Publications by authors named "Claire Guy"

36 Publications

Impact of the COVID-19 pandemic on gastrointestinal endoscopy in Africa.

Endosc Int Open 2020 Aug 7;8(8):E1097-E1101. Epub 2020 Aug 7.

Endoscopy Unit, Nuovo Regina Margherita Hospital, Rome, Italy.

As with all other fields of medical practice, gastrointestinal endoscopy has been impacted by the COVID-19 pandemic. However, data on the impact of the pandemic in Africa, especially sub-Saharan Africa are lacking. A web-based survey was conducted by the International Working Group of the European Society for Gastrointestinal Endoscopy and the World Endoscopy Organization to determine the impact and effects the COVID-19 pandemic has had on endoscopists in African countries. Thirty-one gastroenterologists from 14 countries in north, central, and sub-Saharan Africa responded to the survey. The majority of respondents reduced their endoscopy volume considerably. Personal protective equipment including FFP-2 masks were available in almost all participating centers. Pre-endoscopy screening was performed as well. The COVID-19 pandemic has had a substantial impact on gastrointestinal endoscopy in most African countries; however, the impact may not have been as devastating as expected.
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http://dx.doi.org/10.1055/a-1210-4274DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413826PMC
August 2020

Partnership with African Countries: European Society of Gastrointestinal Endoscopy (ESGE) - Position Statement.

Endosc Int Open 2018 Oct 8;6(10):E1247-E1255. Epub 2018 Oct 8.

Gastroenterology and Endoscopy, Edouard Herriot Hospital, Lyon, France.

A new objective for the European Society of Gastrointestinal Endoscopy (ESGE) is to develop long-term partnerships with African countries. For this, an International Affairs Working Group (IAWG) was formed. In conjunction with the World Endoscopy Organization (WEO), ESGE conducted a survey of gastrointestinal (GI) endoscopy in Africa. Survey results showed that many African countries have few GI endoscopy centers with adequate resources. Barriers to the development of endoscopy services include a shortage of endoscopists who have undergone advanced endoscopy training, and a lack of equipment and basic infrastructure. Diseases related to infectious etiology are more prevalent than neoplastic diseases in Africa. Any development of endoscopy services needs to consider the local prevalence of diseases for which GI endoscopy is required, as well as the availability of resources. The IAWG will initiate a cascade approach to identify and adapt ESGE guidelines for local use. The guidelines will consider the level of resources available for each intervention, as well as cost, infrastructure, and training, and will be approved by consensus of local experts who are representative of different African areas. Suitable centers in African countries will be identified, and in future will be developed into WEO/ESGE training centers, to provide local training in both basic and advanced endoscopy according to the needs of the area.
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http://dx.doi.org/10.1055/a-0677-2026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6175688PMC
October 2018

Nicorandil-induced ulcerations: a 10-year observational study of all cases spontaneously reported to the French pharmacovigilance network.

Int Wound J 2018 Aug 16;15(4):508-518. Epub 2018 May 16.

Regional Center of Pharmacovigilance, University Hospital, Nancy, France.

Nicorandil-induced ulcers remain often poorly recognised, with a late diagnosis and an inadequate management. We aimed to provide a clinical overview of the 148 spontaneously reported cases of nicorandil-induced ulcers to the French pharmacovigilance network between 2005 and 2014 and to complete this picture with worldwide published cases over the same period. Spontaneously reported nicorandil-induced ulcers were mainly mucosal (oral and anal) with a previous trauma in 23·0% of patients, revealed by a severe complication in 12·8% of cases. The mean cumulative dose of nicorandil was higher in serious cases. The median delay between the start of nicorandil use and the onset of the ulcer was 23·4 months, and after the ulcer was diagnosed, the median time to incriminate nicorandil was still 3·3 months, being shorter for mucosal ulcerations than for cutaneous ulcerations (5·2 versus 14·0 months, P = 0·001). The anatomic distribution in the 199 published cases differed slightly, but delays were similar. The hypothesis of mechanism becomes more precise, leaving no doubt about the necessity to discontinue the treatment. Practitioners need to be aware that nicorandil-induced ulcers can occur in many locations, possibly multiple and complicated, and should be simply managed by discontinuing treatment with no further reintroduction of nicorandil.
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http://dx.doi.org/10.1111/iwj.12845DOI Listing
August 2018

Is acetaminophen associated with a risk of Stevens-Johnson syndrome and toxic epidermal necrolysis? Analysis of the French Pharmacovigilance Database.

Br J Clin Pharmacol 2018 02 10;84(2):331-338. Epub 2017 Nov 10.

Centre Régional de Pharmacovigilance, CHU - Centre de Biologie, EA 4681 PEPRADE, Université d'Auvergne, 58 Rue Montalembert -BP 69, 63003 Cedex 1, Clermont-Ferrand, France.

Aim: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare but severe mostly drug-induced cutaneous reactions. Acetaminophen is an over-the-counter drug used worldwide to treat pain and reduce fever. In 2013, the US Food and Drug Administration informed the public that acetaminophen was associated with a rare risk of SJS/TEN. The aim of the present retrospective study was to analyse reports of acetaminophen as a possible suspect in the development of SJS/TEN from the French Pharmacovigilance Database (FPDB).

Methods: Cases of TEN/SJS with acetaminophen as a suspect drug registered in the FPDB, collected from January 2002 to December 2013, were analysed by an expert group. The algorithm of drug causality for epidermal necrolysis (ALDEN) was used as a reference tool for SJS/TEN to assess the causality of each suspect drug.

Results: After exclusion of 16 nonvalidated cases, 112 cases (47 TEN, 51 SJS, 14 SJS/TEN overlaps) involving 574 suspected drugs (5⋅1/case) were analysed. In 80 cases, the acetaminophen ALDEN score was inferior or equal to that of other drugs, associated with a higher suspicion for causality. In 32 cases, acetaminophen had the highest score but matched with a 'very unlikely' or 'unlikely' causality in 12 cases. For the 20 remaining cases with a 'possible' or ' probable' causality, a protopathic or a confounding bias was likely in 14 cases.

Conclusions: After analysis of the French pharmacovigilance data using the ALDEN algorithm, we found no obvious SJS/TEN risk related to the use of acetaminophen in this large national series.
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http://dx.doi.org/10.1111/bcp.13445DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5777438PMC
February 2018

[Red yeast-rice-induced muscular injuries: Analysis of French pharmacovigilance database and literature review].

Therapie 2016 Oct 27. Epub 2016 Oct 27.

Département de pharmacologie médicale et toxicologie, centre régional de pharmacovigilance et d'information sur le médicament, hôpital Lapeyronie, CHU Lapeyronie, 371, avenue du Doyen-Gaston-Giraud, 34295 Montpellier cedex 5, France.

Red yeast rice (RYR) is a dietary supplement containing monacolins obtained by fermentation of Monascus purpureus strains. Because of its structural homology with lovastatin, monacolin K inhibits HMG-CoA reductase and shows hypocholesterolemic properties comparable to synthetic statins. We studied all cases of myopathy involving RYR reported in the French national pharmacovigilance database (6 cases) and in scientific literature (9 cases). Among these cases, 9 showed elevated creatine kinase, 3 rhabdomyolysis and 2 myalgia. Recent studies seem to show good efficacy of the RYR, however, our work reports the existence of related muscular disorders. In addition, dietary supplements currently available on the market may show considerable variability of formulation and/or the presence of contaminants. When clinicobiological disorders occur, physicians should consider the eventual use of an herbal treatment.
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http://dx.doi.org/10.2515/therapie/2015053DOI Listing
October 2016

ESGE Survey: worldwide practice patterns amongst gastroenterologists regarding the endoscopic management of Barrett's esophagus.

Endosc Int Open 2016 Jan;4(1):E36-41

South Tyneside District Hospital, South Shields, UK; Northern Region Endoscopy Group, UK; School of Medicine, Pharmacy and Health, University of Durham, Stockton on Tees, UK.

Background And Study Aims: Barrett's esophagus is a common condition that is widely encountered in clinical practice. This European Society of Gastrointestinal Endoscopy (ESGE) survey aimed to determine practice patterns amongst European clinicians with regard to the diagnosis and management of Barrett's esophagus.

Methods: Clinicians attending the ESGE learning area at the United European Gastroenterology Week in 2014 were invited to complete a 10-question survey. This survey was programed on to two Apple iPads. Information was gathered with regard to demographics, practice settings, and diagnosis and management strategies for Barrett's esophagus.

Results: In total, 163 responses were obtained. Over half of respondents (61 %) were based in university hospitals, the majority (78 %) were aged 30 - 50 and half had more than 10 years' experience; 66 % had attended courses on Barrett's esophagus and more than half (60 %) used the Prague C & M classification. Advanced imaging was used by 73 % of clinicians and 72 % of respondents stated that their group practiced ablation therapy. Most (76 %) practiced surveillance for non-dysplastic Barrett's, 6 % offered ablation therapy in some situations, and 18 % offered no intervention. For low grade dysplasia, 56 % practiced surveillance, 19 % ablated some cases and 15 % ablated all cases. In total, 32 % of clinicians referred high grade dysplasia to expert centers, with 20 % referring directly for surgery and 46 % using ablation therapy in certain cases. Endoscopic mucosal resection was the most commonly used ablation technique (44 %).

Conclusions: There has been reasonable uptake of the Prague C & M classification for describing Barrett's esophagus, and ablation is widely practiced. However, practice patterns for Barrett's esophagus vary widely between clinicians with clear guidance and quality standards required.
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http://dx.doi.org/10.1055/s-0034-1393247DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4713172PMC
January 2016

Validation and Reproducibility of the Updated French Causality Assessment Method: an Evaluation by Pharmacovigilance Centres & Pharmaceutical Companies.

Therapie 2015 Sep-Oct;70(5):465-76. Epub 2015 Jun 26.

Cellule Plan de Gestion de Risque, ANSM, Saint-Denis, France.

Objective: Assess the validity and reproducibility of the updated version of the French causality assessment method in conditions approaching real-life use.

Methods: A random sample of 31 drug-event pairs from the French pharmacovigilance database was assessed by the consensual judgement of three experts (gold standard). Separately, a team from a pharmacovigilance centre (PhVC) and another from a pharmaceutical company assessed these pairs using the current method, then with the updated method. To test the inter- and intra-rater reproducibility, two seniors and two juniors from a PhVC and a pharmaceutical company assessed the pairs twice with the updated method. A weighted kappa coefficient was used to measure the agreement of the two causality assessment methods with the consensual expert judgement (validity) as well as the agreement of the updated causality assessment over time (intra-rater reproducibility) and between evaluators (inter-rater reproducibility).

Results: Agreement between the current method and consensual expert judgement was fair for the PhVC team (weighted kappa [Kw] 0.33) and moderate for the pharmaceutical company team (Kw 0.41). For the updated method, agreement was better for both the PhVC (Kw 0.58) and the pharmaceutical company (Kw 0.52) teams. The inter- and intra-rater reproducibility of the updated method based on the intrinsic imputability was satisfactory overall (Kw 0.30-0.91). Discrepancies between evaluations from PhVC and pharmaceutical companies were observed with the updated method.

Conclusion: The updated method performed better than the current one for drug causality assessment, suggesting that it should be used in routine pharmacovigilance.
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http://dx.doi.org/10.2515/therapie/2015028DOI Listing
December 2015

[Drug Shortage May Have Serious Outcome: the French Exemple of Phenytoine].

Therapie 2015 Jul-Aug;70(4):377-80. Epub 2015 Apr 16.

Centre Régional de Pharmacovigilance, CHRU, Lille, France.

In 2012, in France, phenytoin sodium was used as a substitute for phenytoin base during a shortage at the dose of 100 mg for 100 mg, according to the French Health Agency recommendations. However, this substitution was problematic because the two specialties were not bioequivalent. We report here the case of a 29-year old woman who presented with severe epilepsy. The substitution of phenytoin base by phenytoin sodium induced an increase of seizure frequency leading to several hospitalizations and sick leave. Phenytoin base was finally available again in 2013 which allowed a reduction of seizure frequency. Six similar cases, including one death, were reported to the French pharmacovigilance system. Drug shortages are increasingly common and can have serious consequences. Reporting the difficulties that drug shortage causes to health authorities is important in order to improve their management and to better support patients.
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http://dx.doi.org/10.2515/therapie/2015018DOI Listing
August 2015

[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

Are adverse drug reaction patterns different between romiplostim and eltrombopag? 2009-2013 French PharmacoVigilance assessment.

Eur J Intern Med 2014 Oct 18;25(8):777-80. Epub 2014 Sep 18.

Laboratoire de Pharmacologie Médicale et Clinique, Université Paul Sabatier, Faculté de Médecine, 37 Allées Jules-Guesde, 31000 Toulouse, France; Equipe de Pharmacoépidémiologie de l'INSERM U 1027, Faculté de Médecine, 37 Allées Jules-Guesde, 31000 Toulouse, France; Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Centre Hospitalier Universitaire de Toulouse, Faculté de Médecine, 37 Allées Jules-Guesde, 31000 Toulouse, France.

Background: Romiplostim and eltrombopag, the two marketed thrombopoietin receptor agonists (TPO-RAs), have distinct binding sites and might have distinct pharmacodynamic mechanisms. The aim of this study was to compare their adverse drug reaction (ADR) patterns.

Methods: We selected in the French PharmacoVigilance Database all ADRs associated with TPO-RAs from TPO-RA marketing until the 31st of December 2013. Medical charts were reviewed. We conducted disproportionality analyses comparing romiplostim exposure in the reports of a given ADR pattern (thrombosis, neurological, cutaneous, gastrointestinal or hematological) to romiplostim exposure in all other TPO-RA-related ADR reports. Reporting Odds Ratios (RORs) were adjusted for age and gender. We also compared the number of reports of a given ADR pattern per million daily defined doses (DDDs) dispensed in France during the study period.

Results: We described 45 reports (53 ADRs) with romiplostim and 26 reports (37 ADRs) with eltrombopag. There were 19 venous thromboses. At least one other risk factor was present in 83.3% of the cases. Ten (55.6%) patients had been splenectomized previously. There were eight arterial thromboses. Another risk factor was noticed in all cases. There was no signal for an excess risk of thrombosis with romiplostim versus eltrombopag (ROR: 1.45, 95% CI [0.48-4.45]). There was a signal for a higher risk of gastrointestinal ADRs with eltrombopag (ROR: 30.28, 95% CI [3.23-383.86]) and of hematological ADRs with romiplostim (ROR: 14.36, 95% CI [1.73-119.08]). Dispensing data-adjusted comparisons led to similar results.

Conclusions: This study suggests different ADR patterns between romiplostim and eltrombopag.
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http://dx.doi.org/10.1016/j.ejim.2014.09.006DOI Listing
October 2014

Corneal perforation: another side effect of nicorandil.

Cutan Ocul Toxicol 2014 Jun 11;33(2):96-8. Epub 2013 Jul 11.

Department of Ophthalmology .

Context: Nicorandil is an antianginal drug used for 20 years in Japan and introduced in France in 1994. Since 1997, side effects such as mucocutaneous ulcerations have regularly been reported.

Objective: To describe the first case of a patient with a spontaneous corneal perforation associated with mucocutaneous ulcerations while taking Nicorandil.

Materials And Methods: A 81-year-old patient, with no past history of ocular disease but a long past history of cardiovascular disease, presented with a spontaneous paracentral corneal perforation. This was consecutive to 5 months of recurrent keratoconjunctivitis and mucocutaneous ulcerations resistant to conventional therapy. (He was taking nicorandil for 5 years.) A penetrating keratoplasty was performed in emergency.

Results: Inflammatory and infectious causes of spontaneous corneal perforation were ruled out. After initial uneventful post-operative wound healing, an epithelial ulcer appeared on the graft. Dermatologists suggested the iatrogenic role of nicorandil and the drug was discontinued. Both mucocutaneous and corneal ulcerations resolved rapidly.

Discussion: Although mucocutaneous ulcerations have been attributed several times to nicorandil, this is, to our knowledge, the first major corneal damage due to this antianginal drug. Timing, pattern of illness, absence of other aetiology, recurrence of epithelial ulceration on the corneal graft and its spontaneous healing after nicorandil discontinuation make it highly apparent probable that nicorandil was directly involved in this corneal perforation.

Conclusion: Ophthalmologists and dermatologists should be aware of the risk of severe but reversible corneal ulcerations in patients treated with nicorandil. A pharmacovigilance warning statement should be compulsory.
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http://dx.doi.org/10.3109/15569527.2013.812105DOI Listing
June 2014

Adverse drug reactions in patients with Alzheimer's disease and related dementia in France: a national multicentre cross-sectional study.

Pharmacoepidemiol Drug Saf 2013 Sep 24;22(9):952-60. Epub 2013 Jun 24.

Regional Centre of Pharmacovigilance, Pharmacology-Toxicology-Pharmacovigilance Unit, University Hospital, Limoges, 87042, France.

Purpose: To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer's disease (AD) or other dementia in France.

Methods: A cross-sectional multicentre study was conducted by the French network of the 31 regional pharmacovigilance centres on a given day. The subjects were selected by random draw to be a representative sample of French patients with dementia: consultations of dementia clinics, nursing-homes, acute and long care geriatric units, rehabilitation care geriatric units. The staff of each medical structure together with that of the pharmacovigilance centre defined a day for including the patients. Socio-demographic data, history, ADR and drugs given were registered.

Results: There were 1332 subjects included, 51.1% living at home, 48.8% in institutions, aged 82.0 ± 8.0 years (46-108); 61.3% suffered from AD. Mean number of drugs was 6.3 ± 3.1. Anti-dementia drugs were given to 66.4% subjects. ADR prevalence was 5.0% (95% CI: 3.9-6.2) without a significant difference between at home and institutionalized patients. ADR consisted of gastro-intestinal (23.2%), central nervous system (17.4%) and psychiatric disorders (8.7%). Of the ADR, 31.9% were serious, and 47.8% preventable. The drugs most often involved were anti-dementia (28.9%), cardio-vascular (28.9%) and psychotropic drugs (26.4%, anxiolytics, hypnotics, antidepressants, neuroleptics).

Conclusion: This national scale study showed that iatrogenesis in patients with AD and related dementia can at times be serious and preventable. Therefore, special attention is required when prescribing psychotropic and anti-dementia drugs, as they are frequently used and induce half of the ADR in this population.
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http://dx.doi.org/10.1002/pds.3471DOI Listing
September 2013

Updating the French method for the causality assessment of adverse drug reactions.

Therapie 2013 Mar-Apr;68(2):69-76. Epub 2013 Jun 18.

Cellule Plan de Gestion de risque, ANSM, Saint-Denis, France.

The Imputability Working Group (CRI) updated the French drug reaction causality assessment method. This tripartite group is made up of staff from the French network of regional pharmacovigilance centres, pharmaceutical companies, and the French National Agency for the Safety of Medicines and Health Products (ANSM). After reviewing the strengths and weaknesses of the previous method, several ideas for improvement were proposed: a better-worded and more discriminating scale for certain chronological and semiological criteria, a larger scale for the intrinsic score (increased from 5 to 7 levels), a new bibliographical scale to differentiate between expected and unexpected adverse drug reactions, and a new informativeness scale.
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http://dx.doi.org/10.2515/therapie/2013016DOI Listing
August 2013

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

Nicorandil: from ulcer to fistula into adjacent organs.

Int Wound J 2013 Apr 28;10(2):210-3. Epub 2012 Mar 28.

Department of Clinical Pharmacology, University Hospital of Nancy, Nancy, France.

Nicorandil is an original vasodilatator used to control angina by decreasing cardiac preload and afterload. Since 1997, many reports of single or multiple nicorandil-induced ulcerations have been published. To date, eight cases of nicorandil-induced fistula into adjacent organs have been described. The pathogeneses of nicorandil-induced ulceration and fistula into adjacent organs are not yet elucidated. The two main hepatic biotransformation pathways of nicorandil are denitration and reduction of the alkyl chain leading to nicotinamide and niconitic acid which merge into the endogenous pool of nicotinamide adenine dinucleotide/phosphate. This merging which is known as saturable, may contribute to a slow and abnormal distribution of nicotinamide and nicotinic acid out of the endogenous pool. Under these special conditions, providing these two molecules in situ, nicotinic acid associated with nicotinamide may ulcerate rather recent or maintained trauma. Ulcers and fistulae induced by nicorandil heal after withdrawal. Surgical intervention is unnecessary and inappropriate as it is ineffective and exacerbates morbidity. All practitioners should be correctly informed about these serious but preventable nicorandil side effects, which mostly occur in the elderly and fragile population. In the absence of corrective measures, withdrawal of this original and active drug should be considered.
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http://dx.doi.org/10.1111/j.1742-481X.2012.00966.xDOI Listing
April 2013

[Update of the French drug reaction assessment method].

Therapie 2011 Nov-Dec;66(6):517-25. Epub 2011 Dec 21.

Cellule Plan de Gestion de Risque, Afssaps, Saint-Denis, France.

A tripartite group, entitled « CRI » (for Cercle de réflexion sur l'imputabilité), involving French pharmacovigilance staff from the French network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and from French Health Authorities (Agence française de sécurité sanitaire des produits de santé) has worked to update the French drug reaction assessment method. Following assessment of strengths and weaknesses of the previous method, several points for improvement are proposed: a more precise wording and a more discriminating scale for some of the chronological and semiological criteria, a wider distribution of the intrinsic score from 5 to 7 levels, a new bibliographic scale for differentiating expected and unexpected adverse drug reactions, and a new informativness scale. This updated method would lead to a more relevant assessment of relationship between a drug and the occurrence of an adverse reaction. Furthermore, this method is a teaching tool to assess the level of relationship between a drug and the occurrence of an adverse reaction.
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http://dx.doi.org/10.2515/therapie/2011073DOI Listing
December 2012

[Not Available].

Therapie 2011 Nov-Dec;66(6):517-25

Centre Régional de Pharmacovigilance et de Renseignement sur le Médicament, CHU Besançon, France. Electronic address:

A tripartite group, entitled « CRI » (for Cercle de réflexion sur l'imputabilité), involving French pharmacovigilance staff from the French network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and from French Health Authorities (Agence française de sécurité sanitaire des produits de santé) has worked to update the French drug reaction assessment method. Following assessment of strengths and weaknesses of the previous method, several points for improvement are proposed : a more precise wording and a more discriminating scale for some of the chronological and semiological criteria, a wider distribution of the intrinsic score from 5 to 7 levels, a new bibliographic scale for differentiating expected and unexpected adverse drug reactions, and a new informativness scale. This updated method would lead to a more relevant assessment of relationship between a drug and the occurrence of an adverse reaction. Furthermore, this method is a teaching tool to assess the level of relationship between a drug and the occurrence of an adverse reaction.
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http://dx.doi.org/10.2515/therapie/2011073DOI Listing
July 2016

[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

Can the spread of non-native oysters (Crassostrea gigas) at the early stages of population expansion be managed?

Mar Pollut Bull 2010 Jul 1;60(7):1059-64. Epub 2010 Mar 1.

School of Biological Sciences, Queen's University Belfast, BT9 7BL, UK.

The Pacific oyster (Crassostrea gigas) was introduced into Strangford Lough, Northern Ireland in the 1970s. It was assumed that local environmental conditions would not facilitate successful reproduction. However, in the 1990s there were reports of C. gigas outside licensed aquaculture sites and this investigation set out to ascertain the current distribution, years of likely recruitment and population structure of the species. C. gigas were found distributed widely throughout the northern basin during surveys; the frequency distribution suggesting C. gigas is not recruiting every year. Establishment of feral populations of C. gigas elsewhere have linked to habitat change. A pilot cull was initiated to assess the success rate of early intervention. This paper demonstrates the potential benefits of responding rapidly to initial reports of non-native species in a way that may curtail establishment and expansion. The method advocated in simple and can be recommended to the appropriate regulatory authorities.
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http://dx.doi.org/10.1016/j.marpolbul.2010.01.020DOI Listing
July 2010

Trends of the potentially inappropriate medication consumption over 10 years in older adults in the East of France.

Pharmacoepidemiol Drug Saf 2009 Dec;18(12):1125-33

Centre technique d'appui et de formation des Centres d'examens de santé (CETAF), 67-69 Avenue de Rochetaillée, Saint-Etienne cedex 02.

Purpose: To describe the trends of potentially inappropriate medication (PIM) use in older adults from 1995 to 2004 in the East of France, by using the 1997 Beers criteria and its French update, and to assess risk factors for this PIM use.

Methods: We carried out a repeated cross-sectional study using data collected among people aged >/=65 years, examined in the Center for Preventive Medicine. Studied variables were socio-demographic, clinical data, medication consumption and the self-health status. Joinpoint regression analysis was used to estimate the temporal changes in PIM rate.

Results: 30 683 participants were included. 51.2% were women. The mean age was 70.1 +/- 4.3 years [65-99]. The annual overall rate of PIM use decreased significantly during the study period. These rates range from 14.9% in 1995 to 9.0% in 2004 according the Beers criteria (-3.4% per year) and from 33.5% in 1995 to 19.3% in 2004 according to the French update criteria (-3.6% per year). The annual rate of medication users increased during the same period (+0.75% per year). The risk of PIM consumption increased with age, number of drugs and frequency of the visits to the physician (OR = 1.26 [1.18-1.35]). This risk was also higher among women (OR = 1.29 [1.18-1.40]), elderly living alone (OR = 1.09 [1.02-1.17]) and with those with low education level (OR = 1.19 [1.02-1.38]).

Conclusion: This study shows a decrease in PIM consumption. Despite an increase of drug use in the elderly, an improving of the quality of this consumption remains possible.
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http://dx.doi.org/10.1002/pds.1762DOI Listing
December 2009

Brain activity changes associated with treadmill training after stroke.

Stroke 2009 Jul 21;40(7):2460-7. Epub 2009 May 21.

Department of Neurology, Medical University of Graz, Graz, Austria.

Background And Purpose: The mechanisms underlying motor recovery after stroke are not fully understood. Several studies used functional MRI longitudinally to relate brain activity changes with performance gains of the upper limb after therapy, but research into training-induced recovery of lower limb function has been relatively neglected thus far.

Methods: We investigated functional reorganization after 4 weeks of treadmill training with partial body weight support in 18 chronic patients (mean age, 59.9+/-13.5 years) with mild to moderate paresis (Motricity Index affected leg: 77.7+/-10.5; range, 9 to 99) and gait impairment (Functional Ambulation Category: 4.4+/-0.6; range, 3 to 5) due to a single subcortical ischemic stroke using repeated 3.0-T functional MRI and an ankle-dorsiflexion paradigm.

Results: Walking endurance improved after training (2-minute timed walking distance: 121.5+/-39.0 versus pre: 105.1+/-38.1 m; P=0.0001). For active movement of the paretic foot versus rest, greater walking endurance correlated with increased brain activity in the bilateral primary sensorimotor cortices, the cingulate motor areas, and the caudate nuclei bilaterally and in the thalamus of the affected hemisphere.

Conclusions: Despite the strong subcortical contributions to gait control, rehabilitation-associated walking improvements are associated with cortical activation changes. This is similar to findings in upper limb rehabilitation with some differences in the involved cortical areas. We observed bihemispheric activation increases with greater recovery both in cortical and subcortical regions with movement of the paretic foot. However, although the dorsal premotor cortex appears to play an important role in recovery of hand movements, evidence for the involvement of this region in lower extremity recovery was not found.
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http://dx.doi.org/10.1161/STROKEAHA.109.550053DOI Listing
July 2009

Seizure during Graves' disease.

Epileptic Disord 2009 Jun 9;11(2):136-7. Epub 2009 Mar 9.

Endocrinology Department, Hôpital Bellevue, CHU Saint-Etienne, France.

Occurrence of seizure during Graves' disease is very rare. According to Lin et al. (1992), only 13 cases were published between 1956 and 1992. Since then, four other cases have been published, resulting in a total of 17 papers in 40 years (Li et al. 2000, Lee et al. 1997, Radetti et al. 1993). We report, in this paper, the case of a young girl treated for recurrent Graves' disease who presented a generalized seizure.
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http://dx.doi.org/10.1684/epd.2009.0242DOI Listing
June 2009

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

Functional MRI correlates of lower limb function in stroke victims with gait impairment.

Stroke 2008 May 13;39(5):1507-13. Epub 2008 Mar 13.

Department of Neurology, Medical University of Graz, Auenbruggerplatz 22, A-8036 Graz, Austria.

Background And Purpose: Although knowledge concerning cortical reorganization related to upper limb function after ischemic stroke is growing, similar data for lower limb movements are limited. Previous studies with hand movement suggested increasing recruitment of motor areas in the unlesioned hemisphere with increasing disability. We used ankle movement as a lower limb analog to test for similarities and differences in recovery patterns.

Methods: Eighteen subjects were selected with chronic residual gait impairment due to a single subcortical ischemic stroke. Functional MRI scans were obtained at 3.0 T during active and passive ankle dorsiflexion in the patients (8 females, 10 males; mean age, 59.9+/-13.5 years; range, 32 to 74 years) and 18 age-matched healthy control subjects.

Results: We observed substantial neocortical activity associated with foot movement both in the patients with stroke and in the healthy control subjects. Our primary finding was increased cortical activation with increasing functional impairment. The extent of activation (particularly in the primary sensorimotor cortex and the supplementary motor area of the unlesioned hemisphere) increased with disability. The changes were most prominent with the active movement task.

Conclusions: Using ankle movement, we observed increased activation in the unlesioned hemisphere associated with worse function of the paretic leg, consistent with studies on movement of paretic upper limbs. We interpret this finding as potentially adaptive recruitment of undamaged ipsilateral motor control pathways from the supplementary motor area and (possibly maladaptive) disinhibition of the ipsilateral sensorimotor cortex.
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http://dx.doi.org/10.1161/STROKEAHA.107.501999DOI Listing
May 2008