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aliskiren/valsartan FDA Alerts

The FDA Alert(s) below may be specifically about aliskiren/valsartan or relate to a group or class of drugs which include aliskiren/valsartan.

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/valsartan

Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication

Apr 20, 2012

Audience: Internal Medicine, Pharmacy, Endocrinology

including:

  • 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

 

[Posted 04/20/2012]

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:

 

[04/20/2012 - Drug Safety Communication - FDA]

Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed

Jun 2, 2011

Audience: Cardiology, Oncology, Family Practice

[UPDATED 06/02/2011] FDA’s meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs.

 

[Posted 07/15/2010]

ISSUE: A recently published study - a meta-analysis combining cancer-related findings from several clinical trials - suggested use of ARBs may be associated with a small increased risk of cancer.

BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.

The meta-analysis included data from over 60,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. The mean duration of follow-up ranged from 1.7 to 4.8 years.

The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). No statistically significant difference in cancer deaths was noted.

RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks.

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:


[06/02/2011 - Drug Safety Communication - FDA]
[07/15/2010 - Drug Safety Communication - FDA]