Center National Of Pharmacovigilance

Tunis, Tunisia

Center National Of Pharmacovigilance

Tunis, Tunisia

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Fakhfakh R.,National Health Research Institute | Fakhfakh R.,National Institute of Public Health | Jellouli M.,National Health Research Institute | Klouz A.,Center National Of Pharmacovigilance | And 4 more authors.
Journal of Maternal-Fetal and Neonatal Medicine | Year: 2011

Objective. The validity of self-reported smoking in population surveys remains an important question yet to be answered. This has been of particular concern in a situation where there is a strong social pressure against pregnant and postpartum women. An associated question is what would be the value of measuring urinary cotinine concentrations in such surveys to obtain validated smoking data. Methods. Cross-sectional analysis of data on self-reported smoking and urinary cotinine among a sample of 398 pregnant women and recently pregnant, mothers of infants under the age of 2 months, who came to the Family Planning Clinic in Tunis urban area for either prenatal or newborn care. We used quantitative colorimetric urine test based on the könig reaction, in which pink-red chromophores formed from nicotine and its metabolites condensation with barbituric acid were extracted into acetate buffer. Results. The smoking prevalence among Tunisian pregnant women or mothers of newborn infants was 4%. The validity of self-reported daily smoking was relatively low. Among women reporting no smoking at the interview 16% misreported active smoking. According to urinary cotinine values, the smoking prevalence was 18.8%. Conclusions. These results substantiate the unreliability of self-report on smoking status among women in prenatal and postnatal period and have implications in clinical and education practice. © 2011 Informa UK, Ltd.


Kastalli S.,Center National Of Pharmacovigilance | El Aidli S.,Center National Of Pharmacovigilance | Zaiem A.,Center National Of Pharmacovigilance | Ben Abdallah H.,Military Hospital | Daghfous R.,Center National Of Pharmacovigilance
Fundamental and Clinical Pharmacology | Year: 2010

Clopidogrel, an adenosine diphosphate receptor blocker, is widely used as an adjunctive antiplatelet therapy in acute coronary syndrome and percutaneous coronary stenting. It appears to be a safe drug with few occurrences of liver side-effects that usually resolved after drug withdrawal. We report a serious liver injury with fatal outcome in a 63-year-old man developed 19 days after starting clopidogrel for percutaneous coronary stenting. © 2009 Société Française de Pharmacologie et de Thérapeutique.


Kastalli S.,Center National Of Pharmacovigilance | El Aidli S.,Center National Of Pharmacovigilance | Mourali S.,Service de Cardiologie Hopital La Rabta | Zaiem A.,Center National Of Pharmacovigilance | And 2 more authors.
Fundamental and Clinical Pharmacology | Year: 2012

Cardiac adverse effects have never been reported with interferon (INF) beta. We report a case of left bundle branch block in a 35-year-old woman treated with INF beta-1a for multiple sclerosis. Five years after INF therapy, she presented loss of consciousness, retrosternal pains, short breath and lowered tolerance of effort. ECG and Holter 24-h ECG monitoring revealed permanent complete left bundle branch block. Nine months after stopping INF, no abnormalities were found at ECG and echocardiogram examination. © 2011 The Authors Fundamental and Clinical Pharmacology © 2011 Société Française de Pharmacologie et de Thérapeutique.


Salouege I.,Center National Of Pharmacovigilance | Ali R.,Center National Of Pharmacovigilance | Said D.,Center National Of Pharmacovigilance | Elkadri N.,Service de Medecine Nucleaire | And 3 more authors.
Journal of Cancer Research and Therapeutics | Year: 2014

Objectives: This work is aimed on the study of doxorubicin cardiotoxicity and hepatotoxicity in rats and the evaluation of protective effect of trimetazidine administrated concomitantly with doxorubicin for 3 days. Materials and Methods: Male Wistar rats used were subjected to different types of treatment (3 days); A: Control, B: Doxorubicin treatment and C: Trimetazidine and doxorubicin treatment. After sacrifice, tissular distribution of doxorubicin, cardiac scintigraphy, histological examination of the myocardium, and evaluation of liver function were assessed. Results: Obtained results show that doxorubicin has a high affinity to tissues especially the heart. It causes hepatotoxicity and cardiotoxicity marked by a significant increase of aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) levels and drop of the left ventricular ejection fraction (EF LV ) by scintigraphy. Histological examination showed general alteration of myocardium structure. Concomitant administration of trimetazidine attenuates significantly the cardiotoxicity and hepatotoxity induced by doxorubicin. Conclusion: We have evaluated the protective effect of trimetazidine on an animal model of doxorubicin-induced cardiotoxicity and hepatotoxicity. The evaluation of these effects were assessed by several means; tissular distribution of doxorubicin, histological examination, assessment of liver function, and EF LV by scintigraphy that characterizes the originality of this study.


PubMed | Center National Of Pharmacovigilance
Type: Journal Article | Journal: Journal of cancer research and therapeutics | Year: 2014

This work is aimed on the study of doxorubicin cardiotoxicity and hepatotoxicity in rats and the evaluation of protective effect of trimetazidine administrated concomitantly with doxorubicin for 3 days.Male Wistar rats used were subjected to different types of treatment (3 days); A: Control, B: Doxorubicin treatment and C: Trimetazidine and doxorubicin treatment. After sacrifice, tissular distribution of doxorubicin, cardiac scintigraphy, histological examination of the myocardium, and evaluation of liver function were assessed.Obtained results show that doxorubicin has a high affinity to tissues especially the heart. It causes hepatotoxicity and cardiotoxicity marked by a significant increase of aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) levels and drop of the left ventricular ejection fraction (EF LV ) by scintigraphy. Histological examination showed general alteration of myocardium structure. Concomitant administration of trimetazidine attenuates significantly the cardiotoxicity and hepatotoxity induced by doxorubicin.We have evaluated the protective effect of trimetazidine on an animal model of doxorubicin-induced cardiotoxicity and hepatotoxicity. The evaluation of these effects were assessed by several means; tissular distribution of doxorubicin, histological examination, assessment of liver function, and EF LV by scintigraphy that characterizes the originality of this study.


PubMed | Center National Of Pharmacovigilance
Type: Journal Article | Journal: Therapie | Year: 2013

The objective of our work is to search if there is a relation between azathioprines metabolites (6-thioguanines nucleotides and 6-methyl mercaptopurines) and clinical efficacy and adverse effects of azathioprine in inflammatory bowel disease population.We included patients with Crohns disease or ulcerative colitis (UC) treated by azathioprine for a duration more than 1 year. Each patient had a dosage of azathioprine metabolites.We included 43 Crohns disease patients and 7 UC. Azathioprine was indicated for steroid dependancy in 23 cases, to prevent post-operative recurrence in 10 cases, to maintain clinical remission obtained by medical treatment in 17 patients. A clinical response to azathioprine (obtention of remission, absence of recurrence during the follow up) was observed in 34 patients.Our work confirms the relation between the doses of azathioprine metabolites and the myelotoxicity due to this molecule.


PubMed | Center National Of Pharmacovigilance
Type: Journal Article | Journal: Clinics and research in hepatology and gastroenterology | Year: 2012

The aim of this study was to determine the frequencies of TPMT and ITPA polymorphisms in Crohns disease patients of Tunisian origin and to compare them with allele frequencies previously reported in other populations of various ethnic origins.ITPA (c.94C>A and IVS2+21A>C) and TPMT (c.238G>C, c.460G>A and c.719A>G) mutations and genotypes were assessed in 208 Tunisian subjects (78 males/130 females) by polymerase chain reaction-restriction fragment length polymorphism and allele-specific-PCR methods.Genotyping of ITPA revealed frequencies of 6% and 7.9% for c.94C>A and IVS2+21A>C, respectively. Accordingly, deficient or diminished ITPA phenotype can be predicted to concern 2.4% of Tunisians. The observed frequencies of the c. 238G>C, c.460G>A and c.719A>G TPMT polymorphisms were 0, 0.24 and 1.44%, respectively.This study provides the first analysis of TPMT and ITPA mutant allele frequency in individuals of Tunisian origin. Unlike in Caucasians, TPMT*3C which harbours the c.719A>G polymorphism appears to be the most common mutant allele in Tunisians. In contrast, ITPA mutant allele frequency distribution appears to be similar to that observed in Caucasians.


PubMed | Center National Of Pharmacovigilance
Type: Case Reports | Journal: Fundamental & clinical pharmacology | Year: 2012

Cardiac adverse effects have never been reported with interferon (INF) beta. We report a case of left bundle branch block in a 35-year-old woman treated with INF beta-1a for multiple sclerosis. Five years after INF therapy, she presented loss of consciousness, retrosternal pains, short breath and lowered tolerance of effort. ECG and Holter 24-h ECG monitoring revealed permanent complete left bundle branch block. Nine months after stopping INF, no abnormalities were found at ECG and echocardiogram examination.


PubMed | Center National Of Pharmacovigilance, Tunis el Manar University and Manouba University
Type: Comparative Study | Journal: Annales de biologie clinique | Year: 2015

Ciclosporine (CsA) is an immunosuppressant drug used in bone marrow transplantation in order to extend allograft survival. Despite its efficiency, CsA can expose to therapeutic failure or to toxicity because of underdosing or overdosage. So, many techniques of monitoring CsA in blood were used, the referance one is the chromatographic technique then, the automated techniques: fluorescence polarization immunoassay (FPIA) and chimiluminescent microparticle immunoassay (CMIA). In this study, we aimed to compare the results of CsA concentrations measured by the two automised techniques. Statistical studies showed that the two techniques were repeatable and reproductible. Results obtained by FPIA were slightly higher than those obtained by CMIA but without a significative difference. In conclusion, FPIA technique could be used to measure CsA blood concentration in replacement of CMIA in case of technical problems.


PubMed | University of Tunis and Center National Of Pharmacovigilance
Type: Case Reports | Journal: Therapie | Year: 2014

Vancomycin penetrates poorly through the blood-brain barrier. Determination of vancomycin concentration in plasma is recommended. In contrast, its determination in cerebrospinal fluid (CSF) is rarely performed. We report the case of a 74-year-old man with post traumatic meningitis with vancomycin concentration measured in CSF.

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