Combination of Tekturna, Other Hypertension Drugs Gets FDA Warning

Federal health officials warn that the blood pressure drug Tekturna and similar medications should not be given to diabetics or patients with kidney problems in combination with drugs known as ARBs and ACE inhibitors, which are also used to treat blood pressure problems. 

The combination of Tekturna and other drugs containing the active ingredient aliskiren with angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) can cause kidney impairment, hypotension and hyperkalemia, the FDA warned in a drug safety communication issued on April 20.

The announcement has led Novartis, which manufacturers aliskiren-containing drugs, to announce that it will phase out the drug Valturna, which is a combination of Tekturna and the ARB drug valsartan. Valturna will be available through July before it is permanently removed from the market.

Tekturna (aliskiren) is manufactured by Novartis and was first approved in the United States in 2007 for the treatment of hypertension. Other drugs that contain aliskiren include Amturnide and Tekamlo. There were about 2.4 million prescriptions filled for aliskiren-containing drugs in 2011 in the United States, according to the FDA.

The warnings include a contraindication for the combination of drugs in the treatment of patients with diabetes and a warning against its use for patients who have already have moderate to severe kidney problems.

The FDA called for patients to continue using the drugs at least until they talk to their doctor and to make sure their health care professionals know if they are taking any ACEIs or ARBs at the same time they are prescribed a drug containing aliskiren.

The FDA warning came after a preliminary review of a study called ALTITUDE, which was ended early due to the high rates of kidney problems, hypotension and hyperkalemia observed among test subjects. The ALTITUDE trial involved the use of Tekturna along with ACE inhibitors or ARBs. As a result, Novartis says it will cease promoting the use of Tekturna in combination with those drugs in any patients, in addition to the phase out of Valturna.