Affiliations: [a] Eritrean Pharmacovigilance Centre, National Medicines and Food Administration, Asmara, Eritrea | [b] Orotta College of Medicine and Health Sciences, Asmara, Eritrea | [c] Biet-Mekae Community Hospital, Asmara, Eritrea | [d] Department of Public Health, Ministry of Health, Asmara, Eritrea | [e] National Medicines and Food Administration, Asmara, Eritrea
Correspondence:
[*]
Address for correspondence: Mulugeta Russom, Eritrean Pharmacovigilance Centre, National Medicines and Food Administration, Asmara, Eritrea. Tel.: 00291 7197450; E-mail: [email protected]
Abstract: BACKGROUND:Ranitidine injection is not well-known to cause cardiac arrest except in few published case reports. The Eritrean Pharmacovigilance Centre received four cases of cardiac arrest associated with ranitidine injection. OBJECTIVE:To assess the causal relationship between cardiac arrest and ranitidine, and to identify possible risk factors. METHODS:This is a descriptive case series assessment of cardiac arrest associated with ranitidine and data was mined to supplement the cases from the WHO global database of individual case safety reports. RESULTS:In all cases, ranitidine injection was administered fast IV bolus without proper dilution and the outcome was fatal in three. All patients encountered cardiac arrest within 20 minutes of intravenous use. Causality was found to be probable in two cases and possible in the other two. Cardiac arrest could have been prevented in all cases. On top of this, from the WHO global database, 185 cases of cardiac arrest and cardio-pulmonary arrest associated with ranitidine were retrieved and 49.7% were fatal. In 40% of the cases, ranitidine was reported as a single suspect. In 36 cases, cardiac arrest resolved following withdrawal of ranitidine and reaction recurred in one case after re-introduction of the product. CONCLUSION:There appears a causal link between ranitidine and cardiac arrest, possibly related to medication errors that warrants immediate attention from healthcare professionals.
Keywords: Intravenous ranitidine, administration error, cardiac arrest, WHO global database, healthcare, risk factors
