BACKGROUND: Cystic fibrosis transmembrane regulator (CFTR) channel modulators (ivacaftor, lumacaftor, tezacaftor and elexacaftor) represent a major advance in the management of cystic fibrosis. However, few data are available on the real-life safety profile of these medications, in particular on adverse events that may lead to their discontinuation. The aim of this study is to describe the characteristics and evolution of adverse reactions to the tezacaftor/ivacaftor/elexacaftor combination that led to discontinuation and were reported to the Centre régional de pharmacovigilance (CRPV) in Rennes (France).
METHODS: A retrospective study was conducted from December 2021 to May 2023, focusing on cases of discontinuation of the tezacaftor/ivacaftor/elexacaftor combination due to the occurrence of one or more adverse effects, and reported to the CRPV of Rennes, France.
RESULTS: Ten cases of drug discontinuation were reported to the Rennes CRPV (6 women/4 men). Adverse effects mainly involved neuropsychiatric disorders (n=6), followed by liver disorders (n=2), ear, nose and throat disorders (n=1), and digestive disorders (n=1). The average duration of treatment at discontinuation was 339.8 [39-668] days. The drug was reintroduced in 7 patients on average 48.7 [7-123] days after discontinuation, with a dosage adjustments (n=4) consisting of changes in dosing times or a reduction in daily doses, with varying success in alleviating adverse symptoms depending on the case.
CONCLUSIONS: This small case series suggests that neuropsychiatric adverse effects may occur more frequently than initially described after initiation of tezacaftor/ivacaftor/elexacaftor, and should be carefully screened and monitored. Dosage or administration schedule modifications may be considered for patients experiencing these adverse effects. Further pharmacovigilance studies are needed to better understand the adverse effect profiles of \"caftors\", their possible risk factors, and the impact of adjusting dosing modalities.

The use of strong opioids in medical units is recurrent, mainly for analgesic purposes. The risk of occurrence of an overdose or an opioid use disorders causes very legitimate concerns for the physician, which may limit the use of opioid treatment or the adaptation of the doses necessary to relieve the patient. We provide a summary of the literature aimed at defining the indications, the adverse effects and the risks involved, the prescribing methods in order to reassure professionals and promote the safe use of these molecules.

BACKGROUND: Asthma is a pathology that remains severe and is inadequately controlled in 4% of patients. Identification of multiple pathophysiological mechanisms has led to the development of biomedicines, of which there are currently five available in France, with a safety profile that appears favorable but remains uncertain due to a lack of real-life experience with these new molecules.
BACKGROUND: Although relatively benign, the adverse effects of biologics are diverse. Headache, joint pain, skin reactions at the injection site, fever and asthenia are commonly observed during the different treatments. Ophthalmological complications seem restricted to dupilumab, with numerous cases of keratitis and conjunctivitis in patients with atopic dermatitis. Several respiratory complications have also been observed, essentially consisting in pharyngitis and other upper respiratory infections. Hypereosinophilia may occur, mainly with dupilumab, requiring investigation of systemic repercussions or vasculitis. Allergic reactions are uncommon but require careful monitoring during initial injections.
CONCLUSIONS: Biologics for severe asthma are recent drugs with a favorable safety profile, but with little real-life experience, justifying increased vigilance by prescribing physicians.

BACKGROUND: The announcement of a cancer diagnosis is traumatic for the patient. In France, an announcement system has been in place, providing medical time for announcement and treatment proposal, nursing time for support, without including the pharmacist. In order to improve management of patients treated with intravenous anticancer drugs, we set up introductory pharmaceutical consultations in digestive oncology. The aims were to assess the situation one year after the introduction of these consultations, and to assess their contribution.
METHODS: When a patient was diagnosed with digestive cancer and receiving intravenous treatment, a pharmaceutical initiation consultation was scheduled. Indicators of activity (number of consultations, average duration, average preparation time and various delays) and results (number and type of pharmaceutical interventions, patient satisfaction) were collected in order to assess activity.
RESULTS: Forty-seven pharmaceutical initiation consultations were carried out. The average duration of the consultations was 39.3minutes. Consultations were carried out on average 12.1 days after the medical consultation and 9.6 days before the first chemotherapy treatment. Twenty-nine patients responded to the satisfaction questionnaire. All were satisfied, and the majority of patients said they had improved their knowledge of cancer treatment.
CONCLUSIONS: This activity enables us to review with patients essential aspects of their care, such as implanting an implantable chamber catheter, anti-cancer treatment and managing potential side effects and improve their self-care skills.

Antidepressant-related sexual dysfunction is one of the most frequently met adverse effects for individuals suffering from major depressive disorder. When primary prevention by non-pharmacological measures fails, empirical coping strategies might be proposed. In this article, we present a brief overview of pharmacological strategies for antidepressant-related sexual dysfunction, considering antidepressants and conceivable corrective medications. We suggest dividing these strategies into three groups: (1) tapering (dose reduction, therapeutic window or short-term treatment interruption); (2) maintenance (focusing on spontaneous remission); (3) optimizing treatment (substitution for another antidepressant or addition of treatments to correct sexual side effects). Whichever strategy is selected, we encourage the clinician to propose the most adequate therapeutic option for the patient, while considering the efficacy and overall tolerance of the current antidepressant strategy, the affected phase of sexuality and patient preferences and gender. This summary is limited to antidepressant treatments and correctors marketed in France and aimed at a clinician reading to help manage patients suffering from antidepressant-induced sexual dysfunction.

Ketamine is now frequently used in the management of chronic pain refractory to conventional treatments. However, its efficacy and adverse effects appear variable in the literature in line with heterogeneous methodologies and modes of administration, leading to controversy regarding the actual interest of ketamine for chronic pain treatment. A need for clinical trials on larger cohorts of well selected patients but also real-life studies to more accurately quantify its efficacy, refine its prescription dosages and better understand its long-term adverse effects is highlighted in the literature. Progress in this direction has been achieved in recent years with improved recommendations for use, taking into account different trajectories of analgesia with ketamine, depending on the etiology of the pain, and the psycho-affective profile of patients. A holistic approach is clearly needed with consideration of pain and depression comorbidities to optimize pain management.
UNASSIGNED: Intérêt de la kétamine dans le traitement des douleurs chroniques.
UNASSIGNED: La kétamine est aujourd’hui fréquemment utilisée dans la prise en charge de la douleur chronique réfractaire aux traitements classiques. Selon les études, l’efficacité et les effets indésirables de la kétamine apparaissent variables, en lien avec des méthodologies et des modes d’administration hétérogènes, conduisant à des controverses sur son utilisation en clinique. Un besoin d’essais sur des cohortes plus nombreuses de patients mieux sélectionnés mais aussi d’études en « vraie vie » pour mieux quantifier son efficacité, raffiner les posologies de prescription et mieux comprendre ses effets indésirables à long terme, est régulièrement souligné dans la littérature. Toutefois, au cours des dernières années, plusieurs travaux ont permis d’avancer sur les recommandations d’utilisation. Ils soulignent en particulier la nécessité de prendre en compte à la fois les trajectoires diverses d’antalgie avec la kétamine, selon l’étiologie de la douleur, et les comorbidités, en particulier la dépression, afin d’optimiser la prise en charge des patients douloureux.

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The development of Oral Cancer Therapies (OAT) raises the question of the therapeutic adherence of patients, put in difficulty by the isolation of the patient in the management of treatment and adverse reactions. Accompanying processes are developing, such as Pharmaceutical Consultations (PC), whose monitoring and education objectives are multiple. The PCs and their implementation are presented here, as well as the first results at 15months. The scope of the PCs was first defined, as well as their organization and supporting documents. A patient\'s medication history is carried out before the PC, then analyzed. The initial PC incorporates a discussion about patient\'s health habits, followed by information on the OAT, which is closed by the delivery of a follow-up diary. The follow-up PCs, distributed over the course of the first year following the initiation, allow to correct the erroneous knowledge of the patient, to support him in his difficulties and to detect any adverse effects. From May 2019 to August 2020, 81.2% of the 32 patients who initiated OAT took part in CP. A pharmacotherapeutic problem is encountered in 65.4% of them and a drug interaction with alternative or complementary medicines in 62.5% of patients which consuming. The PCs developed provide new elements compared to the recommendations and provide support for patients with toxicities that weaken their medical care throughout their care pathway.

BACKGROUND: The Bacillus Calmette-Guérin (BCG) is a live attenuated strain of Mycobacterium bovis. Intravesical therapy with BCG has long been proved to be effective in treating early-stage bladder carcinoma.
METHODS: A 81-year-old male patient with former history of BCG instillations for bladder cancer two years ago was admitted in February 2020 to our department for a pulsatile and painful tumefaction of the right thigh that lasted for 6 months, due to a muscular M. bovis granuloma leading to femoral artery erosion. Emergency vascular surgery associated with prolonged antibiotherapy provided full recovery.
CONCLUSIONS: Late infectious complications of intravesical BCG instillations are classical but rare. Isolated muscular involvement is exceptional.
CONCLUSIONS: Mycobacterial infection should be carefully screened face to a granuloma presenting as muscular pseudotumor. A history of BCG therapy, even decades earlier, enhances this hypothesis and should lead to enforce microbiological testing, especially molecular test.

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