WHO information note indicates that isoniazid preventive therapy (IPT) is generally safe with little risk of hepatotoxicity. However, when the policy of IPT for HIV patients was introduced in Eritrea, frequent IPT‐associated hepatotoxicity and fatality have been reported to the Pharmacovigilance Centre. The aim of the study is to assess the causal association of IPT and hepatotoxicity and identify possible risk factors in patients on Highly Active Anti‐retroviral Therapy (HAART). This is a case series assessment of spontaneously reported cases to the Eritrean Pharmacovigilance Centre. Data extracted from VigiFlow (reported between 2014 and 2016) were exported to excel spread sheet for descriptive and qualitative analysis. Naranjo probability scale and Austin Bradford‐Hill criteria were used to assess causality. The P‐Method was used to assess preventability. A total of 31 of cases of hepatotoxicity related to IPT were retrieved. Majority (80.6%) of the cases were marked as “serious” due to life‐threatening situation (n = 15), hospitalization (n = 6), and death (n = 4). Baseline liver function test was normal in 61.3% and hepatitis B and C infections were ruled out in 77.4%. IPT was discontinued in 26 cases and reaction abated in 22 of them. Causality assessment using Austin Bradford‐Hill criteria found that the association was strong, consistent and specific with a plausible temporal relationship and biological mechanism. IPT‐associated hepatotoxicity that led to treatment interruption and death was observed in patients on HAART in Eritrea. Hence, close laboratory monitoring of patients is recommended to minimize the risk.

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ObjectiveTo measure knowledge, attitude and practice of antibiotics and antibiotic resistance (ABR) and their determinants in the Eritrean urban population.DesignA population-based, nation-wide, cross-sectional study.SettingUrban settings of Eritrea.ParticipantsMembers of the general public aged ≥18 years and living in 13 urban places of Eritrea. Three-stage stratified cluster sampling was used to select the study participants.Data collection and analysisDate were collected from July 2019 to September 2019 in a face-to-face interview using a structured questionnaire. The collected data were double entered and analysed using Census and Survey Processing system (V.7.0) and SPSS (V.23), respectively. Descriptive statistics, χ2 test, t-tests, analysis of variance, factorial analysis and multivariable logistic regression were performed. All analyses were weighted and p<0.05 was considered significant.Primary and secondary outcome measuresMain outcome variables were knowledge, attitude and practice of antibiotics and ABR. Secondary outcome measure was the determinants of knowledge, attitude and practice.ResultsA total of 2477 adults were interviewed. The mean score of knowledge and attitude of antibiotics and ABR was 10.36/20 (SD=3.51, minimum=0 and maximum=20) and 22.34/30 (SD=3.59, minimum=6 and maximum=30), respectively. Of those who used antibiotics, the proportion of at least one inappropriate practice (use of antibiotics without prescription and/or discontinuation of prescribed antibiotics before completing the full course) was 23.8%. Young age <24 years (adjusted odds ratio (AOR)=1.61, 95% CI: 1.08 to 2.41), male sex (AOR=1.48, 95% CI: 1.14 to 1.91), higher level of education (AOR=1.76, 95% CI: 1.08 to 2.88), and negative attitude towards appropriate use of antibiotics (AOR=0.95, 95% CI: 0.92 to 0.97) were found to be the significant determinants of inappropriate practice of antibiotics.ConclusionThe gap in knowledge and inappropriate practice of antibiotics in the Eritrean urban population was widespread; requiring immediate attention from policy-makers and healthcare professionals.

Introduction Praziquantel has been in use by helminthiasis and schistosomiasis control programs for about 30 years. Although deemed to be safe with regard to its adverse drug reaction profile in reference to the product information of Biltricide, the Eritrean Pharmacovigilance Center received reports of visual abnormalities related to the drug. This is a case series assessment of unusual cases of visual abnormalities associated with praziquantel. Methods Search was made in VigiBase by setting praziquantel as a drug substance, Eritrea as the reporting country and all eye disorders, high level term (HLT) to capture all visual disorders associated with Praziquantel. The retrieved dataset was exported into an Excel spreadsheet for descriptive analysis and causality was assessed using Austin Bradford-Hill criteria. Results There are a total of 2579 Individual Case Safety Reports (ICSRs) of various Adverse Drug Reactions (ADRs) of praziquantel reported from Eritrea in VigiBase. The 61 reports of visual abnormalities that arose within the first 24 hours of praziquantel administration are of note. With a strong association as evidenced by the positive IC 025 value, the association of praziquantel and blurred vision was consistently reported from different health facilities over a period of three years. It is a specific association in terms of both the exposure (only praziquantel) and the outcome (blurred vision) as reported in majority of the cases. However, experimental evidences for the association are lacking, the underweight profile of the Eritrean population suggests overdosing as a possible risk factor for the occurrence of these reactions. Conclusion The strength, temporal plausibility, consistency and specificity of the association are suggestive of a causal association between praziquantel and visual disorders.

Tamsulosin hydrochloride, a selective alpha‐adrenergic blocking agent has been previously associated with priapism. Priapism is a medically serious condition that, if not intervened, can cause permanent erectile dysfunction. This study was conducted to investigate whether the association of tamsulosin and priapism is causal. All currently available evidence such as experimental, biological, toxicological, published studies, and safety data mined from the WHO global pharmacovigilance database was systematically organized into the Austin Bradford Hill causality assessment framework. In the international pharmacovigilance database, a strong association between tamsulosin and priapism (IC025 = 4.1; PRR025 = 19.9; ROR025 = 20) was observed. There were 122 cases of priapism associated with tamsulosin submitted to the database from 23 countries. In 87.7% of the cases, tamsulosin was reported as a ‘sole suspect,’ and in 50.8%, it was the only drug administered. In several patients, priapism resolved following discontinuation of tamsulosin and recurred after its reintroduction. Both in the published and unpublished data, for majority of the cases, the time to onset of priapism was within few days following the first intake of tamsulosin. Cases of priapism, particularly those published, were consistent in their clinical features with patients experiencing prolonged painful erection that required aspiration of cavernosal blood, irrigation of the corpora cavernosa, and treatment with vasopressors. Other alpha‐adrenergic blocking agents that are structurally analogous with tamsulosin have also been associated with priapism. In several cases, tamsulosin was used off‐label, for the treatment of ureteral calculi expulsion. Eight patients experienced priapism that ended up with serious complications such as ejaculation disorders and erectile dysfunction. The currently available totality of evidence suggests that the association of tamsulosin and priapism is causal. Healthcare professionals are therefore recommended to cautiously prescribe tamsulosin and ensure that consumers are aware of the potential risk of priapism.