Intravenous ranitidine injection and risk of cardiac arrest: Medication errors.

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.

Risk Factors of Gout in MDR-TB Patients in Eritrea: A Case-Control Study.

Though the incidence of gout in general population is less than 5% (globally), a study conducted in Eritrea among patients with multidrug resistant tuberculosis (MDR-TB) revealed a higher incidence (25%). Other similar studies conducted elsewhere, however, did not report gout as an adverse effect. It is unknown why a higher incidence of gout is being reported in Eritrea compared to similar studies from other countries. The objective of this study is therefore to explore risk factors for the increased risk of incident gout among MDR-TB patients in Eritrea. A case-control study was conducted in Merhano MDR-TB National Referral Hospital in Eritrea. All MDR-TB patients diagnosed with gout between June 2011 and June 2018 were considered as cases. Controls matched by age, sex, and cumulative drug exposure time were selected from the same study population (1:1 ratio). A total of 84 MDR-TB patients, 42 cases and 42 controls, were included in this study. No patient from the control group has comorbidities, while six patients from the case group have diabetes (χ2 = 6.46, df=1, p=0.026). Patients having tachycardia (OR=3.26, 95% CI=1.28, 8.27), alopecia (OR=3.11, 95% CI=1.00, 9.67), and gastrointestinal upset (OR=3.17, 95% CI=1.26, 7.96) as adverse effects and being on prolonged use of propranolol (OR=3.26, 95% CI=1.28, 8.27) were found to be more likely to develop incident gout compared to their controls. In conclusion, MDR-TB patients with diabetes mellitus, tachycardia, alopecia, and gastrointestinal upset and on prolonged use of propranolol tablet had increased risk of incident gout.

Artesunate/Amodiaquine-Induced Acute Extrapyramidal Reactions in Children and Younger Adults: Case Series Assessment.

INTRODUCTION: Several studies conducted in African countries reported the artesunate and amodiaquine (AS/AQ) tablet as a safe and well-tolerated anti-malarial drug in children and younger adults. The aim of this case series assessment was to assess the causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults and to investigate the factor(s) predisposing to the adverse drug reactions. METHODS: The causal relationship of all the cases was first assessed individually using the Naranjo Probability Scale and then subjected to a case series assessment using Austin Bradford-Hill criteria. RESULTS: A total of 43 acute extrapyramidal reactions associated with the AS/AQ tablet were reported between 2012 and 16 November, 2015 to the Eritrean Pharmacovigilance Centre. The causality was found to be probable or highly probable for 33 (76.7 %) of the cases and the rest (10; 23.3 %) of the cases had a possible causal association. The extrapyramidal reactions had more or less similar clinical features in most of the cases and were characterized by abnormal involuntary contractions of muscles. The median age and body weight of the cases were 15 years and 40 kg, respectively, and 70 % of them were males. 90.7% of the reactions manifested in children and younger adults (aged <26 years). In most of the cases, reactions manifested in the third day from the start of treatment and 88.3 % of cases were hospitalized. CONCLUSION: The causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults was found to be apparent and possibly owing to dose accumulation or an overdose of amodiaquine.