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Benicar® Labels to Include Risk of Adverse Cardiac Events, FDA Says

Posted on behalf of Stephens, Anderson & Cummings on Aug 01, 2014 in Dangerous Drugs

Benicar Labels to include risk of adverse Cardiac events FDA says

The hypertension medication Benicar has been linked to increased risk of heart attack and stroke in patients with type 2 diabetes, a clinical study suggests. Now, the U.S. Food and Drug Administration (FDA) has announced a mandatory change to the drugs label to include the newest findings.

In its Safety Announcement dated June 24, 2014, the FDA notes that it has not found a clear risk link between diabetic patients and Benicar, so its official usage recommendation will not be changed. In actuality, this statement means it will not be recalling Benicar, or other products using its active ingredient olmesartan, in light of the study's findings.

The trial itself, called ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention), was meant to examine Benicar's effectiveness at delaying kidney failure in this group; what it found instead was a link between olmesartan drugs, like Benicar, and an increased risk of cardiovascular death in the trial group of patients who had type 2 diabetes.

The FDA claims it reviewed additional findings to determine whether it deemed Benicar unsafe for consumers, including a study on Medicare patients. It believes the data is inconclusive, which means the labels will reflect findings of the ROADMAP study but no recommendations that diabetic patients or other groups are at any particular risk if they take Benicar.

Cardiac events are only the newest potential side effects of Benicar, which has been linked to sprue-like enteropathy, a gastrointestinal condition with symptoms that mimic celiac disease. Experts believe that patients taking Benicar and suffering from sprue-like enteropathy may not be aware the medication is causing their symptoms, which can include malnutrition, dehydration, severe diarrhea and drastic weight loss.

The effects of sprue-like enteropathy are not necessarily acute, meaning a Benicar patient could slowly develop these symptoms over time, thus adding to the confusion of their origins.

Any person who believes their gastrointestinal symptoms or cardiac event is related to their taking Benicar is encouraged to consult their doctor. Stephens, Anderson & Cummings also offers free case evaluations to anyone wishing to pursue compensation for the damages caused by this drug.

For a FREE review of your claim, fill out the online evaluation form here or call Stephens, Anderson & Cummings at 877.920.9009.