The Wall Street Journal
(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
(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 (2/18, Miller) also covered the story.
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