Olmetec Blood Pressure Drug Side Effects Class Action Lawsuit

+ - Documents (4)

CONSUMER LAW GROUP has launched a Canadian-wide class action against Merck Canada Inc., Schering-Plough Canada Inc. and Daiichi Sankyo Company, Ltd., the manufacturers of OLMETEC and OLMETEC PLUS, on behalf of individuals who have suffered serious gastrointestinal side effects such as chronic diarrhea, Olmesartan-induced enteropathy (OAE), villous atrophy/blunting/damage, nausea, malnutrition, and dehydration after taking the blood pressure medication.

OLMETEC’s active ingredient is Olmesartan Medoxomil. OLMETEC PLUS’s active ingredients are Olmesartan Medoxomil and Hydrochlorothiazide. They are considered angiotensin II receptor blockers (ARB) and are sold as a treatment for hypertension (high blood pressure) and other medical conditions, including renal disease.

The U.S. equivalent, known as Benicar and Benicar HCT, are manufactured by Daiichi Sankyo. The makers of Benicar, Benicar HCT, Azor and Tribenzor are currently involved in ongoing litigation by multiple consumers across the U.S. for allegedly causing intestinal and/or colonic disease manifestations known as sprue-like enteropathy (or celiac-like symptoms) and/or lymphocytic colitis, microscopic colitis, or collagenous colitis.

The makers of Olmesartan Medoxomil drug products are alleged to not have adequately warned consumers of the gastrointestinal and related side effects and sequelae beginning with the first marketing of the Olmesartan products, and to have failed to affirmatively notify the medical and patient communities of the full scope of risks known to be associated with and caused by these products.

The alleged side effects of OLMETEC AND OLMETEC PLUS plus include, but are not limited to:

• Diarrhea (severe or chronic);
• Vomiting and nausea;
• weight loss;
• Dehydration and malnutrition (malabsorption of nutrients)
• Intestinal damage;
• Sprue-like enteropathy;
• Villous atrophy/blunting/damage;
• Inflammation;
• Atrophy;
• Kidney failure;
• Abdominal and gastrointestinal pain;
• Colitis;
• Gastritis; and/or
• Immune system problems.

These side effects may develop months or years after starting the drug and sometimes require hospitalization. Due to the celiac-like symptoms, physicians usually believe that patients who present such symptoms have Celiac disease, however they are often diagnosed with sprue-like enteropathy or villous atrophy.

Since 2014, warnings have been included on the U.S. labels after the U.S. FDA cited numerous studies that demonstrated no other drug in the ARB class causes such side effects. The makers are alleged to not have conducted proper research and testing before launching their product into the marketplace. It is alleged that consumers were put at risk by a product that is both dangerous and defective, without adequate warning and labelling.

The following are some case reports, studies, and data that further support the causal association:

• In July 2013, the FDA identified 23 serious cases in the FAERS presenting onset diarrhea with significant weight loss and, in some cases, with intestinal villous atrophy on biopsy. All patients improved clinically after discontinuance of Olmesartan Medoxomil;

• In early 2014, a group of physicians out of France published a case series which reported five cases of Olmesartan induced injury. All five had positive dechallenge results. The patients’ symptoms returned with each reintroduction of the Olmesartan product. The authors concluded that the rechallenge data argued strongly in favour of Olmesartan being responsible, and also that “this ADR may not be as rare as it may first appear.”;

• In 2014, a literature review published in Alimentary Pharmacology and Therapeutics reviewed 11 publications and 54 patients, including three additional patients diagnosed by the authors. The literature review revealed that the mean duration of Olmesartan use was 3.3 years, duodenal villous atrophy was present in nearly all of the reported cases, and increased intra-epithelial lymphocytes were in nearly two-thirds of the cases. All of the cases showed improvement upon discontinuation of the Olmesartan product. The authors concluded that “Olmesartan-associated sprue-like enteropathy may be considered as a distinct clinical entity, and should be included in the differential diagnosis of seronegative villous atrophy.”;

• An epidemiological study from France provided the strongest causation evidence in the published literature to date. The study examined the risk of severe intestinal malabsorption associated with Olmesartan, compared to other ARBs and ACE inhibitors. The authors found that “Olmesartan was associated with an increased risk of severe intestinal malabsorption."

If you or a member of your family have used the blood pressure drug OLMETEC or OLMETEC PLUS and suffered any of the above-mentioned side effects and you wish more information on potential compensation or to be kept advised of the status of the OLMETEC BLOOD PRESSURE DRUG SIDE EFFECTS CLASS ACTION litigation or any resulting compensation from the OLMETEC BLOOD PRESSURE DRUG SIDE EFFECTS lawsuit in Canada, Quebec or Ontario, please provide your contact information to our law firm using the below form.

IF YOU WISH TO JOIN THE CLASS ACTION OR TO SIMPLY GET MORE INFORMATION, PLEASE COMPLETE THE FORM BELOW. Please note that providing your information creates no financial obligation for you. You are not charged any fee or cost for joining this class action. Our law firm is paid a contingency fee from the compensation recovered, only if the class action is successful. All information contained in this transmission is confidential and Consumer Law Group agrees to protect this information against unauthorized use, publication or disclosure.