FDA Calls for Label Changes on Benicar
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- FDA Calls for Label Changes on Benicar
The U.S. Food and Drug Administration (FDA) has completed a safety review of Benicar and other olmesartan drugs and has requested that drug manufacturers update the labels on these drugs.
According to the FDA, the labels should include information about some of these studies and reviews. The safety review by the FDA was prompted by results of a ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) trial that examined the effects or using olmesartan in patients with type 2 diabetes.
Although the FDA believes there was no clear evidence of medical complications, the ROADMAP trial has found that there was an increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo. The FDA believes that the benefits of olmesartan drugs outweigh the potential risks, however, patients are advised to speak with their healthcare professionals about any concerns they have taking the drug.
A different study, the Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial, also suggested that a high-dose of olmesartan could result in cardiovascular risks among diabetic patients.
This data raises concerns about possible cardiovascular disease risks among diabetic patients who use Benicar, Benicar HCT, and other olmesartans. If you begin to experience cardiovascular disease symptoms such as chest pain, shortness of breath or heart arrhythmias, speak to your doctor right away.
This is the second time the FDA has approved labels for Benicar in less than two years. In 2013, the FDA called on drug manufacturers to include information on the link between Benicar and gastrointestinal problems. Many consumers who have taken Benicar and Benicar HTC have suffered sprue-like enteropathy symptoms, which can be similar to symptoms of Celiac disease.
If you or someone you know has suffered serious side effects prior to these label changes, the victim may be entitled to file a Benicar lawsuit. The Mesa personal injury attorneys at Phillips Law Group can help you determine what your legal rights are.
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