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  • Jefferson Adams
    Jefferson Adams

    See the Viral Video that Helped Spawn Benicar Lawsuit

      Curious about that video that sparked a lawsuit against the makers of Benicar? Watch it here.

    Caption: A viral video led to lawsuits against the makers of Benicar. Photo: CC--Michael Coghlan

    Celiac.com 11/15/2016 - The YouTube video that helped to spark litigation against blood pressure drug Olmesartan, also marketed as Benicar, was made by celiac disease expert Dr. Joseph Murray, a gastroenterologist and a professor of medicine at the Mayo Clinic in Rochester, New York, who is very familiar with the drug's side effects.

    In July 2013, the U.S. Food and Drug Administration (FDA) issued a warning to patients and doctors that the popular blood pressure medication Benicar had been linked to a severe side effect called sprue-like enteropathy. The side effect was easily confused with celiac disease or a gluten sensitivity, and caused serious problems in many patients, including cases of irreparable gut damage.

    A week after the FDA's warning, Dr. Joseph Murray took to YouTube to notify patients about the drug's risks. In the video, Dr. Murray advises anyone who is taking Benicar, and who has also been diagnosed with celiac disease, to consult a doctor about the FDA warning.

    Many Benicar patients learned the hard way the drug can cause debilitating side effects, but Dr. Murray's video no doubt helped spread awareness to patients who suffer from sprue-like enteropathy. Many patients feel Benicar's manufacturer, Daiichi Sankyo, failed to warn consumers of the risks associated with the drug and are now trying to hold the company responsible through legal action. There are more than 1,700 lawsuits currently pending against the company.

    Plaintiffs have called into question the validity of the clinical trial leading to Benicar's approval with the FDA. Managing high blood pressure is a long-term proposition, but the clinical trial testing Benicar's safety and efficacy only lasted three months.

    Plaintiffs believe the short clinical trial caused the makers to overlook the risk of sprue-like enteropathy, but plaintiffs are also pointing to the fact that drug maker Daiichi Sankyo spent $1 billion on Benicar advertising between 2002 and 2008. The plaintiffs say that company advertising focused more on the benefits of Benicar, while downplaying potential risks.

    The suit has been slate for court docket in 2017. Stay tuned for developments on this and related matters.

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  • About Me

    Jefferson Adams earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, science, and advanced research, and scientific methods. He previously served as Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

  • Related Articles

    Jefferson Adams
    Celiac.com 07/09/2014 - Does the blood pressure medication Benicar (Olmesartan medoxomil) trigger celiac-like gut symptoms?
    The law firm Levin, Papantonio has filed a lawsuit claiming just that, on behalf of a Texas man who allegedly developed a rare gastrointestinal condition known as sprue-like enteropathy while taking Benicar.
    According to the complaint, Benicar caused the plaintiff to suffer severe gastrointestinal symptoms, including chronic diarrhea, weight loss, malnutrition, and dehydration. These symptoms are commonly associated with a rare sprue-like enteropathy.
    The lawsuit comes as Benicar faces scrutiny following a Mayo Clinic study linking the popular drug to rare sprue-like enteropathy in users.
    The connection between Benicar and the sprue-like enteropathy symptoms was first noted by Mayo Clinic gastroenterologist, Dr. Joseph Murray, after he observed two patients taking Benicar experience relief from symptoms thought to be associated with Celiac disease. Upon discontinuing the use of Benicar, the gastrointestinal symptoms vanished.
    Dr. Murray then conducted a three-year study of 22 people who experienced celiac-like symptoms while taking Benicar. He found that 14 of those patients had symptoms so severe that hospitalization was required.
    Moreover, none of the 22 original patients responded to a gluten-free diet, and none showed any detectable levels of tissue transglutaminase in the blood, which would point to celiac disease.
    After discontinuing the Benicar treatments, the intestinal symptoms disappeared in each of the 22 patients, and they all regained lost weight.
    In 2013, in keeping with Dr. Murray’s findings, the U.S. Food and Drug Administration changed Benicar’s label to include a warning that the drug may trigger sprue-like enteropathy and symptoms similar to celiac disease.
    If you think you may have suffered adverse effects from Benicar, check with your doctor, and possibly with a lawyer.
    Sources:
    Mayo Clinic: Study on Benicar and sprue-like enteropathy FDA Safety Communication Concerning Label Change on Benicar, 2013. digitaljournal.com.

    Jefferson Adams
    Celiac.com 01/19/2016 - Cases of autoimmune diseases are on the rise, and mirror the expansion of industrial food processing and increased use of food additives. The intestinal epithelial barrier, with its intercellular tight junction, controls the balance between tolerance and immunity to non-self-antigens.
    Recently, a team of researchers set out to assess the role of tight junction dysfunction in the pathogenesis of autoimmune disease.
    Researchers Aaron Lerner and Torsten Matthias are associated with the Pediatric Gastroenterology and Nutrition Unit, Carmel Medical Center, B, Rappaport School of Medicine, Technion-Israel Institute of Technology, Michal in Haifa, Israel, and the Aesku Kipp Institute in Wendelsheim, Germany.
    Numerous common industrial food additives increase tight junction leakage. These include glucose, salt, emulsifiers, organic solvents, gluten, microbial transglutaminase, and nanoparticles, widely and increasingly used in industrial food production.
    According to manufacturers, these additives improve food quality. However, all of the aforementioned additives increase intestinal permeability by breaching the integrity of tight junction paracellular transfer.
    So why is this a problem?
    Well, it turns out that tight junction dysfunction is common in multiple autoimmune diseases, and the central part played by the tight junction in autoimmune diseases development is widely described.
    The researchers hypothesize that commonly used industrial food additives undermine human epithelial barrier function, which increases intestinal permeability through the opened tight junction, resulting in entry of foreign immunogenic antigens and activation of the autoimmune cascade, and the development of autoimmune conditions, such as celiac disease.
    The team is calling for additional research on the connections between food additives exposure, intestinal permeability, and autoimmunity interplay to expand our knowledge of the common mechanisms associated with autoimmune progression.
    Source:
    tx.technion.ac.il

    Jefferson Adams
    Celiac.com 09/15/2016 - Some doctors and clinicians have reported cases of severe sprue-like enteropathy associated with olmesartan, but, until now, no clear demonstration of an increased risk has been documented by epidemiological studies.
    Now, a French nationwide observational cohort study has shown a connection between severe intestinal malabsorption and the drug olmesartan, according to results presented by a team of researchers. Olmesartan is an angiotensin II receptor antagonist which has been used for the treatment of high blood pressure. Olmesartan is also sold commercially under the name Benicar.
    The research team included Mickael Basson, Myriam Mezzarobba, Alain Weill, Philippe Ricordeau, Hubert Allemand, Francois Alla, and Franck Carbonnel. They are variously affiliated with the French National Health Insurance Fund, Paris, France, and the Université Paris-Sud, Assistance Publique-Hôpitaux de Paris and Gastroenterology unit, Hôpitaux Universitaires Paris Sud, Le Kremlin Bicêtre, France.
    The team set out to assess, in a nationwide patient cohort, the risk of hospitalization for intestinal malabsorption associated with olmesartan compared with other angiotensin receptor blockers (ARB) and ACE inhibitors (ACEIs). From the French National Health Insurance claim database, they included all adult patients initiating ARB or ACEI between 1 January 2007 and 31 December 2012, with no prior hospitalization for intestinal malabsorption, no serology testing for celiac disease, and no prescription for a gluten-free diet product. Their main endpoint was incidence of hospitalization with a discharge diagnosis of intestinal malabsorption.
    The team included 4,546,680 patients, for a total of 9,010,303 person-years, and observed 218 events. Compared with ACEI, the adjusted rate ratio of hospitalization with a discharge diagnosis of intestinal malabsorption was 2.49 (95% CI 1.73 to 3.57, p
    Average length of hospital stay for intestinal malabsorption was longer in the olmesartan group than in the other groups (p=0.02).
    Compared with ACEI, the adjusted rate ratio of hospitalization for celiac disease was 4.39 (95% CI 2.77 to 6.96, p<0.0001).
    These results show that olmesartan is assoc qiated with higher rates of hospitalization for intestinal malabsorption and celiac disease.
    Source:
    Gut. doi:10.1136/gutjnl-2015-309690

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