Safety assessment of omeprazole use: a review

Author(s)

Forgerini, Marcela ^[1] ; Mieli, Stephania ^[2] ; Mastroianni, Patricia de Carvalho ^[3]

Affiliation

^[1] Univ Estadual Paulista UNESP, Postgrad Program Pharmaceut Sci, Araraquara, SP - Brazil

^[2] Univ Estadual Paulista UNESP, Araraquara, SP - Brazil

^[3] Univ Estadual Paulista UNESP, Dept Drugs & Med, Araraquara, SP - Brazil

• Document type: Journal article
• Source: São Paulo Medical Journal; v. 136, n. 6, p. 557-570, NOV-DEC 2018.
• Web of Science Citations: 1

Abstract

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. (AU)

• FAPESP's process: 14/03468-6 - Evaluation of the risk benefit of the use of Omeprazole: a systematic review
• Grantee: Stephania Furlanetto Mieli
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• FAPESP's process: 13/12681-2 - Evaluation of the prophylactic use of omeprazole in patients admitted to the State Hospital of Américo Brasiliense
• Grantee: Patricia de Carvalho Mastroianni
• Support Opportunities: Regular Research Grants