FDA Issues New Warning Label for Tekturna

The U.S. Food and Drug Administration issued new warning labels for blood pressure drugs containing aliskiren—such as Tekturna, Tekamlo, Valturna, and Amturnide—as well as other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with kidney impairment or diabetes.

The drug labels are being updated following preliminary information from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).” The information also showed a slight excess of cardiovascular events (death or stroke) in the aliskiren group, but at this time, the FDA has not reached a definite conclusion in regards to an actual link between these drugs and death or stroke.

The agency said that it will communicate any new information when it becomes available as well as evaluate the final trial results and outcomes from other aliskiren trials.

Last year, about 2.4 million prescriptions for aliskiren-containing products were prescribed to 451,000 patients from U.S. outpatient retail pharmacies.

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