Dolutegravir
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Neural tube defects following in-utero exposure: 6 case reports In a study of patients reviewed from VigiAccess, EudraVigilance, UK MHRA and FAERS between June 2018 and August 2018, six patients [including one male neonate, one 12-month-old infant and three neonates; not all ages and sexes stated] were described, who developed neural tube defects (NTDs) presenting as anencephaly, iniencephaly, meningocele, encephalocele and spina bifida following in-utero exposure to dolutegravir antiretroviral therapy. The mothers of the patients were receiving antiretroviral therapy with dolutegravir (5 patients) and dolutegravir and methyldopa [1 patient; dosages and routes not stated]. Subsequently, the women gave birth to neonates, who showed NTDs secondary to inutero exposure to dolutegravir. Amongst the 6 patients, a patient from Namibia developed anencephaly following in-utero exposure to dolutegravir [Tivicay], and a male patient from USA developed unspecified NTD with meningocele on 5 May 2018, resulting in hospitalisation. Three neonates from Botswana, developed iniencephaly (1 patient), anencephaly (1 patient) and spina bifida (1 patient) between 16 October 2017 and 12 January 2018, resulting in their death. The remaining one infant aged 12 months developed encephalocele on 16 April 2018 in Botswana [not all outcomes stated]. van de Ven NS, et al. Analysis of pharmacovigilance databases for dolutegravir safety in pregnancy. Clinical Infectious Diseases 70: 2599-2606, No. 12, 15 Jun 2020. 803518955 Available from: URL: http://doi.org/10.1093/cid/ciz684
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Reactions 5 Dec 2020 No. 1833
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