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Azor FDA Alerts

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

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 amlodipine/olmesartan

Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive

Jun 24, 2014

Audience: Cardiology, Pharmacy, Family Practice, Endocrinology

Includes: Benicar, Benicar HCT, Azor, Tribenzor, and Generics

[Posted 06/24/2014]

ISSUE: FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients (see previous alerts linked below). FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.

BACKGROUND: FDA safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients.

RECOMMENDATION: Patients should not stop taking olmesartan or any blood pressure medication without first discussing it with their health care professional. Recommendations for use of olmesartan remain the same, but FDA will require information about some of the studies to be included in the drug labels.

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.fda.gov/MedWatch/report.htm
  • 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


[06/24/2014 - Drug Safety Communication - FDA]

Olmesartan Medoxomil: Drug Safety Communication - Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy)

Jul 3, 2013

Audience: Health Professional, Cardiology, Patient

ISSUE: FDA is warning that the blood pressure drug Olmesartan Medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. FDA has approved changes to the labels of these drugs to include this concern. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan. 

FDA will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available.

BACKGROUND: Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs. 

RECOMMENDATION: Health care professionals should tell patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if it takes months to years for symptoms to develop. Patients should contact their health care professional right away if they take an olmesartan-containing product and experience severe diarrhea, diarrhea that does not go away, or significant weight loss.

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.fda.gov/MedWatch/report.htm
  • 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

[07/03/2013 - 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:

  • Online: www.fda.gov/MedWatch/report.htm
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
  • Fax: 1-800-FDA-0178


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

Benicar (olmesartan): Ongoing Safety Review

Apr 14, 2011

Audience: Cardiology, Internal Medicine

[UPDATED 04/14/2011] After reviewing the results of the ROADMAP and ORIENT trials, FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Benicar is not recommended as a treatment to delay or prevent protein in the urine (microalbuminuria) in diabetic patients.

Patients should consult their healthcare professional if they have any questions or concerns about taking Benicar.

Daiichi Sankyo, the makers of Benicar, have agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain more complete information about the cardiovascular risks or benefits of Benicar in various clinical settings. FDA will update the public when new information is available.

 

[Posted 06/11/2010]

ISSUE: FDA is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan), an angiotensin II receptor blocker, had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. FDA's review is ongoing and the Agency has not concluded that Benicar increases the risk of death. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.

BACKGROUND: The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar. ROADMAP and ORIENT are both long-term clinical trials. In both trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death, or stroke) in the Benicar-treated patients compared to placebo.

RECOMMENDATION: Follow the recommendations in the drug label when prescribing Benicar. Additional Information for Patients, for Healthcare Professionals and a Data Summary are provided in the Drug Safety Communication below..

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.

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