Novartis AG said it will add a warning to the label for its blood-pressure drug Rasilez in Europe to comply with a request from regulators.
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 Basel, Switzerland-based company said in a statement today.
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.
Novartis said in January it expects that Tekturna sales in 2012 will be less than half of last year’s $557 million. The company booked a fourth-quarter charge of $900 million related to the lower forecast.
The company said today it has written to doctors worldwide recommending that patients with type 2 diabetes not be treated with products containing aliskiren if they’re also receiving an ACE inhibitor or ARB.
Novartis is in continuing discussions with the U.S. Food and Drug Administration over the use of the products, it said in the statement.