FDA slaps warning on using aliskiren with ACEIs, ARBs
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In addition, a new warning is being added to avoid use of these drug combinations in patients with kidney impairment. The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints).
The following recommendations are being added to the drug labels for aliskiren-containing products as of April 20:
- A new contraindication against the use of aliskiren with ARBs or ACEIs in patients with diabetes because of the risk of renal impairment, hypotension and hyperkalemia.
- A warning to avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate is less than 60 mL/min).
In ALTITUDE, the risks of renal impairment, hypotension and high potassium blood levels (hyperkalemia) in a group of patients taking aliskiren plus an ARB or ACEI increased relative to a group of patients taking placebo plus an ARB or ACEI. The preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (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.
In February 2009, the European Medicines Agency recommended adding a contraindication to the product information of Novartis' aliskiren (sold as Rasilez in the EU, Tekturna in the U.S.), indicating that it should not be used in patients who have experienced angioedema when taking the hypertension drug.
The agency said it 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 complete FDA Drug Safety Communication is available on its website.