Publications by authors named "Geneviève Mounier"

11 Publications

  • Page 1 of 1

Muscle Damage Due to Fusidic Acid-Statin Interaction: Review of 75 Cases From the French Pharmacovigilance Database and Literature Reports.

Am J Ther 2019 May/Jun;26(3):e375-e379

Internal Medicine Department, University Hospital of Saint-Etienne, Saint-Etienne, France.

Background/area Of Uncertainty: Statins, which reduce cardiovascular risk in both primary and secondary prevention, are one of the most widely prescribed therapeutic classes in the world. Usually well-tolerated, statin-associated muscle symptoms are a well-known adverse effect. Fusidic acid (FA) is a bacteriostatic antibiotic of interest in the treatment of methicillin-resistant Staphylococcus aureus infections. Cases of rhabdomyolysis, sometimes fatal, have been reported after coprescription of FA and a statin.

Data Sources/area Of Uncertainty: We studied 75 cases of muscle damage related to interaction between FA and a statin reported in the French national pharmacovigilance database (43 cases) and from a literature review (32 cases).

Results: Cases were mostly men (72.5%), often overweight (mean body mass index: 29.4). The most commonly reported statins were atorvastatin (60%), simvastatin (22.7%), and rosuvastatin (8.0%). Muscle disorders appeared on average 30 days after initiation of FA. Symptoms were muscle weakness (82%), dark urine (71%), and myalgia (61%). Mean creatine kinase level at diagnosis was 43,890 UI/mL, and acute renal injury occurred more than half of the cases. Outcome was fatal in 22% of cases and 28% kept sequelae at the end of the follow-up (54 days).

Conclusions: Muscle damage induced by interaction between FA and statin is a potentially life-threatening complication, leading to contraindication of this association in France. This is to be reminded especially because FA is about to get FDA approval and should soon be available in the United States.
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http://dx.doi.org/10.1097/MJT.0000000000000679DOI Listing
November 2019

[Not Available].

Therapie 2014 Nov-Dec;69(6):483-90

Centre de pharmacovigilance, Centre hospitalier universitaire de Saint-Étienne, Saint-Étienne - Hôpital Nord, France.

Aim: To evaluate the value of research in the case-mix database to identify cases of drug-related anaphylactic or anaphylactoid shock.

Methods: Hospital stays of patients discharged from the University Hospital of Saint-Étienne between July 1st 2009 and June 30th 2012. Five codes from the international classification of diseases were selected: T88.6, T88.2, J39.3, T80.5 and T78.2.

Results: Among 89 cases identified by the programme for medicalization of information system (programme de médicalisation des systèmes d'information, PMSI), 40 were selected (45%). Of these, 16 cases were spontaneously reported by physicians. The unspecific code "anaphylactic shock unspecified (T78.2)" was coded for 57.5% of cases.

Conclusion: The study confirms the interest of the PMSI as a tool for health monitoring, in addition to spontaneous reporting. Nevertheless, coding with insufficient precision about the causal role of the drug, requires a return to the medical record and so an important time consuming process.
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http://dx.doi.org/10.2515/therapie/2014057DOI Listing
July 2016

[Drug-related anaphylactic shocks: under-reporting and PMSI].

Therapie 2014 Nov-Dec;69(6):483-90. Epub 2014 Oct 1.

Centre de pharmacovigilance, Centre hospitalier universitaire de Saint-Étienne, Saint-Étienne - Hôpital Nord, France.

Aim: To evaluate the value of research in the case-mix database to identify cases of drug-related anaphylactic or anaphylactoid shock.

Methods: Hospital stays of patients discharged from the University Hospital of Saint-Étienne between July 1st 2009 and June 30th 2012. Five codes from the international classification of diseases were selected: T88.6, T88.2, J39.3, T80.5 and T78.2.

Results: Among 89 cases identified by the programme for medicalization of information system (programme de médicalisation des systèmes d'information, PMSI), 40 were selected (45%). Of these, 16 cases were spontaneously reported by physicians. The unspecific code "anaphylactic shock unspecified (T78.2)" was coded for 57.5% of cases.

Conclusion: The study confirms the interest of the PMSI as a tool for health monitoring, in addition to spontaneous reporting. Nevertheless, coding with insufficient precision about the causal role of the drug, requires a return to the medical record and so an important time consuming process.
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http://dx.doi.org/10.2515/therapie/2014057DOI Listing
February 2015

Efficacy of baclofen on abstinence and craving in alcohol-dependent patients: a meta-analysis of randomized controlled trials.

Therapie 2014 Sep-Oct;69(5):427-35. Epub 2014 Sep 18.

Centre régional de Pharmacovigilance de la Loire, Centre hospitalier et universitaire de Saint-Étienne, Saint-Étienne, France - EA3065, Groupe de recherche sur la thrombose, Université Jean-Monnet, Saint-Étienne, France.

Purpose: We conducted a meta-analysis in order to estimate the efficacy of baclofen on the maintenance of abstinence and the decrease of craving in alcohol-dependent patients.

Methods: All randomized controlled clinical trials assessing baclofen for at least four weeks' treatment duration versus placebo or other comparators were included. The primary outcome measure was the percentage of patients who had not consumed alcohol at the end of the treatment. Measures of cumulative abstinence and indexes of craving were also assessed.

Results: Compared to placebo, baclofen was associated with a significant increase of 179% in the percentage of abstinent patients at the end of the trial, without heterogeneity. For secondary outcome measures, based on a random-effect model, no significant effect of baclofen was observed compared to placebo.

Conclusions: Our meta-analysis brings weak support towards an efficacy of low dosages of baclofen on the maintenance of abstinence in alcohol-dependent patients.
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http://dx.doi.org/10.2515/therapie/2014038DOI Listing
February 2015

Complications of BCG vaccine SSI® recent story and risk management plan: the French experience.

Pharmacoepidemiol Drug Saf 2013 Apr 5;22(4):359-64. Epub 2012 Dec 5.

Department of Dermatology, CHU de Saint Etienne (Saint Etienne University Hospital), Saint Etienne, France.

Introduction: As of January 2006, the BCG vaccine SSI® became the only BCG vaccine available for tuberculosis vaccination in France. The use of this vaccine led to significant changes in vaccination technique which were accompanied by a rapid increase in the number of adverse reactions (ADRs) reported. A national pharmacovigilance follow-up began in February 2006, and a risk management plan (RMP) was put in place in April 2006, made of three phases (carried out in June 2006, July 2006 and September 2006) with risk minimisation measures. The goal of this study was to evaluate the impact of the RMP on the amount of ADRs reported.

Methods: Based on data collected by the regional pharmacovigilance centres and the MSD laboratory, the cases of locoregional ADRs spontaneously reported were analysed retrospectively from January 2005 to February 2006, and then prospectively up to June 2008, the date at which the national follow-up ended. The locoregional ADRs were divided into three categories: abscesses, local reactions or lymphadenopathy of more than 1 cm and suppurative lymphadenopathy. A parallel was then drawn between these data and the different phases of the RMP.

Results: During the entire follow-up period, we note 1050 locoregional ADRs, of which 764 were abscesses (73% of all cases), 266 were local reactions and 20 involved suppurative lymphadenopathy.Locoregional ADRs increased rapidly from January 2006 onward, reaching a peak in August 006 and then falling and stabilising from December 2007 onward.The RMP was implemented when there was an increase in the number of ADRs reported. The drop in the number of these effects began 3 months after the first phase and 2 months after the second phase of the RMP. The third phase was not accompanied by a variation in the number of ADRs reported.

Conclusion: The RMP appears to have positive effect on the evolution of the number of ADRs, their decrease occurring rapidly after the risk minimisation measures of the first two phases. Nonetheless, these data should be confirmed by other studies on the efficacy of RMPs.
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http://dx.doi.org/10.1002/pds.3383DOI Listing
April 2013

[Drug induced hyponatremia. About a series of 54 cases notified to the regional center of pharmacovigilance of Saint-Étienne].

Therapie 2011 Mar-Apr;66(2):139-48. Epub 2011 Jun 6.

Centre Regional de Pharmacovigilance, CHU de Saint-Etienne, Saint-Etienne, France.

Objective: Analyze the most frequently reported drug in iatrogenic hyponatremia, explaining the mechanism in question.

Methods: Retrospective study on 54 notified cases between the Jan.1(st) 2003 and Dec. 31(st) 2009. The analysis focuses on drug classes, accountability and mechanism; risk factors, severity and the evolution of the case.

Results: Fourty-nine cases have been retained, 75,5% of the time it was an inappropriate secretion of antidiuretic hormone (SIADH) involving a selective serotonin reuptake inhibitor (SSRI) in 15 cases, an anticonvulsant in 7 cases, a proton pump inhibitor (PPI) in 7 cases or other drugs in 11. The hypo-osmolar hypovolemic hyponatremia was 12.2% of cases, incriminating a thiazide diuretic once in two. The mechanism was different or indeterminate in 12.2% of cases. In 67% cases were serious. The evolution was often favourable.

Conclusion: Drug induced hyponatremia can be serious. It must control natremia with patients at risk or symptomatic and conduct the etiological diagnosis.
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http://dx.doi.org/10.2515/therapie/2011011DOI Listing
January 2013

Serious adverse reactions of bupropion for smoking cessation: analysis of the French Pharmacovigilance Database from 2001 to 2004.

Drug Saf 2008 ;31(11):1017-26

Regional Pharmacovigilance Centre, Bellevue Hospital University, Saint-Etienne Cedex 2, France.

Background: Bupropion was the first alternative to nicotine replacement therapy in the pharmacological treatment for smoking cessation. Its safety profile has been monitored in France via spontaneous reporting.

Objective: To describe all serious adverse reactions (SARs) reported in France since the marketing authorization for bupropion in September 2001, and to analyse risk factors for these SARs.

Design: We collected all spontaneous reports of adverse reactions to bupropion received by all French Regional Pharmacovigilance Centres and by GlaxoSmithKline, the manufacturer of bupropion, during the first 3 years of marketing of this agent. We identified the characteristics of the population to whom bupropion was prescribed from the Thales database, which contains information obtained from a representative sample of general practitioners in France. We then compared the population with SARs with the population prescribed the drug (exposed population) to identify possible risk factors such as sex, age and daily dose for the most frequent SARs.

Results: Bupropion was prescribed to 698 000 patients during the first 3 years of marketing in France. In these patients, 1682 cases of adverse reactions were reported; 28% of these involved SARs, mainly cutaneous or allergic reactions (31.2%), including angioedema and serum sickness-like reactions. Serious neurological reactions were frequent (22.5%), mostly comprising seizures; however, questioning revealed that almost half of these patients had a history of seizures or other risk factors. Of the serious neuropsychiatric adverse events reported (17.3%), suicide attempts/suicides were a cause for concern, although risk factors (history of depression, suicide attempts, etc.) were described for 66% of patients experiencing these events. Patients reporting angioedema and serum sickness-like reactions, and those involved in suicide attempts/suicides, were significantly younger than the exposed population. A dose-dependent effect was also apparent for angioedema and for seizures. Cardiovascular SARs, such as ischaemic heart disease (10.1%) or sudden death (2.3%), were very often associated with pre-existing coronary artery disease induced by smoking. All these SARs occurred within a median of 12-14 days after drug initiation.

Conclusion: To ensure safer use of bupropion, health professionals must respect the strict contraindications and warnings about use of this drug in patients with a history of seizures. Seizures, angioedema and serum sickness-like reactions were the most frequently reported SARs to bupropion treatment in our study. Moreover, younger people appeared to be more at risk for cutaneous SARs generally, and younger women for angioedema in particular, perhaps because of weight-related differences in pharmacokinetics. A dose-dependent effect for angioedema and the results of skin tests were suggestive of a histamine liberation mechanism. Our analysis showed that taking more notice of the contraindications to use of bupropion could have prevented half the seizures reported to the database. The sex and age characteristics of patients with ischaemic heart disease and suicide attempts in the study population were similar to those of the French population as a whole. Whether bupropion is associated with an increase in these potential adverse effects of therapy can be determined only by epidemiological studies that take into account specific risk factors in the smoking population. Finally, the median time to onset of the SARs identified in this study suggests that prescribers should monitor patients exposed to bupropion more carefully during the first 2 weeks of treatment.
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http://dx.doi.org/10.2165/00002018-200831110-00006DOI Listing
January 2009

[Severe renal adverse events with arylcarboxylic non-steroidal anti-inflammatory drugs: results of a eight-year French national survey].

Therapie 2006 May-Jun;61(3):255-66

Centre Régional de Pharmacovigilance, Hôpital Bellevue, Saint-Etienne, France.

The non-steroidal anti-inflammatory drugs (NSAID) especially the arylcarboxylic, are widely prescribed for their different properties. The renal adverse events are rare but often serious. We have reviewed the French experience for the following eight years period: January 1995 to December 2002. Three hundred and nine cases have been reported to the French Pharmacovigilance system during that period including 275 adults, 29 children and 5 new-born babies. In 247 cases (80%), the presentation was an acute renal failure occurring few days after treatment onset but not always of the prerenal type. Overall 34 patients needed one or more dialysis session; the majority recovered either completely or partially, but nevertheless, we had to deplore 5 deaths. These major renal complications were observed with all available NSAID on the French market, including ibuprofen which was often prescribe as pain-reliever. With this data together with international information, the French Drug Agency decided to modify the summary of products characteristics of these NSAID.
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November 2006