Olmetec

Scientific studies have linked Olmetec and Olmetec Plus to gastrointestinal and related side effects. These side effects 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;
• Immune system problems.

Scientific studies and case reports include:

• 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 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 the reported cases, and increased intra-epithelial lymphocytes were in nearly two-thirds of the cases. All 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."