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Article ; Online: Tixagevimab-Cilgavimab Treatment and Cardiovascular Events: Immortal Time Bias.

Montastruc, François / de Canecaude, Claire

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2023 Volume 76, Issue 11, Page(s) 2044–2045

MeSH term(s)	Humans ; Antibodies, Monoclonal ; Cardiovascular Diseases/epidemiology
Chemical Substances	tixagevimab ; cilgavimab (1KUR4BN70F) ; Antibodies, Monoclonal
Language	English
Publishing date	2023-02-16
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciad089
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Article ; Online: Drug-induced psychiatric disorders: A pharmacovigilance update.

Montastruc, François / Taillefer de Laportaliere, Tanguy

Therapie

2023 Volume 79, Issue 2, Page(s) 173–179

Abstract: The psychiatric risks associated with drugs are sometimes one of the few restrictions on the use of certain drug classes, such as corticosteroids in patients with a history of severe psychotic episodes associated with this drug class. In this non- ... ...

Abstract	The psychiatric risks associated with drugs are sometimes one of the few restrictions on the use of certain drug classes, such as corticosteroids in patients with a history of severe psychotic episodes associated with this drug class. In this non-exhaustive review, we propose to deal with the most recent issues concerning psychiatric disorders induced by drugs and encountered in doctors' clinical practice. Firstly, we look at depressive disorders and suicide risks, secondly at psychotic and manic disorders and thirdly at anxiety and sleep disorders. While lot of drugs are associated with psychiatric disorders, the confounding by indication represents an important methodological gap since information on the psychiatric profile of patients is not always available. This is particularly the case for serotonin reuptake inhibitors and esketamine used as antidepressants. Recent pharmacovigilance concerns of psychiatric disorders emerged with montelukast, orexin receptor antagonists or cystic fibrosis transmembrane regulator (CFTR) modulators.
MeSH term(s)	Humans ; Pharmacovigilance ; Mental Disorders/chemically induced ; Mental Disorders/drug therapy ; Mental Disorders/epidemiology ; Antidepressive Agents/adverse effects ; Selective Serotonin Reuptake Inhibitors
Chemical Substances	Antidepressive Agents ; Selective Serotonin Reuptake Inhibitors
Language	English
Publishing date	2023-10-31
Publishing country	France
Document type	Journal Article
ZDB-ID	603474-3
ISSN	1958-5578 ; 0040-5957
ISSN (online)	1958-5578
ISSN	0040-5957
DOI	10.1016/j.therap.2023.09.007
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Article ; Online: Tramadol and the risk of bleeding complications in patients on oral anticoagulants: a pharmacovigilance study.

Montastruc, Jean-Louis / Montastruc, François / Bura-Rivière, Alessandra

European journal of clinical pharmacology

2023 Volume 79, Issue 5, Page(s) 701–702

MeSH term(s)	Humans ; Tramadol/adverse effects ; Pharmacovigilance ; Anticoagulants/adverse effects ; Adverse Drug Reaction Reporting Systems ; Administration, Oral
Chemical Substances	Tramadol (39J1LGJ30J) ; Anticoagulants
Language	English
Publishing date	2023-03-28
Publishing country	Germany
Document type	Letter ; Comment
ZDB-ID	121960-1
ISSN	1432-1041 ; 0031-6970
ISSN (online)	1432-1041
ISSN	0031-6970
DOI	10.1007/s00228-023-03480-w
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Article ; Online: Lamotrigine and risk of arrhythmias: A global pharmacovigilance analysis.

Orts, Lisa / Flumian, Clara / Montastruc, François

Journal of the neurological sciences

2023 Volume 448, Page(s) 120644

MeSH term(s)	Humans ; Lamotrigine/adverse effects ; Pharmacovigilance ; Anticonvulsants/adverse effects ; Arrhythmias, Cardiac/chemically induced ; Arrhythmias, Cardiac/epidemiology ; Arrhythmias, Cardiac/drug therapy ; Triazines
Chemical Substances	Lamotrigine (U3H27498KS) ; Anticonvulsants ; Triazines
Language	English
Publishing date	2023-04-05
Publishing country	Netherlands
Document type	Letter
ZDB-ID	80160-4
ISSN	1878-5883 ; 0022-510X ; 0374-8642
ISSN (online)	1878-5883
ISSN	0022-510X ; 0374-8642
DOI	10.1016/j.jns.2023.120644
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Article ; Online: Withdrawal syndrome after antipsychotics discontinuation: an analysis of the WHO database of spontaneous reports (Vigibase) between 2000 and 2022.

Storck, Wilhelm / de Laportalière, Tanguy Taillefer / Yrondi, Antoine / Javelot, Hervé / Berna, Fabrice / Montastruc, François

Psychopharmacology

2024

Abstract: Rationale: Withdrawal syndrome (WDS) has been described after discontinuation of antipsychotics. WDS could be the consequence of an over-activation of the dopaminergic pathway. Antipsychotics with a higher affinity for dopamine D2 receptors could be ... ...

Abstract	Rationale: Withdrawal syndrome (WDS) has been described after discontinuation of antipsychotics. WDS could be the consequence of an over-activation of the dopaminergic pathway. Antipsychotics with a higher affinity for dopamine D2 receptors could be associated with a higher risk of WDS. This study aims to address this statement and evaluate the risk difference for withdrawal syndrome between antipsychotics based on pharmacovigilance data. Methods: We collected individual reports registered in Vigibase® between 01/01/2000 and 31/12/2022 of patients treated with antipsychotics and who had presented WDS. A disproportionality analysis was performed to evaluate the risk of reporting WDS with each antipsychotic compared to all other antipsychotics. We performed a correlation analysis to assess the correlation between the risk of reporting WDS for each antipsychotic in relation with their pKi for D2 and 5HT2A receptors. Results: The most frequent psychiatric withdrawal symptoms after antipsychotic discontinuation were insomnia, anxiety and depression. Tremor, headache and dizziness were among the most frequently reported neurologic withdrawal symptoms. Tiotixene had the highest risk of reporting WDS (ROR 7.08; 95%CI 3.49 - 14.35) followed by pimozide (ROR 4.35; 95%CI 1.93 - 9.77), quetiapine (ROR 4.24; 95%CI 3.87 - 4.64), thioridazine (ROR 4.17; 95%CI 2.50-6.98) and ziprasidone (ROR 2.98; 95%CI 2.41-3.67). We found a poor correlation between D2/5HT2A binding affinity and the risk of reporting withdrawal syndrome (R Conclusion: Our results suggest that there might be a risk difference for WDS between antipsychotics. Tiotixene, pimozide and quetiapine were associated with a higher risk of reporting a WDS whereas this risk was lower with chlorpromazine, clozapine and fluphenazine. We could not address the issue of withdrawal psychosis, withdrawal dyskinesia, rebound psychosis or supersensitivity psychosis due to the lack of specific WHO medDRA coded terms to identify potential cases.
Language	English
Publishing date	2024-02-20
Publishing country	Germany
Document type	Journal Article
ZDB-ID	130601-7
ISSN	1432-2072 ; 0033-3158
ISSN (online)	1432-2072
ISSN	0033-3158
DOI	10.1007/s00213-024-06554-4
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Article ; Online: Risk of abnormal uterine bleeding associated with high-affinity compared with low-affinity serotonin and norepinephrine reuptake inhibitors.

Engler, Julie / Filliter, Christopher / Montastruc, François / Abenhaim, Haim / Rej, Soham / Renoux, Christel

Journal of affective disorders

2024 Volume 350, Page(s) 813–821

Abstract: Background: Concerns have been raised about the potential association between selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs) and the risk of abnormal uterine bleeding (AUB), which may be influenced ... ...

Abstract	Background: Concerns have been raised about the potential association between selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs) and the risk of abnormal uterine bleeding (AUB), which may be influenced by the affinity of SSRIs/SNRIs for serotonin transporter. Thus, we assessed whether SSRIs/SNRIs with high-affinity for serotonin transporter are associated with AUB compared to SSRIs/SNRIs with low-affinity in non-pregnant women. Methods: Using the UK Clinical Practice Research Datalink, we identified a cohort of women aged 15-24 years, newly prescribed a high- or low-affinity SSRI/SNRI between 1990 and 2019. Confounding was addressed using standardized morbidity ratio weighting. We used weighted Cox proportional hazards models to estimate the hazard ratio (HR) and 95 % confidence interval (CI) of AUB associated with high-affinity compared with low-affinity SSRIs/SNRIs. We assessed the risk of anemia as a secondary outcome. Results: The cohort included 156,307 users of high-affinity SSRIs/SNRIs and 102,631 users of low-affinity SSRIs/SNRIs. High-affinity SSRIs/SNRIs were not associated with an increased risk of AUB compared with low-affinity SSRIs/SNRIs (incidence rates: 46.3 versus 42.4 per 1000 person-years, respectively; HR 1.01, 95 % CI 0.93-1.09). Duration of use, age, and comorbidities did not modify the risk. However, high-affinity SSRIs/SNRIs were associated with an increased risk of anemia (HR 1.29, 95 % CI 1.04-1.61) compared with low-affinity SSRIs/SNRIs. Limitations: Residual confounding may still be present. Conclusions: The risk of AUB did not differ between high- and low-affinity SSRIs/SNRIs. However, the potential risk of anemia suggests the need for monitoring and further investigation of the risk of AUB with these medications.
MeSH term(s)	Humans ; Female ; Selective Serotonin Reuptake Inhibitors/adverse effects ; Serotonin and Noradrenaline Reuptake Inhibitors/adverse effects ; Serotonin ; Serotonin Plasma Membrane Transport Proteins ; Uterine Hemorrhage ; Anemia ; Norepinephrine
Chemical Substances	Selective Serotonin Reuptake Inhibitors ; Serotonin and Noradrenaline Reuptake Inhibitors ; Serotonin (333DO1RDJY) ; Serotonin Plasma Membrane Transport Proteins ; Norepinephrine (X4W3ENH1CV)
Language	English
Publishing date	2024-01-19
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	135449-8
ISSN	1573-2517 ; 0165-0327
ISSN (online)	1573-2517
ISSN	0165-0327
DOI	10.1016/j.jad.2024.01.163
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Article ; Online: Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review.

Madi, Karima / Flumian, Clara / Olivier, Pascale / Sommet, Agnès / Montastruc, François

BMJ medicine

2023 Volume 2, Issue 1, Page(s) e000352

Abstract: Objective: To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of ... ...

Abstract	Objective: To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of serious adverse events in drug trials published on PubMed versus clinical trial summaries on ClinicalTrials.gov. Design: Systematic review. Data sources: PubMed and ClinicalTrials.gov registries were searched from 1 December 2019 to 17 February 2022. Eligibility criteria for selecting studies: Randomised clinical trials evaluating the efficacy and safety of drugs used to treat covid-19 disease in participants of all ages with suspected, probable, or confirmed SARS-CoV-2 infection were included. Clinical trials were screened on title, abstract, and text by two authors independently. Only articles published in French and English were selected. The Cochrane risk of bias tool for randomised trials (RoB 2) was used to assess risk of bias. Results: The search strategy identified 1962 randomised clinical trials assessing the efficacy and safety of drugs used to treat covid-19, published in the PubMed database; 1906 articles were excluded after screening and 56 clinical trials were included in the review. Among the 56 clinical trials, no study had a high score for quality of reporting of adverse events, 60.7% had a moderate score, 33.9% had a low score, and 5.4% had a very low score. All clinical trials with a very low score for quality of reporting of adverse events were randomised open label trials. For reporting of serious adverse events, journal articles published on PubMed under-reported 51% of serious adverse events compared with clinical trial summaries published on ClinicalTrials.gov. Conclusions: In one in three published clinical trials on covid-19 drugs, the quality of reporting of adverse events was low or very low. Differences were found in the number of serious adverse events reported in journal articles versus clinical trial summaries. During the covid-19 pandemic, risk assessment of drugs in clinical trials of covid-19 drugs did not comply with good practice recommendations for publication of results. Systematic review registration: European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) EUPAS45959.
Language	English
Publishing date	2023-09-21
Publishing country	England
Document type	Journal Article
ISSN	2754-0413
ISSN (online)	2754-0413
DOI	10.1136/bmjmed-2022-000352
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Article ; Online: Interest of pharmacoepidemiology for pharmacodynamics and analysis of the mechanism of action of drugs.

Lapeyre-Mestre, Maryse / Montastruc, François

Therapie

2019 Volume 74, Issue 2, Page(s) 209–214

Abstract: Pharmacology is often divided in separate branches, such as molecular and cellular pharmacology, pharmacokinetics, pharmacodynamics, experimental and/or preclinical pharmacology, clinical pharmacology (and therapeutics), pharmacogenetics, ... ...

Abstract	Pharmacology is often divided in separate branches, such as molecular and cellular pharmacology, pharmacokinetics, pharmacodynamics, experimental and/or preclinical pharmacology, clinical pharmacology (and therapeutics), pharmacogenetics, pharmacogenomics, pharmacovigilance, pharmacoepidemiology, pharmacoeconomics… This enumeration gives a global picture of different scientific areas, which are however dealing with the same question. Another mindset should be a global interactive and continuous approach, which could be designed as "human pharmacology". An original and attractive way to illustrate this continuous approach is to combine pharmacodynamics and pharmacovigilance and/or pharmacoepidemiologic data. Coupling disproportionality analyses in pharmacovigilance databases or computerized health databases, with pharmacological characteristics of drugs (receptor affinity, for example) allows investigating in humans, the mechanism of adverse drug reactions. Examples of such analyses investigating the risk of movement disorders, diabetes related to psychoactive drugs, or the risk of adverse cardiac outcomes with different drugs (classical drugs or protein kinase inhibitors) are given. The increasing number of research works investigating this topic underlines the importance of this relatively new approach, which gives significant inputs for the better knowledge of drug safety.
MeSH term(s)	Databases, Factual ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Humans ; Pharmacoepidemiology/methods ; Pharmacology, Clinical ; Pharmacovigilance ; Protein Kinase Inhibitors/administration & dosage ; Protein Kinase Inhibitors/adverse effects
Chemical Substances	Protein Kinase Inhibitors
Language	English
Publishing date	2019-02-06
Publishing country	France
Document type	Journal Article
ZDB-ID	603474-3
ISSN	1958-5578 ; 0040-5957
ISSN (online)	1958-5578
ISSN	0040-5957
DOI	10.1016/j.therap.2018.12.010
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Article ; Online: French pharmacovigilance survey of casirivimab - imdevimab monoclonal antibodies in coronavirus disease (COVID-19).

de Canecaude, Claire / Montastruc, François / Bergeron, Sandrine / Sanchez-Pena, Paola / Grandvuillemin, Aurélie

Therapie

2023 Volume 78, Issue 5, Page(s) 517–522

Abstract: Introduction: Casirivimab and imdevimab (Ronapreve®) are two recombinant human monoclonal antibodies (mAbs) that bind to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, preventing the virus from entering cells. In March ... ...

Abstract	Introduction: Casirivimab and imdevimab (Ronapreve®) are two recombinant human monoclonal antibodies (mAbs) that bind to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, preventing the virus from entering cells. In March 2021, this drug was granted emergency use authorisation (EUA) in France for early treatment of COVID-19 in patients at increased risk of progression to severe COVID-19. In August/September 2021, the indication was expanded to COVID-19 prevention (pre- or post-exposure prophylaxis) and treatment of hospitalised patients requiring non-invasive oxygen therapy. The aim of the study was to better describe the adverse drug reaction (ADR) profile and detect safety signals of this new drug used in COVID-19 treatment. Methods: We described ADR profile with casirivimab/imdevimab reported as suspect/interacting drug to the French pharmacovigilance network and the pharmaceutical company between 17/03/2021 and 30/06/2022. Data presented correspond to the 2 periods of the pharmacovigilance survey: the first carried out by the pharmaceutical company for curative and prophylactic uses and the second by Toulouse university regional pharmacovigilance center (RPVC). Results: A total of 384 reports were analysed and 256 were "serious". ADR profile was comparable between the 2 periods and between curative and prophylactic use, corresponding to expected ADRs such as infusion-related reactions and hypersensitivity, inefficiencies or worsened infections and deaths. Two potential pharmacovigilance signals were also studied: acute pulmonary oedemas and sudden deaths. Discussion: No pharmacovigilance signal emerged from this 15 months French pharmacovigilance survey. Moreover data from published studies are also reassuring. This pharmacovigilance survey was the first one for the new version of EUA and with a new ADR reporting process i.e. declaration to the RPVC instead of the pharmaceutical company. Casirivimab/imdevimab is no longer used in France today but we continue to monitor this drug for any future evidence of resurgent activity on a new variant of Sars-CoV-2.
Language	English
Publishing date	2023-02-22
Publishing country	France
Document type	Journal Article
ZDB-ID	603474-3
ISSN	1958-5578 ; 0040-5957
ISSN (online)	1958-5578
ISSN	0040-5957
DOI	10.1016/j.therap.2023.02.004
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Article ; Online: Parasitic Infections and Biological Therapies Targeting Type 2 Inflammation: A VigiBase Study.

Lifar, Philippine / Montastruc, François / Reber, Laurent L / Magnaval, Jean-François / Guilleminault, Laurent

American journal of respiratory and critical care medicine

2023 Volume 207, Issue 9, Page(s) 1253–1255

MeSH term(s)	Humans ; Asthma ; Parasitic Diseases ; Biological Therapy ; Inflammation
Language	English
Publishing date	2023-03-08
Publishing country	United States
Document type	Letter
ZDB-ID	1180953-x
ISSN	1535-4970 ; 0003-0805 ; 1073-449X
ISSN (online)	1535-4970
ISSN	0003-0805 ; 1073-449X
DOI	10.1164/rccm.202210-1898LE
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