The blood-pressure drug Benicar has been linked to sprue-like enteropathy, an intestinal disease that causes chronic diarrhea, severe weight-loss, and intestinal damage. Symptoms may not appear for years and it is easily mistaken for Celiac disease (gluten allergy).
Need a Texas Benicar Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by Benicar, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: Benicar Lawyers Ask Judge to Rule on General Causation
September 2, 2016 — Lawyers have asked judges to agree that Benicar causes enteropathy so they can pursue claims that drug-makers failed to warn about the risk. Click here to read more.
July 13, 2016 — A federal judge overseeing 1,350 Benicar lawsuits has pushed back the first trial dates until 2017. Click here to read more.
October 6, 2015 — With at least 1,046 federal Benicar lawsuits pending against Daiichi Sankyo, the federal judge overseeing the litigation wants the first trials in late 2016. Click here to read more.
August 17, 2015 — The number of Benicar lawsuits has skyrocketed from 70 in June to at least 990 today, according to statistics released today by federal judges overseeing the litigation. Click here to read more.
May 26, 2015 — At least 45 lawsuits involving people who took Benicar and developed sprue-like enteropathy have been filed in a federal Multi-District Litigation (MDL No. 2606) since it was created last month. Click here to read more.
April 6, 2015 — A panel of federal judges has centralized 35 lawsuits involving intestinal side effects of Benicar into one Multi-District Litigation (MDL No. 2606) in New Jersey, under Judge Robert B. Kugler. Click here to read more.
January 19, 2015 — Two men from California who developed sprue-like enteropathy after taking Benicar have filed a lawsuit against Daiichi Sankyo and Forest Laboratories. Click here to read more.
January 12, 2015 — Daiichi Sankyo has agreed to pay a $39 million settlement to the federal government to resolve allegations of illegally marketing drugs like Benicar, Azor, and Tribenzor by paying kickbacks to prescribing physicians. Click here to read more.
December 23, 2014 — Attorneys for a woman who was diagnosed with sprue-like enteropathy after taking Benicar have asked a panel of federal judges to centralize dozens of lawsuits in one federal Multi-District Litigation (MDL) in Ohio. Click here to read more.
November 20, 2014 — A study suggests that abdominal pain and enteropathy may be side effects of Benicar (olmesartan), but not other blood-pressure drugs in the same class.
September 24, 2014 — French researchers have reported 36 cases of sprue-like enteropathy in patients on Benicar, confirming other studies suggesting a causal connection to this serious side effect. Click here to read more.
August 6, 2014 — A lawsuit has been filed by a woman who took Benicar and endured more than three years of intestinal side effects (sprue-like enteropathy) because she was misdiagnosed. Click here to read more.
August 1, 2014 — According to Forbes, some experts are questioning recent conclusions from the FDA that Benicar (olmesartan) does not increase the risk of cardiovascular events for people with type-2 diabetes on high doses. Click here to read more.
July 24, 2014 — Benicar has been linked to a severe case of sprue-like enteropathy that caused a colon perforation, according to a report in Case Reports in Gastrointestinal Medicine. Researchers in France have also linked Benicar to a 10-fold increased risk of hospitalization for gastrointestinal problems. Click here to read more.
July 3, 2014 — A woman from San Diego, California has filed a lawsuit (PDF) against Daiichi Sankyo, alleging that the blood-pressure drug Benicar caused her to suffer sprue-like enteropathy. The case was transferred to the U.S. District Court for the Southern District of California on June 17. Click here to read more.
June 25, 2014 — Despite several clinical trials linking high-dose Benicar with higher rates of deadly heart attacks and cardiac arrest, the U.S. Food and Drug Administration (FDA) has concluded that Benicar does not raise cardiovascular risks. Click here to read more.
Benicar Enteropathy “May Not Be Rare”
The journal Digestive and Liver Disease has published a study in March 2014 linking Benicar and five cases of sprue-like enteropathy (chronic diarrhea and weight-loss), bringing the total number of known cases to 27. According to researchers: “All cases were observed in a small gastroenterology unit, which suggests that this adverse effect may not be rare.” Click here to read more.
Texas Man Files Benicar Lawsuit for Chronic Diarrhea
February 2014 — The first Benicar lawsuit has been filed by a man from Texas who developed chronic diarrhea. Doctors repeatedly mis-diagnosed his disease, resulting in 10 hospitalizations for over 100 days in the last four years. The plaintiff, George Edward Williams, suffered permanent intestinal damage, diarrhea, nausea, vomiting, dehydration, malnutrition, and weight-loss. He also had a feeding peg inserted directly into his stomach, which he still uses to eat. Click here to read more.
What is Benicar?
Benicar (olmesartan modoxomil) is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure (hypertension). In 2012, approximately 1.9 million patients used Benicar. It was approved on April 25, 2002. Other drugs that contain olmesartan include Azor and Tribenzor.
What is the problem?
Benicar was known to cause diarrhea when it was approved, but after evaluating adverse events, experts discovered a link between Benicar and sprue-like enteropathy. Another problem is that sprue-like enteropathy is easily mis-diagnosed as Celiac disease. This can delay the correct diagnosis and treatment until the patient has suffered significant health problems.
Benicar and Sprue-Like Enteropathy
The link between Benicar and sprue-like enteropathy was discovered by Dr. Joseph Murray, a gastroenterologist with the Mayo Clinic, and published in Mayo Clinic Proceedings in August 2012.
Between August 2008 and August 2011, Dr. Murray observed 22 patients on Benicar who developed gastrointestinal inflammation, including 14 who were hospitalized. The symptoms were similar to Celiac disease, but patients tested negative for Celiac disease and did not improve on a gluten-free diet. After discontinuing Benicar, all 22 patients improved and gained weight. Based on this study, Dr. Murray concluded that Benicar could cause sprue-like enteropathy.
FDA Warning for Benicar and Intestinal Problems
July 3, 2013 — The U.S. Food and Drug Administration (FDA) has published a Drug Safety Communication to warn that Benicar can cause intestinal problems known as sprue-like enteropathy. The FDA has received 23 reports of the disease; all patients improved after discontinuing Benicar.
According to the FDA, the long delay before onset of symptoms and other factors suggest that the link between Benicar and diarrhea is due to a localized hypersensitivity or cell-mediated immune response. Other experts suggest that Benicar inhibits TGF-β, an important mediator of gut homeostasis, but this does not explain why other ARBs do not cause sprue-like enteropathy.
- Patients who develop severe, chronic diarrhea with substantial weight-loss should contact a healthcare professional.
- Symptoms of sprue-like enteropathy can develop months or years after starting Benicar.
FDA Calls Benicar Ads “False or Misleading”
In 2006, the FDA sent Daiichi Sankyo a Warning Letter after finding that ads for Benicar were in violation of federal law because they suggested — without providing evidence — that Benicar was superior and more effective to other blood-pressure drugs. According to the FDA:
“The sales ad is false or misleading because it contains unsubstantiated effectiveness and superiority claims, and omits and minimizes information on the risks … These claims and omissions raise significant public health and safety concerns.”
Benicar Celiac Disease
Symptoms of Celiac disease (gluten intolerance) are nearly identical to symptoms of enteropathy from Benicar. Internal biopsies may also be very similar. Misdiagnosis is very common. However, unlike Celiac disease, enteropathy from Benicar does not get better on a gluten-free diet or with inflammation-suppressing corticosteroid treatments. The only cure is stopping Benicar.
What is Sprue-Like Enteropathy?
Sprue-like enteropathy is a gastrointestinal disease characterized by chronic diarrhea and severe weight-loss. The symptoms are nearly identical to Celiac disease (also known as celiac sprue), which is caused by gluten sensitivity.
Over time, enteropathy damages the mucous lining of the intestines, destroys intestinal villi, and flattens the lining the of the intestine (a process called intestinal villous atrophy). This causes poor digestion and absorption of food nutrients.
Benicar and Kidney Failure
Benicar has been associated with post-marketing reports of acute kidney failure and other kidney problems. Before starting Benicar, you may need to have a blood test to check baseline kidney function. The risk of kidney problems increases for high-risk patients, such as elderly patients on NSAIDs (aspirin, ibuprofen, etc.), diabetic patients on Tekturna (aliskiren), patients with heart failure, and more.
Benicar Side Effects
- Sprue-like enteropathy
- Chronic diarrhea
- Severe weight loss
- Nausea and vomiting
- Intestinal damage
- High or low blood pressure (hypertension of hypotension)
- Kidney failure
- Click here for a list of Benicar side effects
Need a Benicar Lawyer in Texas?
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