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  1. Article: SARS-CoV-2 infection among healthcare workers in India: Limitations of the case-control investigation.

    Niranjan, Viswanathan / Kinnersley, Nelson

    The Indian journal of medical research

    2020  Volume 152, Issue 1 & 2, Page(s) 143–144

    MeSH term(s) Betacoronavirus ; COVID-19 ; Coronavirus Infections/epidemiology ; Health Personnel ; Humans ; India ; Pandemics ; Pneumonia, Viral/epidemiology ; SARS-CoV-2 ; Severe Acute Respiratory Syndrome/epidemiology
    Keywords covid19
    Language English
    Publishing date 2020-08-10
    Publishing country India
    Document type Letter ; Comment
    ZDB-ID 390883-5
    ISSN 0971-5916 ; 0019-5340
    ISSN 0971-5916 ; 0019-5340
    DOI 10.4103/ijmr.IJMR_2360_20
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: SARS-CoV-2 infection among healthcare workers in India

    Niranjan, Viswanathan / Kinnersley, Nelson

    Indian Journal of Medical Research

    Limitations of the case-control investigation

    2020  Volume 152, Issue 1, Page(s) 143

    Keywords General Biochemistry, Genetics and Molecular Biology ; General Medicine ; covid19
    Language English
    Publisher Medknow
    Publishing country in
    Document type Article ; Online
    ZDB-ID 390883-5
    ISSN 0019-5340 ; 0971-5916
    ISSN 0019-5340 ; 0971-5916
    DOI 10.4103/ijmr.ijmr_2360_20
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Safety of oseltamivir in pregnancy: a review of preclinical and clinical data.

    Donner, Barbara / Niranjan, Viswanathan / Hoffmann, Gerhard

    Drug safety

    2010  Volume 33, Issue 8, Page(s) 631–642

    Abstract: Pregnant women with influenza are at increased risk of morbidity, particularly due to respiratory complications. A high excess mortality rate among pregnant women has been observed in previous influenza pandemics and healthcare agencies have provided ... ...

    Abstract Pregnant women with influenza are at increased risk of morbidity, particularly due to respiratory complications. A high excess mortality rate among pregnant women has been observed in previous influenza pandemics and healthcare agencies have provided recommendations on the use of oseltamivir to treat pregnant women who are infected with the pandemic (H1N1) 2009 virus. This article reviews pre-clinical and clinical data to assess the safety of oseltamivir administered during pregnancy, in the context of the effects of influenza on adverse pregnancy outcomes and fetal malformations. The effects of influenza during pregnancy, whether mediated directly by the virus or by fever or other events secondary to the underlying infection, are not yet well understood, but some data indicate an increased risk of birth defects in women infected with influenza during the first trimester. Animal and toxicology studies do not suggest that clinically effective dosages of oseltamivir have the potential to produce adverse effects on fetal development. Additionally, transplacental transfer of the drug and its active metabolite was very limited and not detectable at normal therapeutic doses in an ex vivo human placenta model. To investigate the safety of oseltamivir in pregnancy, the Roche oseltamivir safety database was searched for all exposures to oseltamivir during pregnancy in the 9 years up to 14 December 2008. In addition, a search of the literature was carried out. Of 232 maternal exposures to oseltamivir in the Roche database, pregnancy outcomes were known for 115 of these exposures. The incidence of adverse pregnancy outcomes was as follows: spontaneous abortions 6.1% (7/115), therapeutic abortions 11.3% (13/115) and pre-term deliveries 2.1% (2/94 live births), values that are not higher than background incidence rates. Fetal outcomes were known in 100 of the 232 exposures. For the nine cases of birth defect that were reported, the timing of oseltamivir exposure in relation to the sensitive period for inducing the birth defect was analysed. Two cases of ventricular septal defect, a more common birth defect, and one case of anophthalmos, an uncommon birth defect, were consistent with exposure to oseltamivir during the sensitive period for these birth defects. For other birth defects, there was either no exposure to oseltamivir during the sensitive period for the defect or insufficient information for assessment. These findings were consistent with other reports in the published literature, including a series of 79 Japanese women exposed to oseltamivir during the first trimester. Together with the other evidence reviewed herein, review of the company safety database suggests that oseltamivir is unlikely to cause adverse pregnancy or fetal outcomes, but available data are limited. Clinicians who use oseltamivir in pregnant women should consider the available safety information, the pathogenicity of the circulating influenza virus strain, the woman's general health and the guidance provided by health authorities. Roche will continue to monitor all reports of oseltamivir use during pregnancy.
    MeSH term(s) Animals ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Drug Evaluation, Preclinical/methods ; Female ; Humans ; Influenza A Virus, H1N1 Subtype/drug effects ; Influenza A Virus, H1N1 Subtype/enzymology ; Influenza, Human/epidemiology ; Influenza, Human/prevention & control ; Oseltamivir/adverse effects ; Oseltamivir/therapeutic use ; Pregnancy ; Pregnancy Complications, Infectious/epidemiology ; Pregnancy Complications, Infectious/prevention & control ; Pregnancy Outcome/epidemiology ; Prenatal Exposure Delayed Effects/chemically induced ; Prenatal Exposure Delayed Effects/epidemiology
    Chemical Substances Antiviral Agents ; Oseltamivir (20O93L6F9H)
    Language English
    Publishing date 2010-07-16
    Publishing country New Zealand
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.2165/11536370-000000000-00000
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Safety profile of oseltamivir during the 2009 influenza pandemic.

    Donner, Barbara / Bader-Weder, Silvia / Schwarz, Roman / Peng, Michael M / Smith, James Robert / Niranjan, Viswanathan

    Pharmacoepidemiology and drug safety

    2011  Volume 20, Issue 5, Page(s) 532–543

    Abstract: Purpose: This study evaluated the safety of oseltamivir during the 2009 influenza pandemic.: Methods: Case reports were obtained from the Roche safety database. The incidence of adverse events (AEs) during the pandemic (1 May 2009 to 31 December 2009) ...

    Abstract Purpose: This study evaluated the safety of oseltamivir during the 2009 influenza pandemic.
    Methods: Case reports were obtained from the Roche safety database. The incidence of adverse events (AEs) during the pandemic (1 May 2009 to 31 December 2009) was compared with that beforehand (during previous influenza seasons) for USA and Japan only, as exposure data in other countries were collected inconsistently. Events with significantly higher reporting during the pandemic (lower bound of 95%CI for crude rate ratio >1) were analyzed further.
    Results: Global exposure in the pandemic and prepandemic periods was 18.3 and 64.7 million patients, respectively. In USA and Japan, exposure was 15.5 (1382 cases, 2225 events) and 62.0 million (8387 cases, 12,749 events), respectively. AEs with significantly higher reporting during the pandemic were generally consistent with influenza and its complications and/or with the circulation of a novel virus strain. As might be expected in a pandemic, mortality increased (crude rate ratio, 2.83; 95%CI, 2.23-3.59) versus the prepandemic period. Medical review of serious AEs (fatal or non-fatal outcome) found that most were consistent with pre-existing risk factors, underlying disease, and/or progression of influenza or its complications. Analysis of the remainder did not suggest a causal link with oseltamivir. A review of AEs in previously underexposed subpopulations did not support an association with oseltamivir.
    Conclusions: During the first 8 months of the 2009 influenza pandemic, AEs reported in patients exposed to oseltamivir were consistent with the drug's labeled safety profile, underlying medical conditions, or infection with the pandemic virus.
    MeSH term(s) Adult ; Adverse Drug Reaction Reporting Systems ; Aged ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Infant, Newborn ; Influenza, Human/drug therapy ; Influenza, Human/epidemiology ; Japan/epidemiology ; Male ; Medication Errors/statistics & numerical data ; Middle Aged ; Oseltamivir/administration & dosage ; Oseltamivir/adverse effects ; Oseltamivir/therapeutic use ; Pandemics/prevention & control ; Pandemics/statistics & numerical data ; United States/epidemiology ; Young Adult
    Chemical Substances Antiviral Agents ; Oseltamivir (20O93L6F9H)
    Language English
    Publishing date 2011-05
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1099748-9
    ISSN 1099-1557 ; 1053-8569
    ISSN (online) 1099-1557
    ISSN 1053-8569
    DOI 10.1002/pds.2136
    Database MEDical Literature Analysis and Retrieval System OnLINE

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