Publications by authors named "Perault-Pochat M"

Background: Data on drug-induced reversible cerebral vasoconstriction syndrome (RCVS) are scarce. We aimed to describe RCVS characteristics with drugs previously identified as associated with RCVS and investigate potential signals related to other drugs.

Methods: VigiBase was queried for all reports of RCVS until 31 May 2023.

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Impulsivity dimensions have been shown to be associated with smoking status and tobacco use disorder severity. However, it is important to determine the specific impulsivity traits associated with smoking relapse. This study aimed at investigating the associations between impulsivity traits and smoking cessation success among adult smokers at 12 months after a quit attempt.

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  • Ketamine is increasingly being used non-medically, especially among individuals with substance use disorders, with a notable rise in users from 2012 to 2021 according to data from the OPPIDUM program.
  • Analysis of the French National Pharmacovigilance Database between 2020 and 2022 revealed that a significant proportion of ketamine cases involved complications like ketamine use disorder and symptoms related to urinary and liver issues.
  • The findings highlight a concerning trend of growing ketamine use among substance users and associated health complications, although the overall non-medical use rates in the general population remain unclear.
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Background: Data on the risk of invasive fungal infections (IFI) with ibrutinib treatment are scarce.

Objectives: This study aimed to determine IFI incidence and risk factors in ibrutinib-treated patients in real-life settings.

Methods: We constituted a cohort of ibrutinib incident users in the French National Healthcare Database.

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  • - The study examined the effects of recreational cannabis use during pregnancy on adverse outcomes using data from Poitiers University Hospital from 2010 to 2019.
  • - Pregnant women using cannabis had characteristics such as being younger, having a lower pre-pregnancy BMI, and a higher psychiatric history compared to those using only tobacco or not using either substance.
  • - Results showed that cannabis use was linked to increased risks of pregnancy complications including voluntary interruptions, adverse events during pregnancy, and issues like prematurity and low birth weight.
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  • A nationwide study evaluated the safety of using ibrutinib alongside anticoagulants, focusing on the risk of clinically relevant bleeding (CRB).
  • The study identified 614 cases of CRB from patients hospitalized for bleeding, and matched them with 2407 controls based on age, sex, and follow-up duration.
  • Results indicated a significant risk increase for CRB in patients on both ibrutinib and anticoagulants, with the odds being particularly high for parenteral anticoagulants (3.40 times higher risk).
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  • This study investigates immune checkpoint inhibitor (ICI)-related cytopenias, which are underreported blood disorders linked to cancer treatments, using data from the French pharmacovigilance database up to March 2022.
  • Among 68 patients with grade ≥ 2 cytopenias, the most common conditions noted were immune thrombocytopenia (50.7%) and autoimmune hemolytic anemia (25.3%), with nearly 50% of cases being severe (grade ≥ 4).
  • The research highlights that while ICI-related cytopenias can be serious and life-threatening, a significant number (72.1%) showed improvement with conventional treatments, although relapses occurred in some patients after restarting ICIs.
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Cannabis is the main illicit psychoactive substance used by pregnant women in France. The aim of the present national survey was to describe adverse events (AEs) of recreational cannabis use during pregnancy reported to the French Addictovigilance Network (FAN). Spontaneous reports (SRs) of AEs related to recreational cannabis use during pregnancy were collected by the FAN between 01/01/2011 and 31/01/2021 (excluding cannabidiol and synthetic cannabinoids).

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Data on venous thromboembolic events (VTEs) in patients receiving immune checkpoint inhibitors (ICIs) are scarce and conflicting. This study investigated the risk of reporting VTEs associated with ICIs in comparison with all other anticancer drugs. The World Health Organization pharmacovigilance database (VigiBase), comprising >30 million individual case safety reports, was queried.

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  • Precarious patients face challenges in healthcare due to low literacy and poor treatment adherence, leading to difficulties for general practitioners in communication and prescribing.
  • A study in 2015 analyzed drug prescriptions from GPs in regions with varying levels of precariousness, showing that high precariousness significantly influenced prescriptions, with nine drugs over-prescribed to precarious patients.
  • The findings suggest that GPs might over-prescribe easy-to-take medications to help compensate for low compliance, while also neglecting essential treatments for certain conditions in both precarious and non-precarious populations due to factors like burnout and loss of empathy.
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Immune checkpoint inhibitors (ICIs) have become the standard of care for several types of cancer due to their superiority in terms of survival benefits in first- and second-line treatments compared to conventional therapies, and they present a better safety profile (lower absolute number of grade 1-5 adverse events), especially if used in monotherapy. However, the pattern of ICI-related adverse events is totally different, as they are characterized by the development of specific immune-related adverse events (irAEs) that are unique in terms of the organs involved, onset patterns, and severity. The decision to resume ICI treatment after its interruption due to irAEs is challenged by the need for tumor control versus the risk of occurrence of the same or different irAEs.

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  • The study focused on analyzing the safety profile of ibrutinib, a drug used for treating B-cell malignancies, using a large pharmacovigilance database to identify potential safety signals.
  • A total of 16,196 serious individual case safety reports from patients aged 18 and older were assessed between 2013 and 2020, revealing that the median age of patients was 72.9 years, with significant findings regarding hospitalizations.
  • Among the 713 identified safety signals, 36 potential risks linked to ibrutinib treatment were found, including heart diseases, pericarditis, and fractures, indicating the need for enhanced patient monitoring and further research for validation.
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  • - The study examines the effectiveness of serotonin reuptake inhibitors (SRIs) in treating obsessive-compulsive disorder (OCD), noting that a significant number of patients do not respond well to these medications.
  • - Researchers focused on how a specific genetic variation, the BDNF Val66Met polymorphism, influences treatment outcomes in OCD patients over a 6-month period.
  • - Results showed no significant link between the BDNF genotype and overall treatment response, but suggested that patients with the Met allele may experience better outcomes specifically in the aggressive/checking symptoms of OCD after 6 months.
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Aims: To describe the adverse events (AEs) of recreational cannabis use in France between 2012 and 2017.

Methods: AEs related to recreational cannabis use, alone or in combination with alcohol and/or tobacco reported to the French Addictovigilance Network were analysed (excluding cannabidiol and synthetic cannabinoids).

Results: Reporting of AEs tripled between 2012 (n = 179, 6.

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Background: Safety of rechallenge of immune checkpoint inhibitor (ICI) after grade ≥2 immune-related adverse events (irAEs) leading to ICI discontinuation remains unclear.

Methods: All adverse drug reactions involving at least one ICI reported up to December 31, 2019 were extracted from the French pharmacovigilance database. Patients were included if they experienced at least one grade ≥2 irAE resulting in ICI discontinuation, with subsequent ICI rechallenge.

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  • The study aimed to gather real-life data on how ibrutinib is used and its safety profiles in patients between November 2014 and November 2018.
  • A total of 102 patients participated, mainly receiving ibrutinib for chronic lymphocytic leukemia (CLL), with 47.1% experiencing serious adverse drug reactions (SADRs) within the first year.
  • The findings highlighted that older patients (aged ≥80) and those with CLL had a higher risk of developing SADRs, indicating that they require closer monitoring during treatment.
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Introduction: According to French guidelines on good pharmacovigilance practices, a pharmacovigilance survey is an assessment of the available drug safety data. It is requested by the French national agency for medicines and health products safety (ANSM). The objective is to validate a signal, to characterize it, or to provide strengthened monitoring of a drug.

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: The French Universal Health Cover (CMU) aims to compensate for inequalities between precarious and non-precarious populations, enabling the former to access to free healthcare. These measures rely on the principle that precarious populations' health improves if healthcare is free. We designed a study to examine whether CMU fails to compensate for inequalities in reimbursed drugs prescriptions in precarious populations.

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Hearing loss is defined as a decrease in the ability to perceive sounds which can occur suddenly or gradually and affects one ear or both. It is related to various etiologies, in particular drugs. The identification of all drugs that could be associated with hearing loss is essential for the patients' life quality.

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Aims: Despite fluoropyrimidines (FPs) constituting the main component of the chemotherapy combination protocols in 50% of chemotherapies for solid tumour treatments, incidence data for FP-related toxicity are poorly documented in real life. This study evaluated the number of patients receiving FP-based chemotherapies in France, along with the true incidence of FP-related serious adverse effects (SAEs) before the recent mandatory dihydropyrimidine dehydrogenase (DPD)-screening was introduced by French health authorities, DPD being the rate-limiting enzyme of 5-fluorouracil (5-FU) catabolism.

Methods: Exhaustive data on the number of patients treated with FP-based chemotherapy in 2013-2014 were collected in the Centre-Val de Loire region of France.

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