Food and Drug Administration about the use of the drug.

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