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Friday, March 9, 2012

EMA Says Aliskiren Label Should Warn Of Potential Stroke, Kidney Problems.

The Wall Street Journal Share to FacebookShare to Twitter (2/18, Stovall, Subscription Publication) reported that the European Medicines Agency (EMA) said last week that Novartis AG's Rasilez (aliskiren) label would be required to warn of potential stroke and kidney trouble.
        Bloomberg News Share to FacebookShare to Twitter (2/18, Bennett) reported that Novartis "is also complying with a recommendation of the European Medicines Agency that the label include a warning against combining products containing aliskiren...with heart drugs known as ACE inhibitors or ARBs, the agency said...in an e-mailed statement." The drugmaker "is in continuing discussions with the US Food and Drug Administration over the use of the products, it said in the statement." The drug is "sold in the US as Tekturna." HeartWire Share to FacebookShare to Twitter (2/18, Miller) also covered the story.

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