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  1. Article: Antidepressant Use During Pregnancy and the Potential Risks of Motor Outcomes and Intellectual Disabilities in Offspring: A Systematic Review.

    Al-Fadel, Nouf / Alrwisan, Adel

    Drugs - real world outcomes

    2021  Volume 8, Issue 2, Page(s) 105–123

    Abstract: Background: There is a risk of adverse neurodevelopmental outcomes in offspring from exposure to antidepressants during pregnancy.: Objective: This study was performed to systematically review the available evidence regarding the impact of in utero ... ...

    Abstract Background: There is a risk of adverse neurodevelopmental outcomes in offspring from exposure to antidepressants during pregnancy.
    Objective: This study was performed to systematically review the available evidence regarding the impact of in utero exposure to antidepressants on motor and intellectual disability outcomes in children.
    Patients and methods: A systematic literature search for published observational studies examining the effects of antidepressants on motor development or intellectual disabilities in children was conducted using the Cochrane Central Register of Controlled Trials, PubMed/Medline, and Google Scholar.
    Results: A total of 14 studies were included in this review. Studies have reported conflicting effects on motor development in infants with maternal exposure to antidepressants. Furthermore, not all of the studies included that assessed intellectual disabilities in infants found an association between maternal exposure to antidepressants and intellectual disabilities. However, methodological flaws existed in the studies, such as the use of scales with inadequate reliability or validity, a lack of statistical power, or confounding by indication or disease severity.
    Conclusion: The available literature provides inconclusive evidence on the relationship between in utero exposure to antidepressants and adverse effects on motor development outcomes or neurocognitive skills. Further observational studies with robust methodologies are needed to comprehensively evaluate the potential risks of prescribing antidepressants during pregnancy.
    Language English
    Publishing date 2021-02-12
    Publishing country Switzerland
    Document type Systematic Review
    ZDB-ID 2806600-5
    ISSN 2198-9788 ; 2199-1154
    ISSN (online) 2198-9788
    ISSN 2199-1154
    DOI 10.1007/s40801-021-00232-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Author Correction: Signal Detection and Assessment of Herb-Drug Interactions: Saudi Food and Drug Authority Experience.

    Alghamdi, Waad / Al-Fadel, Nouf / Alghamdi, Eman A / Alghamdi, Maha / Alharbi, Fawaz

    Drugs - real world outcomes

    2023  Volume 10, Issue 4, Page(s) 587

    Language English
    Publishing date 2023-12-21
    Publishing country Switzerland
    Document type Published Erratum
    ZDB-ID 2806600-5
    ISSN 2198-9788 ; 2199-1154
    ISSN (online) 2198-9788
    ISSN 2199-1154
    DOI 10.1007/s40801-023-00409-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Signal Detection and Assessment of Herb-Drug Interactions: Saudi Food and Drug Authority Experience.

    Alghamdi, Waad / Al-Fadel, Nouf / Alghamdi, Eman A / Alghamdi, Maha / Alharbi, Fawaz

    Drugs - real world outcomes

    2023  Volume 10, Issue 4, Page(s) 577–585

    Abstract: Introduction: Numerous investigations on herbal medicine that have been undertaken in the past several years demonstrate the general acceptance of its safety. The Saudi Food and Drug Authority (SFDA) established the Herb-Drug Interaction (HDI) project ... ...

    Abstract Introduction: Numerous investigations on herbal medicine that have been undertaken in the past several years demonstrate the general acceptance of its safety. The Saudi Food and Drug Authority (SFDA) established the Herb-Drug Interaction (HDI) project to detect and assess potential HDIs to ensure safety. The aim is to detect safety signals and assess them based on available evidence.
    Methods: First, SFDA-registered herbal products (n = 30) were selected and prioritized based on commonly used herbs. Second, reported potential HDIs were retrieved from the World Health Organization global database of individual case safety reports (VigiBase), AdisInsight
    Results: The search yielded 566 potential signals, and 41 had published evidence and were referred for assessment. The assessment results using DIPS were: 22 possible (53.6 %), 7 probable (17%), and 12 doubtful (29.2%) interactions. The recommendation was to include probable HDIs in the product information, including turmeric-tacrolimus, etoposide-Echinacea, Ginkgo biloba-ibuprofen, green tea-warfarin, and licorice-thiazides interactions.
    Conclusion: The HDI project assessed the screening and identification of potential HDIs. The action plan of this project can be used in post-marketing activities to identify potential drug interactions.
    Language English
    Publishing date 2023-10-19
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2806600-5
    ISSN 2198-9788 ; 2199-1154
    ISSN (online) 2198-9788
    ISSN 2199-1154
    DOI 10.1007/s40801-023-00388-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Implementation of risk minimization measures to reduce the risk of tuberculosis among tumor necrosis factor medication users.

    Al-Fadel, Nouf / Almutairi, Abdulaali / Aldhirgham, Tahrir / Abuesba, Laila / Alrwisan, Adel / Alharbi, Fawaz

    Pharmacoepidemiology and drug safety

    2023  Volume 33, Issue 1, Page(s) e5682

    Abstract: Purpose: To examine the adherence to risk minimization measures (RMMs) in newly treated patients with anti-tumor necrosis factor-alpha (anti-TNF-α) medications at one of the largest tertiary care hospitals in Saudi Arabia.: Methods: We included ... ...

    Abstract Purpose: To examine the adherence to risk minimization measures (RMMs) in newly treated patients with anti-tumor necrosis factor-alpha (anti-TNF-α) medications at one of the largest tertiary care hospitals in Saudi Arabia.
    Methods: We included patients who had at least one prescription of infliximab or adalimumab. The index date was the first recorded date of infliximab or adalimumab prescription. New users of anti-TNF-α were divided into pre- and post-RMM implementation groups. The outcome of interest was the proportion of patients that received tuberculosis (TB) screening, including a chest X-ray (CXR) or a QuantiFERON test within 1 month prior to the index date.
    Results: A pre-post RMM implementation comparison of TB screening among infliximab users showed a significant increase in the rates of CXR tests (from 7.5% before RMM implementation to 13.8% after RMM implementation, p < 0.001) and the rates of QuantiFERON tests (4.5% before RMM implementation to 24.1% after RMM implementation, p < 0.001). RMMs were introduced to the study site at the same time as adalimumab was approved and the proportion of patients receiving TB screening was 25.2%.
    Conclusion: TB screening prior to initiation of infliximab or adalimumab was not optimal. However, we noted an improvement in TB screening after the implementation of RMMs for infliximab. Future research may address reasons for low adherence to testing requirements for TB prior to initiation of anti-TNF-α medications.
    MeSH term(s) Humans ; Infliximab/adverse effects ; Adalimumab/adverse effects ; Tumor Necrosis Factor Inhibitors ; Tuberculosis/diagnosis ; Tuberculosis/epidemiology ; Tuberculosis/prevention & control ; Tumor Necrosis Factor-alpha ; Retrospective Studies
    Chemical Substances Infliximab (B72HH48FLU) ; Adalimumab (FYS6T7F842) ; Tumor Necrosis Factor Inhibitors ; Tumor Necrosis Factor-alpha
    Language English
    Publishing date 2023-08-24
    Publishing country England
    Document type Journal Article
    ZDB-ID 1099748-9
    ISSN 1099-1557 ; 1053-8569
    ISSN (online) 1099-1557
    ISSN 1053-8569
    DOI 10.1002/pds.5682
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Jg. 1995 - 2021: Lesesall (2.OG)
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  5. Article: 17-Alpha-Hydroxyprogesterone vs. Placebo for Preventing of Recurrent Preterm Birth: A Systematic Review and Meta-Analysis of Randomized Trials.

    Almutairi, Abdulaali R / Aljohani, Hadir I / Al-Fadel, Nouf S

    Frontiers in medicine

    2021  Volume 8, Page(s) 764855

    Abstract: Background: ...

    Abstract Background:
    Language English
    Publishing date 2021-12-01
    Publishing country Switzerland
    Document type Systematic Review
    ZDB-ID 2775999-4
    ISSN 2296-858X
    ISSN 2296-858X
    DOI 10.3389/fmed.2021.764855
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Evolution of National Guidelines on Medicines Used to Treat COVID-19 in Pregnancy in 2020-2022: A Scoping Review.

    Maisonneuve, Emeline / de Bruin, Odette / Favre, Guillaume / Goncé, Anna / Donati, Serena / Engjom, Hilde / Hurley, Eimir / Al-Fadel, Nouf / Siiskonen, Satu / Bloemenkamp, Kitty / Nordeng, Hedvig / Sturkenboom, Miriam / Baud, David / Panchaud, Alice

    Journal of clinical medicine

    2023  Volume 12, Issue 13

    Abstract: The lack of inclusion of pregnant women in clinical trials evaluating the effectiveness of medicines to treat COVID-19 has made it difficult to establish evidence-based treatment guidelines for pregnant women. Our aim was to provide a review of the ... ...

    Abstract The lack of inclusion of pregnant women in clinical trials evaluating the effectiveness of medicines to treat COVID-19 has made it difficult to establish evidence-based treatment guidelines for pregnant women. Our aim was to provide a review of the evolution and updates of the national guidelines on medicines used in pregnant women with COVID-19 published by the obstetrician and gynecologists' societies in thirteen countries in 2020-2022. Based on the results of the RECOVERY (Randomized Evaluation of COVID-19 Therapy) trial, the national societies successively recommended against prescribing hydroxychloroquine, lopinavir-ritonavir and azithromycin. Guidelines for remdesivir differed completely between countries, from compassionate or conditional use to recommendation against. Nirmatrelvir-ritonavir was authorized in Australia and the UK only in research settings and was no longer recommended in the UK at the end of 2022. After initial reluctance to use corticosteroids, the results of the RECOVERY trial have enabled the recommendation of dexamethasone in case of severe COVID-19 since mid-2020. Some societies recommended prescribing tocilizumab to pregnant patients with hypoxia and systemic inflammation from June 2021. Anti-SARS-CoV-2 monoclonal antibodies were authorized at the end of 2021 with conditional use in some countries, and then no longer recommended in Belgium and the USA at the end of 2022. The gradual convergence of the recommendations, although delayed compared to the general population, highlights the importance of the inclusion of pregnant women in clinical trials and of international collaboration to improve the pharmacological treatment of pregnant women with COVID-19.
    Language English
    Publishing date 2023-07-06
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2662592-1
    ISSN 2077-0383
    ISSN 2077-0383
    DOI 10.3390/jcm12134519
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Implementation of safety standards of compounded sterile preparations in hospital pharmacies: a multinational cross-sectional study.

    Al-Fadel, Nouf / Mahmoud, Mansour A / Dabliz, Rabih / Tabbara, Osama / Aljadhey, Hisham

    European journal of hospital pharmacy : science and practice

    2016  Volume 23, Issue 6, Page(s) 339–342

    Abstract: Objectives: To evaluate implementation of safety standards of compounded sterile preparations in different hospitals.: Methods: This cross-sectional study included 124 hospitals from 19 countries. A survey was developed based on the guidelines and ... ...

    Abstract Objectives: To evaluate implementation of safety standards of compounded sterile preparations in different hospitals.
    Methods: This cross-sectional study included 124 hospitals from 19 countries. A survey was developed based on the guidelines and safety practices of the Institute for Safe Medication Practices (ISMP) for sterile preparations compounding, and was sent to the members of the Intravenous and Parenteral Nutrition experts' network (IV PN experts' network) in the Gulf region and beyond using SurveyMonkey software.
    Results: 124 pharmacists were invited to participate in this study. Only 39 (31.5%) pharmacists from seven countries responded: 16 (41%) of the participants were pharmacy supervisors, and 23 (59%) had >10 years of work experience. However, a majority, 27 (69%), of the respondents were from Saudi Arabia. Written policies and procedures for sterile preparations compounding were available in 37 (95%) hospitals. The concentrated electrolytes were removed from all patient care areas in 28 (72%) hospitals, and 30 (77%) hospitals clearly labelled those as high-alert medications. The use of advanced technologies, such as bar code verification or IV robotics, for compounding sterile preparations were not implemented in 27 (69%) hospitals.
    Conclusions: Minimum standards and best practice recommendations to ensure safety of sterile preparation compounding were implemented in many hospitals of different countries. However, advanced technologies were not implemented by the majority of the hospitals.
    Language English
    Publishing date 2016-03-21
    Publishing country England
    Document type Journal Article
    ZDB-ID 2650179-X
    ISSN 2047-9964 ; 2047-9956
    ISSN (online) 2047-9964
    ISSN 2047-9956
    DOI 10.1136/ejhpharm-2015-000872
    Database MEDical Literature Analysis and Retrieval System OnLINE

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