FDA Drug Safety Communication: New Warning
and Contraindication for blood pressure medicines containing
aliskiren (Tekturna)
Safety Announcement
Additional
Information for Patients
Additional
Information for Healthcare Professionals
Data
Summary
Safety
Announcement
[4-20-2012] The U.S. Food and Drug
Administration (FDA) is warning of possible risks when using blood
pressure medicines containing aliskiren with other drugs called
angiotensin converting enzyme inhibitors (ACEIs) and angiotensin
receptor blockers (ARBs) in patients with diabetes or kidney
(renal) impairment. These drug combinations should not be used (are
contraindicated) in patients with diabetes. 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, “Aliskiren
Trial in Type 2 Diabetes Using Cardio-Renal Endpoints
(ALTITUDE).”
A list of medicines containing aliskiren is found in the Drug
Facts box. Lists of approved ACEIs and ARBs are found in
Tables 2 and 3.
In ALTITUDE, the risks of kidney (renal) impairment, low blood
pressure (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 [see Data
Summary]; 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 as of 4/20/12:
- 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 [GFR] < 60 mL/min).
Facts about
aliskiren-containing products
|
SOURCE