Antihypertensive Drug Gets New FDA Warnings

Aliskiren-containing medications-including Amturnide, Tekturna, Tektuma HCT, Teamlo, and Valturna-are direct renin inhibiters used to treat hypertension. These drugs work by decreasing chemicals that cause the blood vessels to tighten. Often these drugs are used in combination with angiostensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). Recently, the Federal Drug Administration (FDA) has reported that these drug combinations can cause problems and should not be used in patients with diabetes or moderate to severe renal impairments.

The warnings came from preliminary data from the ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) clinical trial. ALTITUDE was terminated in December 2011 after it was found that certain patients had an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension. These complications arose in patients who also had diabetes or renal disease. In a letter to healthcare professionals, Novartis released the FDA warnings about aliskiren and the ALTITUDE clinical trial.

Novartis, a pharmaceutical company that makes aliskiren-based products, has voluntarily recalled ValturnaR, which is a single pill combination of aliskiren and ARB valsartan and only available in the United States. Novartis similarly decided to withdraw the same combination pill in Switzerland, which was marketed under the brand name RasivalR. Other Aliskiren-contaning pharmaceuticals remain on the market. In fact, Novartis announced on April 19 that it would continue to market such products.

Patients who have either diabetes or moderate to severe renal failure have been advised by Novartis to seek guidance from their healthcare professional. The FDA cautions that stopping aliskiren suddenly can cause problems if the patient’s high blood pressure is not otherwise treated.

If you or someone you know has been harmed by a medication, contact the attorneys at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling (713) 222-7211 or 713-222-7211.