A prospective study of adverse drug reactions to artemisinin-based combination therapy in a tertiary care hospital in India

Belhekar, Mahesh N; Advani, Manjari; Pawar, Sudhir

doi:10.4103/0253-7613.93863

Cited by 6 publications

(4 citation statements)

References 8 publications

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“…This supports findings from China, Thailand, South East Asia and other African countries where ACTs have been used extensively and were found to be relatively safe and well tolerated . This is also in line with the prospective study of Belhekar et al who suggested that ADRs from ACTs were of moderate intensity with the ADRs most commonly reported when chloroquine was prescribed as concomitant drug. However, this study reveals that there is no statistically significant association between the use of suspect drugs and concomitant drugs in ADRs occurrence.…”

Section: Discussionsupporting

confidence: 90%

Patterns of adverse drug reaction signals in NAFDAC pharmacovigilance activities from January to June 2015: safety of drug use in Nigeria

Awodele

Aliu

Ibrahim

et al. 2018

Pharmacology Res & Perspec

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Adverse drug reactions (ADRs) are expected to be associated with an economic drain on the healthcare systems. The study was carried out to determine the occurrence of ADRs reported to NAFDAC Pharmacovigilance from January to June 2015, to illustrate the pattern of organ system affected by ADRs, to assess the completeness of ADR report, to determine the relationship between the occurrence of ADRs with suspect drugs and the use of concomitant drugs as well as to generate possible signals from the reported ADRs. A total number of 921 ADR cases reported from January to June 2015 were analyzed using SPSS version 22. A higher percentage of ADR reports were seen in females (65.5%). The highest percentages of reports (45.6%) were from the age range of 21‐40 years, most of the suspected drugs reported had both NAFDAC (50.2%) and batch number identification (65.6%). HIV (56.9%) was the most prevalent indication reported for using the suspected drug; Zidovudine/Lamivudine/Nevirapine combination (16.9%) was reported as the suspected drug with the highest occurrences of ADRs and generalized body itching (6.9%) as the most prevalent ADR. “General disorders” (47.3%) was the most predominant organ system affected by ADRs and Pharmacists were revealed as the highest reporters of ADRs (80.2%). Overall, patients on ARVs should be vigilantly followed up as they are mostly prone to ADRs. Adverse drug reaction reporting systems need to be robust and complete in order to be able to detect new drug alerts, possible signals and improve pharmacovigilance

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Section: Discussionsupporting

confidence: 90%

Patterns of adverse drug reaction signals in NAFDAC pharmacovigilance activities from January to June 2015: safety of drug use in Nigeria

Awodele

Aliu

Ibrahim

et al. 2018

Pharmacology Res & Perspec

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“…This is contrary to the findings of Belhekar [29] In the opinion of this paper, self-co-administration of analgesics and hematinics may indicate patient's anticipation of some sort of pain and "weakening of blood" which needs strengthening with hematinic. Another key finding is the influence of premedication fatty meal on ADR.…”

Section: Discussioncontrasting

confidence: 99%

Perceived Adverse Drug reactions to Artemether Lumefantrine and Artesunate Amodiaquine in Lagos, Nigeria

Afolabi¹,

Ogunwale²

2021

Am J Res Med Sci

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Introduction: Medications produce a therapeutic effect that modulates a disorder and unwarranted effects that may be intrinsically harmful. Adverse drug reactions (ADRs) are undesirable effects that results from drug administration at usual doses and are the primary focus of regulatory agencies and post-marketing surveillance. Aim and objectives: To evaluate ADRs to Artemisinin-based Combination Therapies (ACTs) such as Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AA) among adults with the objectives of (i) estimating and comparing the frequency of ADRs associated with AL and AA and (ii) developing a list of classical adverse drug reactions to both antimalarials. Materials and Methods: This cross-sectional, quantitative study was conducted from March to May 2013 at Ikorodu, a peri-urban settlement in Lagos State of Nigeria among 252 patients diagnosed with malaria and randomized into Artemether Lumefantrine (AL) arm and Artesunate Amodiaquine (AA) arm. Results: The mean age (years) of all the study subjects was 34.4 (10.6) with 58% of them who attained secondary level education. About 50% of them took other non-antimalarial medication together with prescribed ACT during their illness. Overall mean duration of illness (days) before taking ACT was 2.8 (1.14) which was significantly longer (t-est=-3.57, P-value=0.0002) in AA arm (3.1 ± 1.2) than in AL arm (2.6 ± 1.0). In all, 234 (96.4%) and 169 (67.1%) severally completed the full dose of treatment and ate pre-medication fatty meal. Overall prevalence of ADRs was 47.6% - 27.8% in the AL arm and 69.8% in the AA arm. Among those who did not take fatty meal, the risk of ADRs was higher (χ²=0.69, P-value=0.40, RR=1.26, 95% CI=0.72, 2.21) in the AA arm compared to the AL arm. Weakness, dizziness and headache were the most prevalent ADRs reported in both AL (25.9%, 13.8%, 15.5% respectively) and AA (50.0%, 10.0%, 16.4% respectively) arms. Conclusion: In general, the frequency of ADRs, though mild or moderate in severity, was significantly higher in the AA arm than in the AL arm and the frequency of serious ADR was very low. The most prevalent ADRs reported were weakness/fatigue, headache and dizziness. Pre-medication consumption of fatty meal reduced the frequency of ADRs in both arms of the study. Programmes on the management of malaria with ACT should consider this baseline information for active surveillance for ADRs in Nigeria.

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“…Interestingly, treatment with the fruit juice signi cantly increased (p 0.05) the PCV to a mean value comparable to the standard drug group. In clinical treatment of malaria infection particularly in pregnant women, blood tonics are usually prescribed in addition to the antimalarial drug [19,[70][71][72]. This is to replenish the lost RBC due to malaria infection whereas the critical antimalarial component clears the parasites.…”

Section: Discussionmentioning

confidence: 99%

Nutritional Intervention and Therapeutic Use of Azadirachta Indica (Neem) Fruit Juice as It Clears Malaria Parasites and Replenishes Depleted Blood Levels in Plasmodium Berghei Infected Swiss Albino Mice

IGWENYI,

ONODUGO,

AJA

et al. 2023

Preprint

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One of the major pathogenesis of malaria parasite infection is the invasion and destruction of the Red Blood Cells, which requires the synergistic administration of antimalarial and most times essential nutrients for effective treatment. Previous studies have shown that various non-edible parts of Azadirachta indica tree may have anti-malarial potentials, hence the investigation on the effects of edible fresh juice of Azadirachta indica fruit on various hematological parameters in addition to its potential to clear Plasmodium berghei in infected mice. The phytochemical constituents of A. indica fruit juice were carried out by Gas Chromatography-Mass Spectroscopic (GC-MS) method. Determinations of creatinine, urea, and lipid profile were carried out using Auto-analyzer. The chromatogram of GC-MS analysis of A. indica fruit juice showed four (4) peaks as follows dodecanoic acid (4.37%), oleic acid (14.19%), 13-octadecyl (17.05%) and 15-tetracosanoic acid methyl ester (47.13%) as the major constituent. The unique pathway for plasmodial fatty acid synthesis has become a possible target of drug action. Adult male mice were placed in six groups (n = 6). Group A mice were fed a normal diet and water ad libitum only while groups B to E were fed a normal diet and water ad libitum and further infected with Plasmodium berghei. The parasitemia was confirmed on the third day of infection. Groups C, D, E, and F were further given 5mg/kg body weight of Artesunate, 4.3ml/kg, 8.6 ml/kg, and 12.9 ml/kg of fruit juice respectively for fourteen days and then sacrificed. The percentage of parasitemia in infected groups was very high but treatment with Artesunate and various doses of fruit juice significantly reduced the percentage of parasitemia. Interestingly, 0.86mg/kg dose of the fruit juice caused a high significant reduction in the percentage of parasitemia comparable to the potency of Artesunate. Additionally, infection with Plasmodium berghei yielded a significant decrease in the levels of various hematological indices in the infected mice which were normalized with the administration of Artesunate and the fruit juice of Azadirachta indica. Fruit juice of Azadirachta indica has been shown to have novel dual benefits of clearing malaria parasites, serving as a blood tonic and nutritional supplement.

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A prospective study of adverse drug reactions to artemisinin-based combination therapy in a tertiary care hospital in India

Cited by 6 publications

References 8 publications

Patterns of adverse drug reaction signals in NAFDAC pharmacovigilance activities from January to June 2015: safety of drug use in Nigeria

Patterns of adverse drug reaction signals in NAFDAC pharmacovigilance activities from January to June 2015: safety of drug use in Nigeria

Perceived Adverse Drug reactions to Artemether Lumefantrine and Artesunate Amodiaquine in Lagos, Nigeria

Nutritional Intervention and Therapeutic Use of Azadirachta Indica (Neem) Fruit Juice as It Clears Malaria Parasites and Replenishes Depleted Blood Levels in Plasmodium Berghei Infected Swiss Albino Mice

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