aliskiren/amlodipine/hydrochlorothiazide FDA Alerts
The FDA Alert(s) below may be specifically about aliskiren/amlodipine/hydrochlorothiazide or relate to a group or class of drugs which include aliskiren/amlodipine/hydrochlorothiazide.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for aliskiren/amlodipine/hydrochlorothiazide
Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication
Apr 20, 2012
Audience: Internal Medicine, Pharmacy, Endocrinology
- Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
- Tekturna (aliskiren hemifumarate)
- Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
- Tekamlo (aliskiren hemifumarate and amlodipine besylate)
- Valturna (aliskiren hemifumarate and valsartan). Valturna will no longer be marketed after July 2012
ISSUE: FDA notified healthcare professionals 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, 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). 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).”
BACKGROUND: Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.
RECOMMENDATION: Concomitant use of aliskiren with ARBs or ACEIs in patients with diabetes is contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia. Avoid use of aliskiren with ARBs or ACEIs in patients with renal impairment where GFR < 60 mL/min. Patients should not stop taking aliskiren without talking to your healthcare professional. Stopping aliskiren suddenly can cause problems if your high blood pressure (hypertension) is not treated.
See the Drug Safety Communication for the Data Summary, a list of ACEI and ARB products, and additional recommendations for healthcare professionals and patients.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[04/20/2012 - Drug Safety Communication - FDA]