Safety assessment of omeprazole use: a review

Abstract

BACKGROUND: Risks regarding hospital admission due to adverse drug reactions and drug interactions from use of omeprazole have been reported. The question guiding the present review was "Which adverse events occur in patients using omeprazole in a Food and Drug Administration-approved and/or off-label manner?" It was also proposed to evaluate the safety of use of omeprazole. DESIGN AND SETTING: Qualitative narrative review with critical evaluation, in a public university. METHODS: The PubMed, SCOPUS, LILACS, SciELO, EMBASE and EBSCO databases were searched on July 31, 2018. Studies evaluating adverse events were screened. RESULTS: 72 articles were included, among which 58 reported on adverse drug events (47, adverse drug reactions; 5, drug interactions; and 6, situations of ineffectiveness). 28 adverse drug reactions not described in compendia and drug leaflets were described in these studies: myocardial infarction (6); stroke (2); spontaneous abortion (1); proliferative changes (1); chills (1); heart failure (1); thrombosis (2); and dementia (1), among others. Severe adverse reactions, for instance cardiac problems, Steven-Johnson syndrome and proliferative changes, were identified. The antiplatelet effects of drugs such as clopidogrel, in patients who underwent heart-related surgery, increased the risk of developing cardiac problems, such as cardiovascular death, myocardial infarction and stroke. In newly transplanted patients, decreased absorption of mycophenolate mofetil occurred, thus leading to rejection of transplanted organs. CONCLUSION: Use of omeprazole should be monitored primarily in patients with heart disorders using antiplatelet agents concomitantly, and in newly transplanted patients using mycophenolic acid, in order to avoid serious adverse reactions.

Electrophilic Chlorine from Chlorosulfonium Salts: A Highly Chemoselective Reduction of Sulfoxides

“…Proton pump inhibitors used for the treatment of gastroesophageal reflux, peptic ulcers and Zollenger–Ellison syndrome, such as a36 and a37 (omeprazole and lansoprazole, respectively), were reduced in very good yields, obtaining the corresponding sulfides b36 and b37 . These molecules, along with albendazole, b38 , a medicine used to treat parasitic infections, showed the compatibility of our method with nitrogen heterocycles, small carbamates and basic functional groups.…”

Who gets prescriptions for proton pump inhibitors and why? A drug-utilization study with claims data in Bavaria, Germany, 2010–2018

“…The additional relative reduction in the dispensing of omeprazole in Bavaria was probably due to the growing awareness of the suspected decrease in efficacy of the antiplatelet agent clopidogrel induced by omeprazole/esomeprazole [ 28 ] and the EMA safety communication. Conjoint use of clopidogrel and esomeprazole increased during this time, but the absolute proportions were very small.…”

Safety of the Geneva Cocktail, a Cytochrome P450 and P-Glycoprotein Phenotyping Cocktail, in Healthy Volunteers from Three Different Geographic Origins

“…Omeprazole is not known for SAEs at therapeutic doses during short-term treatments even though a recent review assessed the AEs reported in studies of different designs (e.g., clinical trials, cohort studies) and occurring at normal doses [22]. The usual maximum concentration observed after a single dose of omeprazole shows a large inter-individual variability range, for example, from 300 to 640 ng/mL after a single 40-mg dose of encapsulated enteric-coated granules [23].…”