Your Olmesar Side Effect submission can play a very important role. Reporting your experience could help identify an unknown risk and inform other patients and health care professionals.
How Can Olmesar Affect You?
|patient, weighting 119.0 lb, was diagnosed with chronic obstructive pulmonary disease and took Olmesar 20 Mg, Qd . Find Olmesar Side Effects and Adverse Events reported to FDA.|
View Olmesar Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)
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Did You Have a Olmesar Side Effect?
How Effective is Olmesar for You?
Active Ingredient: AMLODIPIN HYDROCHLO OLMESARTA
Side Effects reported to FDA: 1056. View Olmesar Adverse Reports
Reported deaths: 64
Reported hospitalizations: 544
Benicar (olmesartan): Ongoing Safety Review
[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.
Audience: Cardiology, Internal Medicine
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. Additional information about ROADMAP and ORIENT can be found at clinicaltrials.gov.
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:
Have Your experienced Olmesar Side Effects? You are not alone. Many patients report unusual symptoms after using Olmesar. PatientsVille.com raises awareness about Drug Side Effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.