Novartis is changing the product information for Rasilez, sold in the U.S. as Tekturna, to say that the drug should not be used to treat patients with diabetes or kidney problems who are taking certain other medicines.
The drugmaker is also complying with a recommendation of
the European Medicines Agency that the label include a warning
against combining products containing aliskiren, the active
ingredient in Rasilez, with heart drugs known as ACE inhibitors
or ARBs, the agency said today in an e-mailed statement.
Novartis halted a trial of the drug in December after it was
linked to increased risk of stroke and kidney problems.