Aliskiren-Containing Blood Pressure Medications
April 23, 2012
FDA is issuing warnings that concomitant administration of medications containing aliskiren with angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) are contraindicated in patients with diabetes due to increased risk of hypotension, hyperkalemia, and renal impairment. FDA is also warning to not use this combination in patients with moderate to severe renal impairment (glomerular filtration rate less than 60 mL/min). Aliskiren is a medication labeled to treat hypertension. Brand name medications containing aliskiren include Amturnide, Tekturna, Tekturna HCT, Tekamlo, and Valturna.
The ALTITUDE clinical trial enrolled patients with type 2 diabetes and renal impairment to receive either aliskiren 300 mg once daily (n=4283) or placebo (n=4296) in combination with an ACEI or ARB. According to preliminary data, patients in the aliskiren group have an increased risk of hypotension, hyperkalemia, and renal impairment, compared to patients taking placebo and an ACEI or ARB. A numerical increase in the risk of stroke and death was also observed with aliskiren, however FDA has not made any conclusions and will evaluate the final data once it becomes available. Further details on the ALTITUDE trial as well as a complete list of FDA approved ACEI and ARBs are available through the FDA Drug Safety Communication link below.
Educate patients to contact their healthcare provider before discontinuing aliskiren or aliskiren-containing products. Do not use in patients with diabetes or patients with moderate to severe renal impairment.
Additional information is available at the following links:
- Medwatch Alert:
- FDA Drug Safety Communication:
April 23, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.