Anti-malarial drug safety information obtained through routine monitoring in a rural district of South-Western Senegal

Brasseur, Philippe; Vaillant, Michel; Olliaro, Piero

doi:10.1186/1475-2875-11-402

Cited by 16 publications

(10 citation statements)

References 12 publications

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“…However, the study population was different from that of this study, being exclusively urban and predominantly adult (66.1% aged ≥13 years) and the anti-malarial treatment was not restricted to a specific anti-malarial medicine (43% of treatments were free or fixed combinations of AS and AQ, all brands considered). In a CEM study of patients treated with AS and AQ combinations (various free or fixed formulations over time) in rural Senegal, performed between 2001 and 2009 [24], patients were required to return to the HC every day for the 4 days following start of treatment and again after 4 weeks, where data on AEs were collected using a structured questionnaire. The rate of AEs reporting in the study (12%) is close to that observed in the present study in Côte d’Ivoire.…”

Section: Discussionmentioning

confidence: 99%

“…The identification of three characterized cases in this study prompted the Marketing Authorization Holder for ASAQ Winthrop ® to carry out a comprehensive assessment of the association of extrapyramidal disorders with ASAQ Winthrop ® or other anti-malarial drugs in 2012, which led to extrapyramidal disorders being listed as adverse drug reactions in the prescribing information for ASAQ Winthrop ® . Around the same time, an analysis was published of some of the earlier pharmacovigilance reports documented in the WHO global pharmacovigilance database (VigiBase™) [29], and there have been further subsequent reports of extrapyramidal symptoms in patients taking artemisinin and amodiaquine combinations elsewhere in Africa [23, 24, 30]. …”

Section: Discussionmentioning

confidence: 99%

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Safety of a fixed-dose combination of artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in real-life conditions of use in Côte d’Ivoire

Assi

Thomas

Yavo

et al. 2017

Malar J

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BackgroundIn many malaria-endemic, sub-Saharan African countries, existing pharmacovigilance systems are not sufficiently operational to document reliably the safety profile of anti-malarial drugs. This study describes the implantation of a community-based pharmacovigilance system in Côte d’Ivoire and its use to document the safety of ASAQ Winthrop® (artesunate–amodiaquine).MethodsThis prospective, longitudinal, descriptive, non-comparative, non-interventional study on the use of artesunate–amodiaquine in real-life conditions of use was conducted in seven Community Health Centres of the Agboville district in Côte d’Ivoire. Twenty trained Health Centre employees and 70 trained community health workers were involved in data collection in the field. All patients with suspected uncomplicated falciparum malaria, seeking treatment at one of the participating Health Centres, and treated with artesunate–amodiaquine could be enrolled. Two visits were planned, one for inclusion at the Health Centre and a second at home, performed by a community health worker 3–10 days after the inclusion visit. Administration of artesunate–amodiaquine was unsupervised. Adverse events (AEs) were documented at the home visit or during any unexpected visit to the Health Centre or to the hospital and coded and adjudicated by a local pharmacovigilance committee. Symptoms suggestive of hepatic failure, severe neutropaenia, extrapyramidal disorders and retinopathy were considered a priori as AEs of special interest.ResultsSome 15,228 malaria episodes in 12,198 patients were evaluated; 2545 AEs were documented during 1978 malaria episodes (13.0%). The most frequently observed events were asthenia (682 cases), vomiting (482 cases) and somnolence (174 cases). Most reported AEs were of mild or moderate intensity and resolved without corrective treatment. One-hundred and five (105) AEs reported during 100 episodes (0.7%) were considered as serious. Three serious cases of transient extrapyramidal disorders, identified as AEs of special interest were reported in three patients.ConclusionThe fixed dose artesunate–amodiaquine combination ASAQ Winthrop® for the unsupervised treatment of uncomplicated falciparum malaria under real-life conditions of care in Côte d’Ivoire is well tolerated. The study emphasizes the interest of involving properly trained community health workers to collect pharmacovigilance data in the field in order to document rare AEs.Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-016-1655-1) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Safety of a fixed-dose combination of artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in real-life conditions of use in Côte d’Ivoire

Assi

Thomas

Yavo

et al. 2017

Malar J

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“…Practical handbooks have been published by the WHO on how to conduct CEM in public health programmes for malaria, HIV/AIDS and tuberculosis [5–7]. Several CEM programmes have published their results from monitoring selected ACTs [10–13], and one CEM programme has recently published preliminary results from monitoring antiretrovirals [14]. Related publications identify challenges for implementing pharmacovigilance in resource-constrained settings [15] and propose strategies to complement spontaneous reporting for monitoring the safety of medicines in public health programmes [7].…”

Section: Introductionmentioning

confidence: 99%

Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey

Suku

Hill

Sabblah³

et al. 2015

Drug Saf

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IntroductionCohort event monitoring (CEM) is an intensive method of post-marketing surveillance for medicines safety. The method is based on prescription event monitoring, which began in the 1970s, and has since been adapted by WHO for monitoring the safety of medicines used in Public Health Programmes. CEM aims to capture all adverse events that occur in a defined group of patients after starting treatment with a specific medicine during the course of routine clinical practice.ObjectiveThe aims of this study were to describe the experiences of National Pharmacovigilance Centres (NCs) that have used CEM to monitor artemisinin-based combination therapy (ACT) for uncomplicated malaria in the African setting, to raise awareness of some of the challenges encountered during implementation and to highlight aspects of the method that require further consideration.MethodA questionnaire-based survey was conducted to capture the experiences of NCs that have implemented CEM for active post-marketing surveillance of antimalarial medicines in sub-Saharan Africa. Six NCs were identified as having implemented CEM programmes and were invited to participate in the survey; five NCs indicated willingness to participate and were sent the questionnaire to complete.ResultsFour NCs responded to the survey—Ghana, Kenya, Nigeria and Zimbabwe—providing information on the implementation of a total of six CEM programmes. Their experiences indicate that CEM has helped to build pharmacovigilance capacity within the participating NCs and at the monitoring sites, and that healthcare providers (HCPs) are generally willing to participate in implementing the CEM method. All of the programmes took longer than expected to complete: contributing factors included a prolonged enrolment period and unexpectedly slow data entry. All of the programmes exceeded their budget by 11.1–63.2 %. Data management was identified as a challenge for all participating NCs.ConclusionsThe reported experiences of four NCs that have undertaken CEM studies on ACTs indicate that CEM has helped to build pharmacovigilance capacity within NCs and monitoring sites and that HCPs are willing to participate in CEM programmes; however, the method was found to be labour intensive and data management was identified as a challenge. Reducing the workload associated with CEM, particularly in relation to data management, and integrating the method into the routine work of HCPs and NCs should be considered for future implementation.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-015-0331-7) contains supplementary material, which is available to authorized users.

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“…Amodiaquine-associated asthenia is a complaint of some users of amodiaquine and amodiaquine containing ACTs. In 2012, Brasuer et al reported an incidence of 17% of asthenia in 1,380 subjects who received amodiaquine-artesunate combination therapies [13]. Reports from Nigeria put the frequency between 5% and 36% with a lower incidence reported in children [12,14].…”

Section: Epidemiologymentioning

confidence: 99%

Amodiaquine-Associated Asthenia: A Case Based Review and Gaps in Literature

Michael

Badejo

Bakre

et al. 2016

ijtmgh

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Introduction: Amodiaquine is a partner drug in the artemisinin-based combination therapy artesunate-amodiaquine. Reports of the adverse drug reaction known as amodiaquine-associated asthenia are scarce, and this adverse reaction needs to be investigated in detail. This article presents and reviews a case of amodiaquine-associated asthenia. A literature search for the characteristics of this adverse reaction highlighted gaps in the literature. Methods: A case of probable amodiaquine asthenia was described and discussed under the sub-headings of epidemiology, clinical features, laboratory features, aetiopathogenesis, and management. A literature search limited to Medline Health Databases (Medline and PubMed Central, PMC) using the search terms and was conducted on 10 March 2015. Retrieved literature on the subject was closely scrutinized for relevant details of adverse drug reactions to amodiaquine when used in the management or prophylaxis of malaria. Cited literature within retrieved manuscripts was examined manually for other relevant literature. Papers retrieved from the search were used to describe the existing knowledge and gaps in it of the adverse drug reaction under sub-categories of incidence, clinical features, laboratory features, aetiopathogenesis, and management. Results: Thirty-nine manuscripts were retrieved; 20 had content relevant to the objectives of this review. The frequency of amodiaquine-associated asthenia in different populations ranged from 12-36%. There is a paucity of reports, and no detailed study of this adverse reaction has been published in popular English medical literature. Conclusion: With the use of amodiaquine as a partner drug in antimalarial combination therapies being scaled up, well-structured studies are needed on adverse reactions to amodiaquine and to investigate amodiaquine-associated asthenia. In addition, approaches to elucidating this adverse reaction more effectively in children need to be developed.

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Anti-malarial drug safety information obtained through routine monitoring in a rural district of South-Western Senegal

Cited by 16 publications

References 12 publications

Safety of a fixed-dose combination of artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in real-life conditions of use in Côte d’Ivoire

Safety of a fixed-dose combination of artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in real-life conditions of use in Côte d’Ivoire

Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey

Amodiaquine-Associated Asthenia: A Case Based Review and Gaps in Literature

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