FDA Drug Safety Podcast for Healthcare Professionals: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna)
Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna).
Kim Wu, a pharmacist in the Division, will provide you with additional information about this Communication.
Guest Speaker: On April 20, 2012, the Food and Drug Administration issued a Drug Safety Communication warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (or ACE inhibitors) and angiotensin receptor blockers (or ARBs) in patients with diabetes or renal impairment. These drug combinations are contraindicated in patients with diabetes. In addition, a new warning is being added to avoid use of these drug combinations in patients with renal impairment. The labels for the aliskiren drugs are being updated based on preliminary data from the “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints” (or ALTITUDE) clinical trial.
In ALTITUDE, the risks of renal impairment, hypotension, and hyperkalemia in a group of patients taking aliskiren plus an ARB or ACE inhibitor increased relative to a group of patients taking placebo plus an ARB or ACE inhibitor. The preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (of death or stroke) in the aliskiren group; however, FDA has reached no definite conclusion regarding an actual link between these drugs and death or stroke. FDA will evaluate the final trial results as well as results from other aliskiren trials and will communicate any new information when it becomes available.
The following recommendations are being added to the drug labels for aliskiren-containing products:
- A new contraindication against the use of aliskiren with ARBs or ACE inhibitors in patients with diabetes because of the risk of renal impairment, hypotension, and hyperkalemia.
- A warning to avoid use of aliskiren with ARBs or ACE inhibitors in patients with moderate to severe renal impairment (i.e., where the glomerular filtration rate [or GFR] < 60 mL/min).
At this time FDA recommends that Healthcare Professionals be aware that:
- Concomitant use of aliskiren with ARBs or ACE inhibitors in patients with diabetes is contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia.
- Avoid use of aliskiren with ARBs or ACE inhibitors in patients with renal impairment where GFR < 60 mL/min.
- Valturna (a combination drug containing aliskiren and valsartan) should not be used in patients with diabetes. Additionally, Valturna will no longer be marketed after July 2012. For more information please visit the manufacturer’s website at www.novartis.com.
- FDA has not concluded that there is a link between these drugs and death or stroke from the preliminary findings from the ALTITUDE trial.
- Adverse events involving aliskiren should be reported to the FDA MedWatch program at www.fda.gov/medwatch.
Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, the complete Data Summary, and to the ALTITUDE trial can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at firstname.lastname@example.org.
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