Lawyers for Benicar Sprue-Like Enteropathy Allegations: Resource4thePeople Now Offering No-Cost Consultations

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National network of attorneys is providing these consultations to consumers seeking information about their legal rights to seek compensation over allegations of serious gastrointestinal disorder

Resource4thePeople announced today that its national network of lawyers is now offering free consultations to consumers who allegedly suffered sprue-like enteropathy from the use of the blood-thinner Benicar.

The U.S. Food and Drug Administration has issued a National Drug Safety Communication* warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause these severe intestinal problems.

"Our experienced team of lawyers is now being made available to inform consumers of the legal options that they may have in regards to seeking compensation over the warning issued by the FDA," said Resouce4thePeople.

"As outlined by the FDA in its national drug safety communication, this condition known as sprue-like enteropathy can cause serious life-changing side effects that can have devastating health consequences."

In its July 3, 2013 announcement, the FDA said that it "is warning that the blood pressure drug Olmesartan Medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.

"Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. FDA has approved changes to the labels of these drugs to include this concern. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan."

FDA officials also said that they will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available.

"This is a serious gastrointestinal disease and, as outlined by the FDA, the crippling consequences of this horrible side effect are severe or continual diarrhea, significant weight loss and devastating physical and mental harm," said Resource4thePeople.

Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs.

In its announcement, the FDA also said:

  •     Health care professionals should tell patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if it takes months to years for symptoms to develop.
  •      Patients should contact their health care professional right away if they take an olmesartan-containing product and experience severe diarrhea, diarrhea that does not go away, or significant weight loss.
  •     Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

The link between Benicar and similar blood-thinners and this condition was first uncovered by medical experts at the Mayo Clinic, who were researching Benicar in connection with celiac disease but found that gastrointestinal symptoms significantly decreased after the discontinuation of their treatment with Benicar.

The Mayo Clinic researcher's findings were published on the U.S. National Library of Medicine's National Center for Biotechnology page in August of 2012.**

The study said that 22 patients included in this report were seen at Mayo Clinic in Rochester, Minnesota, between August 1, 2008, and August 1, 2011, for evaluation of unexplained chronic diarrhea and enteropathy while taking olmesartan.

Celiac disease was ruled out in all cases. To be included in the study, the patients also had to have clinical improvement after suspension of olmesartan, the researchers said.

The scientists concluded that olmesartan may be associated with a severe form of sprue-like enteropathy and that clinical response and histologic recovery are expected after suspension of the drug.

"The clinical observation of improvement of gastrointestinal symptoms and subsequent demonstration of histologic recovery after olmesartan withdrawal prompted us to advise our patients with unexplained sprue-like enteropathy to discontinue olmesartan," said the researchers. "We reported our observation to US Food and Drug Administration officials and submitted reports using the MedWatch system."

The FDA approved Benicar in 2002 for the treatment of high blood pressure in adults. The FDA says Benicar (also known as olmesartan) is in the class of drugs called angiotensin II receptor blockers (ARBs).

These drugs and a closely related group of drugs called angiotensin-converting enzyme inhibitors (ACEIs) have been evaluated in many studies involving thousands of patients at high-risk for cardiovascular events, such as patients who had a previous heart attack or had heart failure, said the FDA. Benicar is also sold in combination with hydrocholorothiazide as Benicar HCT for the treatment of high blood pressure.

The FDA said lowering blood pressure is a vital function of some medications to lower the risk of patients suffering fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

"If you or a loved one has suffered sprue-like enteropathy as a result of the use of Benicar or any other similar blood thinner we encourage you to take advantage of these complimentary consultations in order to preserve whatever legal rights you may have to seek compensation for your condition," said Resource4thePeople.


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