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Trenque T.,Reims University Hospital Center | Trenque T.,University of Reims Champagne Ardenne | Herlem E.,Reims University Hospital Center | Auriche P.,Afssaps | And 2 more authors.
Drug Safety | Year: 2011

Background: Hyperprolactinaemia is a common endocrinological disorder that can be caused by a variety of physiological and pathological conditions, although in a large proportion of cases hyperprolactinaemia is drug-induced. Serotonin reuptake inhibitors (SRIs) are reportedly associated with hyperprolactinaemia; however, the number of published cases in the literature is limited. Objective: The aim of the study was to investigate the association between exposure to SRIs and the risk of reporting of hyperprolactinaemia in a spontaneous reporting database. Methods: All cases of adverse drug reactions (ADRs) involving hyperprolactinaemia spontaneously reported to the French Pharmacovigilance Database from 1985 to December 2009 were reviewed. Cases of hyperprolactinaemia in SRI users were described. In a case/non-case analysis, the association between reported cases of hyperprolactinaemia and the use of SRIs was assessed by calculating reporting odds ratios (ROR) with their 95% confidence intervals (CIs). Results: A total of 11 863 reports with SRIs were collected, of which 187 reported hyperprolactinaemia ADRs. Subjects were 39.7-13.5 years of age on average and mainly female (71%). We observed an increased risk of reporting of hyperprolactinaemia with the use of SRIs as antidepressants (overall ROR 3.3; 95% CI 2.8, 3.8), particularly with fluvoxamine (ROR 4.5; 95%CI 2.8, 7.2), citalopram (ROR 3.9; 95%CI 2.6, 5.8), fluoxetine (ROR 3.6; 95% CI 2.8, 4.7) and paroxetine (ROR 3.1; 95% CI 2.3, 4.2). Duloxetine, milnacipran and sertraline were not associated with an increased risk of reporting of hyperprolactinaemia. Conclusions: Treatment with SRIs is associated with an increased risk of reported hyperprolactinaemia. When investigating the aetiology of diagnosed hyperprolactinaemia, physicians should systematically enquire about treatment with SRIs. The risk of hyperprolactinaemia should be mentioned in the labelling of all SRI compounds. © 2011 Layton et al., publisher and licensee Adis Data Information BV.


Lawton J.,Henri Mondor University Hospital | Touma J.,Henri Mondor University Hospital | Senemaud J.,Henri Mondor University Hospital | de Boissieu P.,Reims University Hospitals | And 3 more authors.
Surgical and Radiologic Anatomy | Year: 2016

Purpose: Endovascular navigation in aortic, renal and visceral procedures are based on precise knowledge of arterial anatomy. Our aim was to define the anatomical localization of the ostia of renovisceral arteries and their distribution to establish anatomical landmarks for endovascular catheterization. Methods: Computer-assisted measurements performed on 55 CT scans and patients features (age, sex, aortic diameter) were analyzed. p values <0.05 were considered statistically significant. Results: The mean axial angulation of CeT and the SMA origin was 21.8° ± 10.1° and 9.9° ± 10.5°, respectively. The ostia were located on the left anterior edge of the aorta in 96 % of cases for the CeT and 73 % for the SMA. CeT and SMA angles followed Gaussian distribution. Left renal artery (LRA) rose at 96° ± 15° and in 67 % of cases on the left posterior edge. The right renal artery (RRA) rose at −62° ± 16.5° and in 98 % of cases on the right anterior edge of the aorta. RRA angle measurements and cranio-caudal RRA-LRA distance measurements did not follow Gaussian distribution. The mean distances between the CeT and the SMA, LRA, and RRA were 16.7 ± 5.0, 30.7 ± 7.9 and 30.5 ± 7.7 mm, respectively. CeT-SMA distance showed correlation with age and aortic diameter (p = 0.03). CeT-LRA distance showed correlation with age (p = 0.04). The mean distance between the renal ostia was 3.75 ± 0.21 mm. The RRA ostium was higher than the LRA ostium in 52 % of cases. RRA and LRA origins were located at the same level in 7 % of cases. Conclusion: Our results illustrate aortic elongation with ageing and high anatomical variability of renal arteries. Our findings are complementary to anatomical features previously published and might contribute to enhance endovascular procedures safety and efficacy for vascular surgeons and interventional radiologists. © 2016 Springer-Verlag France


Trenque T.,Reims University Teaching Hospitals | Trenque T.,University of Reims Champagne Ardenne | Maura G.,Reims University Teaching Hospitals | Herlem E.,Reims University Teaching Hospitals | And 5 more authors.
Drug Safety | Year: 2013

Background: Depressive disorders and use of antidepressants are associated with adverse effects on sexual function. In pharmacoepidemiological studies, sexual disorders are reported by more than 50 % of patients taking serotonin reuptake inhibitors (SRIs). Objective: The aim of this study was to determine the reporting rate of sexual disorders in association with SRIs, and to investigate the association between reported cases and the use of SRIs. Methods: All cases of adverse drug reactions (ADRs) involving sexual disorders, spontaneously reported to the French Pharmacovigilance Database from 1 January 1985 to December 2009, were reviewed. Cases of sexual disorders in SRI users were described. We calculated the rate of reported sexual disorders as a percentage of the total ADRs reported for each drug. The association between reported cases and the use of SRIs was assessed using reporting odds ratios (ROR) with 95 % confidence intervals (CIs). Results: A total of 11,863 ADRs in association with SRIs were collected, of which 98 (0.83 %) were spontaneous reports of sexual disorders. Subjects were, on average, 45.0 ± 10.6 years of age and mainly male. Sexual disorders were associated with the use of SRI antidepressants (ROR 4.47; 95 % CI 3.61-5.53), milnacipran (ROR 11.72; 95 % CI 5.79-23.72), fluvoxamine (ROR 6.91; 95 % CI 3.79-12.58), paroxetine (ROR 5.54; 95 % CI 3.92-7.83), venlafaxine (ROR 3.50; 95 % CI 1.93-6.36), fluoxetine (ROR 3.46; 95 % CI 2.26-5.29), citalopram (ROR 2.69; 95 % CI 1.28-5.67) and sertraline (ROR 2.49; 95 % CI 1.03-6.01). Conclusion: It is likely that there are instances of underreporting, particularly for ADRs that are embarrassing to talk about spontaneously. Despite the likely underreporting of this well-described adverse effect, this case/non-case study performed in a large national pharmacovigilance database confirms the existence of the risk of sexual disorders associated with SRIs, and is an example of the lack of sensitivity of spontaneous notification to measure ADRs. Minimization of antidepressant- induced sexual dysfunction could be an important factor to avoid unsuccessful treatment. Physicians should advise their patients on the possible sexual adverse effects. © 2013 Springer International Publishing Switzerland.


Salmon J.H.,Reims University Hospitals | Salmon J.H.,University of Reims Champagne Ardenne | Geoffroy M.,Reims University Hospitals | Eschard J.P.,Reims University Hospitals | Ohl X.,Reims University Hospitals
Vaccine | Year: 2015

Revaxis® is a vaccine against diphtheria, tetanus and poliomyelitis (dT-IPV). This vaccine should not be administered by the intradermal or intravenous route. Poor injection techniques and related consequences are rare.We report a case of bursitis associated with reactive glenohumeral effusion complicated by bone erosion occurring after injection of the dT-IPV vaccine. A 26 year old patient was admitted for painful left shoulder causing functional impairment. Control magnetic resonance imaging showed bone oedema on the upper outer part of the humeral head, with a slight cortical irregularity, indicating that the vaccine was injected in contact with the bone at this location, causing erosion. Outcome was favourable after intra-articular corticosteroids.Reports of articular or periarticular injury after vaccination are extremely rare, in view of the substantial number of vaccines administered every year. The potential complications of vaccination are well known to general practitioners but under-reported in the literature. © 2015 Elsevier Ltd.


Taam M.A.,Reims University Hospitals | De Boissieu P.,Reims University Hospitals | Taam R.A.,Pulmonology and Allergy Service | Breton A.,Reims University Hospitals | Trenque T.,Reims University Hospitals
European Journal of Psychiatry | Year: 2015

Background and Objectives: Hallucinations are sensory perceptions which occur without external stimuli. There are associated with psychiatric disease but also can be related to organic disease and drug or toxic exposure. The purpose of our study was to investigate the association between exposure to medications and the reporting of hallucinations using data from the spontaneous-reporting French Pharmacovigilance Database (FPVD). Methods: We used the case/noncase method in the FPVD. Cases were all the observations of hallucination with the LLT term “perception disturbances”, registered into the FPVD from January 1985 to Jan 2013. Data were expressed as odds ratio (OR) with their 95% confidence intervals. Results: Among the 469,181 reports of adverse effects recorded between 1985 and 2013, 4,086 are hallucinations. For about 50% of these hallucinations were experimented by patient older than 65 years old. A statistically significant OR was found with several medications included rasagiline (OR 17.6 [95%CI 10.4-29.8]), zolpidem (OR 12.9 [95%CI 11.3-14.8]), methylphenidate (OR 9.3 [95%CI 5.9-14.6]) and baclofene (OR 5.4 [95%CI 3.7-7.8]). An increased risk of hallucinations was also observed with non central nervous system drugs, including ertapenem (OR 24.0 [95%CI 14.2-40.5]), voriconazole (OR 12.9[95%CI 10.2-16.5]) and valacyclovir (OR 9.1 [95%CI 6.9-11. 9]). Conclusions: This pharmacoepidemiological study describes an association between drugs and hallucinations. This relationship involves not only some already suspected drugs but also other drugs less known to induce such an adverse reaction. Despite the mandatory limits of this kind of study, these data should lead to special precautions in patient at risk. © 2015 University of Zaragoza. All rights reserved.

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