Sometimes, the medications we rely on to keep us healthy or comfortable end up doing more harm than good. If you or a loved one has suffered complications causing serious injury or death from a prescription drug, please call or contact us to discuss a possible claim against the company that makes this medication.
Benicar, Benicar HCT, Azor or Tribenzor FAQ
Gold, Khourey & Turak is investigating cases of digestive tract injury associated with a commonly prescribed blood pressure medication known as Benicar. Benicar has been prescribed to help lower high blood pressure in patients by helping the blood vessels in the body to widen and prevent constriction of the vessels. Benicar is an angiotensin II receptor blocker (ARB) that is sometimes prescribed in combination with other blood pressure medications. Benicar is one of eight marketed ARB drugs, but it’s the only one linked to serious and chronic gastrointestinal problems.
Benicar is currently available on the market in two tablet forms: Benicar (Olmesartan Medoxomil) and Benicar HCT (Olmesartan Medoxomil and Hydrochlorothiazide). Both Benicar and Benicar HCT have been widely prescribed by doctors since their approval by the FDA in 2002 and 2003, with 10.6 million prescriptions written for Benicar in the year 2012 alone. Daiichi Sankyo, the second largest pharmaceutical company in Japan, manufactures Benicar as well as two additional blood pressure medications, Azor and Tribenzor, both of which contain the active ingredient Olmesartan (found in Benicar).
Dangerous Side Effects
The specific injury that many users are experiencing while using these drugs is a gastrointestinal disease known as sprue-like enteropathy. In some cases, doctors are unaware of the serious intestinal health problems resulting from Benicar, often misdiagnosing patients as having Celiac disease, which is an autoimmune disorder that usually only occurs in people with a genetic predisposition. In many instances, patients were, in turn, prescribed the wrong treatment, like following a gluten-free diet or taking steroids.
Mayo Clinic Study
Dr. Joseph Murray, a gastroenterologist with the Mayo Clinic, was the first to publish on the link between Benicar use and the rare sprue-like enteropathy condition. Dr. Murray’s three-year study observed 22 patients that used Benicar who were experiencing gastrointestinal symptoms commonly associated with Celiac disease. Of the 22 patients, 14 had symptoms so severe that hospitalization was required.
Additionally, Dr. Murray’s patients did not respond to a gluten-free diet and they tested negative for Celiac disease. After discontinuing the use of Benicar, all 22 patients in Dr. Murray’s study felt the relief of the gastrointestinal symptoms they were previously experiencing, as well as recovery of the weight loss they suffered while on Benicar. Dr. Murray’s study is clear evidence that the only way to alleviate the symptoms of Benicar enteropathy is by discontinuing the medication. Based on the study’s observations, Dr. Murray concluded that there was a link between the use of Benicar and sprue-like enteropathy, and his report has since been published in the Mayo Clinic Proceedings.
A French nationwide cohort study released in June 2014 revealed an association between Benicar and severe intestinal malabsorption, which can lead to malnutrition, substantial weight loss, dehydration, and severe chronic diarrhea. The study found no link in patients taking other antihypertensive drugs, including ACE inhibitors or angiotensin receptor blockers (ARBs). The study also shows that patients who took Benicar for two or more years have 10 times the risk of suffering from these symptoms.
In July 2013, the U.S. Food and Drug Administration (FDA) approved a label change for Benicar to add a warning about the increased risks of sprue-like enteropathy to the drug’s label. They also issued a safety warning that Benicar, Azor, and Tribenzor can cause intestinal problems (sprue-like enteropathy). Symptoms of the disorder include severe, chronic diarrhea with substantial weight loss. In deciding to require new warnings, the FDA has evaluated numerous adverse event reports and found a direct link between Benicar, other olmesartan drugs like Azor and Tribenzor, and sprue-like enteropathy. Twenty-three serious cases were identified in these reports “as late-onset diarrhea with significant weight loss, and in some cases, with intestinal villous atrophy on biopsy.”
Xarelto (generic name Rivaroxaban) is a pill used to reduce the risk of stroke and blood clots in people with atrial fibrillation that is not caused by a heart valve problem. It is also prescribed to treat deep vein thrombosis (blood clots in the leg veins) and pulmonary embolism (blood clots in the lungs), and to help reduce the risk of clots coming back. Another use is to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
Xarelto is a fairly new blood thinner medication. Some people have experienced problems with excessive bleeding after taking it. If you or a family member has taken Xarelto and experienced internal bleeding that required hospitalization or a visit to the emergency room for blood or plasma transfusions, you may have a claim.