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Mehta U.,University of Cape Town | Dheda M.,Pharmacovigilance Unit | Steel G.,NDoH | Blockman M.,University of Cape Town | And 4 more authors.
South African Medical Journal | Year: 2014

This report outlines findings and recommendations of a national pharmacovigilance workshop held in August 2012 in South Africa (SA). A survey of current pharmacovigilance activities, conducted in preparation for the meeting, identified multiple programmes collecting drug safety data in SA, with limited co-ordination at national level. The meeting resolved that existing pharmacovigilance programmes need to be strengthened and consolidated to ensure that important local safety issues are addressed, data can be pooled and compared and outputs shared more widely. Pharmacovigilance activities should inform treatment guidelines with the goal of improving patient care. A variety of pharmaco-epidemiological approaches should be employed, including nesting drug safety studies within existing sentinel cohorts and the creation of a pregnancy exposure registry. The attendees agreed on key principles that will inform a national pharmacovigilance plan and compiled a list of priority pharmacovigilance issues facing public health programmes in SA. Source


Hunt J.R.,University of Bristol | Dean R.S.,University of Nottingham | Davis G.N.D.,Pharmacovigilance Unit | Murrell J.C.,University of Bristol
Veterinary Journal | Year: 2015

This study aimed to analyse UK pharmacovigilance data to quantify adverse events (AEs) associated with the non-steroidal anti-inflammatory drug (NSAID) molecules found in veterinary medicines authorised for use in dogs and cats. It was hypothesised that the frequency of AEs would be lower when associated with cyclo-oxygenase-2 selective (coxib), compared to non-selective (non-coxib) NSAIDs. The UK Veterinary Medicines Directorate (VMD) supplied frequencies of AEs derived from Periodic Safety Update Reports subdivided by formulation and species for each NSAID molecule.Frequencies of AEs were similar between species. The five most reported AEs were emesis, death, anorexia, lethargy, and diarrhoea. Reported frequency of emesis, renal insufficiency and death was higher with injectable compared to oral NSAIDs (. P = 0.043). Reported frequency of emesis, lethargy and death was higher with coxib, compared to non-coxib NSAIDs (. P = 0.029). Median (range) interval since authorisation was shorter for coxibs at 5 (2.5-9) years compared to non-coxibs at 15 (12-25) years. A negative correlation between time elapsed since authorisation and the frequency of AEs was identified (. rs = -0.11 to -0.94). Higher frequency of reported AEs with injectable NSAIDs may be related to perioperative administration. The AE frequency associated with coxib and non-coxib NSAIDs may be confounded by changes in reporting habits over time.This study highlights the value of interrogating passive surveillance data to identify low frequency AEs and the need to facilitate improvement in recording and collecting AEs in small animal practice. © 2015 Elsevier Ltd. Source


Olszanecka-Glinianowicz M.,Medical University of Silesia, Katowice | Smertka M.,Medical University of Silesia, Katowice | Almgren-Rachtan A.,Pharmacovigilance Unit | Chudek J.,Medical University of Silesia, Katowice
Pharmacological Reports | Year: 2014

Background Overweight and obesity decrease the effectiveness of antihypertensive therapy despite the more frequent use of polytherapy. One method for improving therapy effectiveness is by decreasing non-compliance with the use of fixed-dose combinations (FDC). The aim of this study was to assess the effectiveness, tolerance, and satisfaction with ramipril/amlodipine FDC antihypertensive therapy in relation to nutritional status. Methods The survey enrolled 24,240 hypertensive patients recently switched to ramipril/amlodipine FDC (EGIRAMLON) at the same doses as previously prescribed separate pills. Results The effectiveness of antihypertensive therapy increased during follow-up from 32.9% to 76.5%. Overweight and obesity were associated with the increased risk of not attaining the recommended BP values [adjusted for age OR = 0.74 (95% CI 0.67-0.83) and 0.70 (0.61-0.81) for overweight; 0.54 (0.47-0.60) and 0.49 (0.42-0.57) for obese, at the first and the second examination, respectively]. "Very good" or "good" the FDP tolerance was reported by 98.8%, 97.6% and 96.4%, respectively. Adverse events (AE) were reported in 0.35% of patients regardless of nutritional status. High levels of satisfaction with the FDC were reported by 57.0% of patients with normal weight, 54.5% of overweight, and 50.6% with obesity. Effectiveness and convenience were the most important for patients. Conclusions The effectiveness of therapy with ramipril/amlodipine FDC in the study population was high, but slightly lower in overweigh and obese. This FDC was well tolerated and a significant number of patients satisfied with the therapy regardless of nutritional status. Although the perceived tolerance and satisfaction with treatment were lower in obese and overweight than in normal weight patients; the incidence of AE and perceived benefit from the use of a single-pill, compared to multiple tablets, were comparable irrespective of nutritional status. © 2014 Institute of Pharmacology, Polish Academy of Sciences. Source


Dridi I.,University of Monastir | Ben-Cherif W.,University of Monastir | Aouam K.,University of Monastir | Ben-Attia M.,University of Carthage | And 3 more authors.
European Journal of Pharmaceutical Sciences | Year: 2014

The present work aims to investigate whether the pharmacokinetics of the active metabolite mycophenolic acid (MPA) varies according to the circadian dosing-time of mycophenolate mofetil (MMF). A total of 180 male Wistar rats aged 8 weeks and synchronized for 3 weeks to 12 h light and 12 h dark were used. A single dose of 200 mg/kg of MMF was administrated in rats by i.p route at either of the four different circadian stages (1, 7, 13, and 19 Hours After Light Onset, HALO) (45 rats/circadian time). At each circadian stage, blood samples were collected at 5, 10, 15, 20, 30 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h and 24 h following drug injection. Plasma MPA concentrations were analyzed for each sample using a validated high-performance liquid chromatography (RP-HPLC) method. Tmax of MPA remained similar whatever the circadian time of injection mean Tmax = 30 min). However, the peak of plasma concentration Cmax varied significantly according to the circadian dosing-time. Maximum and minimum Cmax were obtained when MMF was injected at 7 HALO (69.1 μg/ml) and at 19 HALO (22.7 ± 1.74 μg/ml) respectively. AUC0-24 varied significantly according to the circadian-time of injection (166.33 ± 10.54 mg h/L at 7 HALO vs 80.27 ± 2.33 mg h/L at 19 HALO) (p < 0.05). The highest and lowest mean values of plasma clearance (CL calculated as Dos/AUC) were observed at 19 HALO (2.45 ± 0.07 L/h/kg) and at 7 HALO (1.08 ± 0.06 L/h/kg) respectively (p < 0.05). Cosinor showed a circadian rhythm in the pharmacokinetic parameters Cmax, AUC 0-24 and plasma clearance. The mechanism of circadian rhythm in MMF tolerance might be partly explained by the circadian variation of pharmacokinetics since the time (7 HALO) of maximum hematological and digestive toxicity corresponds to that of the lowest plasma clearance on the highest Cmax and AUC0-24 of MMF. © 2014 Elsevier B.V. All rights reserved. Source


Teil J.,Pharmacy | Dupont D.,Institute Of Parasitologie Mycologie Medicale | Dupont D.,University Claude Bernard Lyon 1 | Charpiat B.,Pharmacy | And 6 more authors.
Pediatric Infectious Disease Journal | Year: 2016

Background: The treatment of newborns and infants with congenital toxoplasmosis is standard practice. Some observational studies have examined safety in newborns, but most of these failed to provide sufficient details for a provisional assessment of causality. The aim of this study was to evaluate the clinical and biological adverse effects of the combination of sulfadoxine- pyrimethamine. Methods: Sixty-five children treated for 1 year with a combination of sulfadoxine- pyrimethamine (1 dose every 10 days) for congenital toxoplasmosis were followed up to evaluate abnormal hematological values and potential adverse events using a standardized method of causality assessment. Results: Nine patients (13.8%) presented at least 1 adverse clinical event that was nonspecific, such as diarrhea on the day of drug administration, vomiting and agitation. In 1 patient, erythema appeared at the end of the treatment and resolved within 10 days. None of these events was attributed to the treatment. Six patients (9.2%) developed an adverse hematological event (neutropenia, n = 3; eosinophilia, n = 2 and both anemia and eosinophilia, n = 1) that was considered to be possibly related to the sulfadoxine- pyrimethamine combination. Four treatments were temporarily interrupted, and toxicity was observed after readministration of treatment in 1 case only. However, none of these adverse events was life threatening. Conclusions: According to our results and previously published data, the combination of sulfadoxine-pyrimethamine seems to be well tolerated. However, the sample size of our study was too small to rule out the risk of less frequent, but nevertheless severe, reactions and, in particular, of hypersensitivity reactions. copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. Source

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