The action was basedonthe recommendation of the independent DataMonitoring Committee (DMC), after it found an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after 18-24 months.
The report was basedondata collected by the National Antimicrobial Resistance Monitoring System, (NARMS) a project sponsored by the Food and Drug Administration (FDA), the Centers for Disease Control and the U.S. Department of Agriculture.