How Benicar Works. Benicar is a commonly prescribed drug for individuals suffering from hypertension (high blood pressure), a condition impacting an estimated 67 million Americans. Benicar (olmesartan medoxomil) was approved by the U.S. Food and Drug Administration (FDA) in 2002 and belongs to the ARB (angiotensin receptor blocker) class of blood pressure medications.
Benicar works by blocking the activity of angiotensin-ll in the cardiovascular system. The liver generates angiotensin-ll, a protein that causes blood vessels to constrict, which then raises blood pressure. When blood pressure is too high, the heart must work harder to pump blood and oxygen throughout the body. High blood pressure may damage other organs, for example, the kidneys. Lower blood pressure results when Benicar blocks the production of angiotensin-ll, because the blood vessels do not constrict blood flow. Olmesartan, the active ingredient in Benicar, lowers blood pressure, but causes symptoms similar to colitis and other gastrointestinal complaints.
One of the most serious side effects of Daiichi Sankyo’s Benicar, is sprue-like enteropathy, a condition that duplicates the symptoms of celiac disease. Sprue-like enteropathy symptoms are severe, chronic diarrhea, and significant weight loss. A blood test can rule out celiac disease as a cause.
Personal injury attorneys at Parker Waichman LLP are actively investigating potential lawsuits on behalf of individuals who have been affected by adverse side effects of alleged defective medications.
The FDA insisted in July 2013, that Benicar add a warning that side effects may include sprue-like enteropathy. This decision by the FDA was largely due to a study done by the Mayo Clinic. The FDA said in no uncertain terms that the regulators found “clear evidence of an association between olmesartan and sprue-like enteropathy.” Patients who originally were thought to have celiac disease all tested negative. Researchers then discovered that patients had been taking Benicar or other olmesartan-based medicines. Of the 22 patients examined, 14 landed in the hospital with gastrointestinal complications.
The American Journal of Gastroenterology published a report in May 2013 that said patients who tested negative for celiac disease were shown to have villous atrophy. As soon as patients stopped using Benicar, the colitis symptoms subsided and they were able to gain weight.
The villi are tiny, tentacle-like growths that cover the walls of the intestines and absorb nutrients from foods people eat. Villous atrophy is when the villi have eroded away the insides of the intestines making them too smooth to absorb nutrients, resulting in people becoming malnourished.
In some cases, it takes years for patients to recognize the association of gastrointestinal complications and their blood pressure drug.
Additional side effects reported in clinical trials include: rash, irregular heartbeat, chest pain, arthritis, hair loss, nausea, vomiting, liver and kidney problems, and angioedema (skin swelling).
Currently at least two sets of generics from competing manufacturers have arrived on the market making olmesartan available to more Americans. Although causes of high blood pressure may include poor diet and lack of exercise, aging and genetic predisposition may also be a contributor. With the side effect of sprue-like enteropathy, with many patients requiring hospitalization, Benicar lawsuits allege the high blood pressure medication is a defective product.
Thanks to the expiration of the olmesartan patent that had given Daiichi Sankyo exclusive manufacturing and distribution rights, olmesartan is now available to even more individuals, with the appearance of the recently marketed generic versions of Benicar and Benicar HCT (olmesartan medoxomil and hydrochlorothiazide) earlier this year. Lupin Limited (lupin), is a more recent addition to the U.S. pharmaceutical market.
Lupin Limited is based in Mumbai, India and has entered the American market in Baltimore, Maryland as Lupin Pharmaceuticals, Inc. Lupin Limited announced in December 2016 that it has secured tentative FDA approval for their generic version of Benicar.
Generics are typically less expensive than brand names with the assumption that olmesartan will now be available to a greater number of people. With the increase in use, it is presumed there will be additional complaints of Benicar side effects, such as sprue-like enteropathy.
The warning labels insisted on by the FDA was based on 23 serious cases of Benicar illness and weight loss that has allegedly resulted in death. In the U.S. District Court of New Jersey with the presiding Judge Robert B. Kugler, on November 8, 2016, the death of a 70-year old Benicar patient in France was related to use of olmesartan. This underlined the alleged serious, negative health impacts of olmesartan on the elderly.
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