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

Posted 24 Jun 2014 by Drugs.com

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 ... Read more

Related support groups: Diabetes, Type 2, Benicar, Azor, Benicar HCT, Olmesartan, Tribenzor, Amlodipine/hydrochlorothiazide/olmesartan, Hydrochlorothiazide/Olmesartan, Amlodipine/Olmesartan

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

Posted 3 Jul 2013 by Drugs.com

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 t ... Read more

Related support groups: High Blood Pressure, Hypertension, Benicar, Azor, Benicar HCT, Olmesartan, Tribenzor, Amlodipine/hydrochlorothiazide/olmesartan, Hydrochlorothiazide/Olmesartan, Amlodipine/Olmesartan

Fainting Spells Often Tied to Too Many Meds at Once: Study

Posted 4 Nov 2012 by Drugs.com

SUNDAY, Nov. 4 – Taking too many medications at the same time could lead to repeated fainting episodes, a new study reveals. "Simply stated, the more antihypertensive pills a patient takes, the greater the likelihood of a possible fainting spell under certain circumstances," explained one cardiologist, Dr. David Friedman, chief of Heart Failure Services at North Shore-LIJ's Plainview Hospital in Plainview, N.Y. He was not involved in the new research. In the study, Danish researchers led by Dr. Martin Ruwald of Copenhagen University Hospital Gentofte looked at more than 127,000 patients, median age 64, who were hospitalized for fainting between 1997 and 2009. Of those patients, more than one-fifth had experienced at least two fainting episodes. The researchers found that the risk of repeat fainting rose with the number of medications that patients were taking at the same time. For ... Read more

Related support groups: Lisinopril, Metoprolol, Atenolol, Amlodipine, Benicar, Losartan, Diovan, Hydrochlorothiazide, Bystolic, Lasix, Norvasc, Diltiazem, Spironolactone, Verapamil, Furosemide, Cozaar, Micardis, Ramipril, Nifedipine, Cardizem

Effects of High Blood Pressure Drug May Mimic Celiac Disease

Posted 22 Jun 2012 by Drugs.com

FRIDAY, June 22 – A new report suggests that the common blood pressure drug olmesartan (Benicar) can cause symptoms that mimic celiac disease, leading to misdiagnosis and unnecessary treatment. It's not clear how often people who take the blood pressure-lowering drug will develop the gastrointestinal problems that are similar to those caused by celiac disease. For the moment, though, the side effects appear to be unusual, said Dr. Peter Green, director of the Celiac Disease Center at Columbia University Medical School, who was not involved with the study. Still, Green noted, his center has seen patients who developed celiac disease-like symptoms while taking olmesartan and some have been quite ill. "One went into kidney failure and needed dialysis," he said. According to the new study from the Mayo Clinic in Rochester, Minn., 22 patients – aged 47 to 81, average age 70 – had symptoms ... Read more

Related support groups: Benicar, Azor, Benicar HCT, Olmesartan, Tribenzor, Amlodipine/hydrochlorothiazide/olmesartan, Amlodipine/Olmesartan, Hydrochlorothiazide/Olmesartan

U.S. Task Force Issues Blood Pressure Guidelines

Posted 15 May 2012 by Drugs.com

TUESDAY, May 15 – "Team-based care" should be used to improve patients' blood pressure control, the U.S. Task Force on Community Preventive Services recommended on Tuesday. The recommendation is based on a review of 77 studies that showed improvements in patients' control of blood pressure when they received care from a team of health professionals – a primary care doctor supported by a pharmacist, nurse, dietitian, social worker, or community health worker – rather than a primary care doctor alone. The task force found that team-based care increased the percentage of patients with controlled blood pressure, led to a decrease in both systolic (top number) and diastolic (bottom number) blood pressure, and improved results in patients with diabetes and elevated levels of blood fats. Team members assist primary care doctors by providing support and sharing responsibility for high blood ... Read more

Related support groups: High Blood Pressure, Lisinopril, Hypertension, Metoprolol, Atenolol, Amlodipine, Benicar, Losartan, Diovan, Propranolol, Bystolic, Norvasc, Diltiazem, Verapamil, Carvedilol, Cozaar, Micardis, Ramipril, Coreg, Nifedipine

Accidental Medication Poisonings in Kids on the Rise

Posted 16 Sep 2011 by Drugs.com

FRIDAY, Sept. 16 – Despite ongoing prevention efforts, a growing number of young children are being accidentally poisoned with medications, according to new research. The study, which was based on data reported to the American Association of Poison Control Centers between 2001 and 2008, found that medication poisoning among children aged 5 and under increased by 22 percent, although the number of children in the United States in this age group rose by only 8 percent during the study period. "The problem of pediatric poisoning in the U.S. is getting worse, not better," Dr. Randall Bond, of Cincinnati Children's Hospital Medical Center, said in a hospital news release. In conducting the study, which is scheduled for publication in the Journal of Pediatrics, the researchers reviewed information on over 544,000 children who landed in the emergency department due to medication poisoning ... Read more

Related support groups: Suboxone, Xanax, Oxycodone, Methadone, Percocet, Hydrocodone, OxyContin, Vicodin, Klonopin, Morphine, Lisinopril, Norco, Fentanyl, Lortab, Ambien, Clonazepam, Valium, Ativan, Codeine, Opana

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

Posted 4 Jun 2011 by Drugs.com

[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 fo ... Read more

Related support groups: Benicar, Losartan, Diovan, Cozaar, Micardis, Exforge, Azor, Benicar HCT, Avapro, Diovan HCT, Atacand, Hyzaar, Valsartan, Irbesartan, Avalide, Telmisartan, Olmesartan, Tribenzor, Candesartan, Micardis HCT

FDA Medwatch Alert: Benicar (olmesartan): Ongoing Safety Review

Posted 16 Apr 2011 by Drugs.com

[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 ... Read more

Related support groups: Benicar, Azor, Benicar HCT, Olmesartan, Tribenzor, Amlodipine/hydrochlorothiazide/olmesartan, Amlodipine/Olmesartan, Hydrochlorothiazide/Olmesartan

Blood Pressure Drug Delays Kidney Disease in Diabetics

Posted 10 Mar 2011 by Drugs.com

WEDNESDAY, March 9 – A drug normally used to lower blood pressure may also help protect the kidneys of people with type 2 diabetes, researchers are reporting with a caveat. In a new study, an international team of researchers found that the drug pressure-reducing medication olmesartan, brand name Benicar, could increase the time before any kidney problems were evident by 23 percent. The study measured the possibility of kidney function problems by measuring the amount of albumin secreted in the urine (microalbuminuria). "Olmesartan was associated with a delayed onset of microalbuminuria, even though blood-pressure control in both groups was excellent according to current standards," wrote the study's authors in a report published in the March 10 issue of the New England Journal of Medicine, "Microalbuminuria is a marker for renal disease, and preventing renal disease is important for ... Read more

Related support groups: Diabetes, Type 2, Benicar, Azor, Benicar HCT, Olmesartan, Tribenzor, Amlodipine/hydrochlorothiazide/olmesartan, Hydrochlorothiazide/Olmesartan, Amlodipine/Olmesartan

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