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  1. Article: Pharmacovigilance.

    Ekobena, Pierre / Ivanyuk, Anton / Livio, Françoise

    Revue medicale suisse

    2021  Volume 17, Issue 720-1, Page(s) 80–84

    Abstract: The main pharmacovigilance updates in 2020 are reviewed. Remdesivir in COVID-19: relatively safe but turns out to be less effective than expected. Hydroxychloroquine in COVID-19 : lack of efficacy and risk of arrhythmias. Cytokines storm in COVID-19: may ...

    Title translation Pharmacovigilance update.
    Abstract The main pharmacovigilance updates in 2020 are reviewed. Remdesivir in COVID-19: relatively safe but turns out to be less effective than expected. Hydroxychloroquine in COVID-19 : lack of efficacy and risk of arrhythmias. Cytokines storm in COVID-19: may impact pharmacokinetics. VEGF inhibitors: risk of aneurysm and artery dissection. Tofacitinib: dose-dependant risk of venous thromboembolic events. Ondansetron in the first trimester of pregnancy : a highly debated risk of orofacial cleft defects. Fingolimod : contraindicated during pregnancy due to suspected risk of congenital malformations. Ranitidine: global market withdrawal due to contamination with nitrosamines. Ulipristal for uterine fibroids : market withdrawal due to risk of severe liver injury. Ingenol mebutate : market withdrawal due to paradoxical risk of skin cancers.
    MeSH term(s) Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; COVID-19/drug therapy ; Cleft Lip/prevention & control ; Contraindications, Drug ; Cytokine Release Syndrome/virology ; Female ; Fingolimod Hydrochloride/adverse effects ; Humans ; Hydroxychloroquine/adverse effects ; Leiomyoma/drug therapy ; Norpregnadienes/therapeutic use ; Pharmacokinetics ; Pharmacovigilance ; Pregnancy ; Ranitidine/adverse effects ; Safety-Based Drug Withdrawals ; Skin Neoplasms/chemically induced
    Chemical Substances Norpregnadienes ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Hydroxychloroquine (4QWG6N8QKH) ; ulipristal (6J5J15Q2X8) ; Ranitidine (884KT10YB7) ; Fingolimod Hydrochloride (G926EC510T) ; Alanine (OF5P57N2ZX)
    Language French
    Publishing date 2021-01-14
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2177010-4
    ISSN 1660-9379
    ISSN 1660-9379
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5998: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Four cases of audio-vestibular disorders related to immunisation with SARS-CoV-2 mRNA vaccines.

    Ekobena, Pierre / Rothuizen, Laura E / Bedussi, Francesca / Guilcher, Pierre / Meylan, Sylvain / Ceschi, Alessandro / Girardin, François / Dao, Kim

    International journal of audiology

    2022  Volume 62, Issue 6, Page(s) 587–591

    Abstract: Objective: To gain medical insight into the clinical course and safety of otolaryngologic disorders following immunisation with severe acute respiratory coronavirus (SARS-CoV-2) mRNA-based vaccines.: Design: Case description.: Study sample: We ... ...

    Abstract Objective: To gain medical insight into the clinical course and safety of otolaryngologic disorders following immunisation with severe acute respiratory coronavirus (SARS-CoV-2) mRNA-based vaccines.
    Design: Case description.
    Study sample: We report four cases of transient audio-vestibular symptoms, which occurred shortly after inoculation of two BNT162b2 (Pfizer-BioNTech
    Results: Hearing loss was unilateral in all cases and recovered at least partially: it was associated with persistent gait instability in two cases, after 1 and 7 months. Trigger mechanisms underpinning audio-vestibular impairment remain uncertain. Immune tolerance mechanisms with off-target innate activation of T-lymphocytes may be involved in vestibulocochlear nerve disorders, as for other cranial nerves involvement.
    Conclusions: The occurrence of audio-vestibular manifestations following mRNA-based vaccines needs ENT monitoring to support their causality in such rare vaccine-related adverse events. Audio-vestibular disorders appeared of transitory nature, including hearing loss, and should not deter further efforts in large-scale vaccination campaigns against SARS-CoV-2.
    MeSH term(s) Humans ; SARS-CoV-2/genetics ; COVID-19 Vaccines/adverse effects ; BNT162 Vaccine ; COVID-19/prevention & control ; Immunization ; Vestibular Diseases/etiology ; Vestibular Diseases/genetics ; Deafness ; RNA, Messenger
    Chemical Substances COVID-19 Vaccines ; BNT162 Vaccine ; RNA, Messenger
    Language English
    Publishing date 2022-05-05
    Publishing country England
    Document type Case Reports ; Journal Article
    ZDB-ID 2073098-6
    ISSN 1708-8186 ; 1499-2027
    ISSN (online) 1708-8186
    ISSN 1499-2027
    DOI 10.1080/14992027.2022.2056721
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 549: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  3. Article: Pharmacovigilance - Vaccins à ARNm contre le Covid-19 : le point sur les effets indésirables.

    Favre, Valérie / Ekobena, Pierre / Chtioui, Haithem / Rothuizen, Laura E / Livio, Françoise / Genton, Blaise / Buclin, Thierry

    Revue medicale suisse

    2022  Volume 18, Issue 767, Page(s) 190–197

    Abstract: The COVID-19 pandemic has stimulated the rapid development and large-scale use of technologically innovative vaccines, such as the mRNA vaccines Spikevax (Moderna) and Comirnaty (Pfizer-BioNTech). This unprecedented deployment has challenged ... ...

    Title translation Pharmacovigilance - mRNA COVID-19 vaccines : current state of knowledge on their adverse effects.
    Abstract The COVID-19 pandemic has stimulated the rapid development and large-scale use of technologically innovative vaccines, such as the mRNA vaccines Spikevax (Moderna) and Comirnaty (Pfizer-BioNTech). This unprecedented deployment has challenged pharmacovigilance, requiring combined skills in safety monitoring, prompt data analysis and continuous dissemination of knowledge. Main recognised adverse events of these vaccines are moderate and transient, linked to their significant reactogenicity. Active post-marketing surveillance has identified rare adverse events such as myopericarditis and a variety of skin reactions. A number of potential rare adverse events are being evaluated and could be retained at the individual level, but do not question the overall safety of these vaccines.
    MeSH term(s) COVID-19 ; COVID-19 Vaccines ; Humans ; Pandemics ; Pharmacovigilance ; RNA, Messenger ; SARS-CoV-2
    Chemical Substances COVID-19 Vaccines ; RNA, Messenger
    Language French
    Publishing date 2022-01-18
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2177010-4
    ISSN 1660-9379
    ISSN 1660-9379
    DOI 10.53738/REVMED.2022.18.767.190
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5998: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

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