safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)safetyrisk-70Research ArticleОБЗОРЫ И ОРИГИНАЛЬНЫЕ СТАТЬИREVIEWS AND ORIGINAL ARTICLESАнализ спонтанных сообщений о нежелательных реакциях, развившихся при применении лекарственных средств во время беременностиAnalysis of spontaneous reports of adverse reactions, developed in the use of drugs during pregnancyЖуравлеваЕ. О.ZhuravlevaE. O.noemail@neicon.ruВельцН. Ю.VeltsN. Yu.noemail@neicon.ruЗатолочинаК. Э.ZatolochinaK. E.noemail@neicon.ruГлаголевС. В.GlagolevS. V.noemail@neicon.ruПоливановВ. А.PolivanovV. A.noemail@neicon.ruДармостуковаМ. А.DarmostukovaM. A.noemail@neicon.ruЛепахинВ. К.LepakhinV. K.noemail@neicon.ruРомановБ. К.RomanovB. K.noemail@neicon.ruАляутдинР. Н.AlyautdinR. N.noemail@neicon.ruНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральная служба по надзору в сфере здравоохраненияРоссияRoszdravnadzor of the RussiaRussian FederationЦентр по мониторингу эффективного, безопасного и рационального использования лекарственных средствРоссияCenter for Monitoring of Effective, Safety and Rational Use of Medicinal ProductsRussian Federation201720022018526169Copyright © Журавлева Е.О., Вельц Н.Ю., Затолочина К.Э., Глаголев С.В., Поливанов В.А., Дармостукова М.А., Лепахин В.К., Романов Б.К., Аляутдин Р.Н., 20182018Журавлева Е.О., Вельц Н.Ю., Затолочина К.Э., Глаголев С.В., Поливанов В.А., Дармостукова М.А., Лепахин В.К., Романов Б.К., Аляутдин Р.Н.Zhuravleva E.O., Velts N.Y., Zatolochina K.E., Glagolev S.V., Polivanov V.A., Darmostukova M.A., Lepakhin V.K., Romanov B.K., Alyautdin R.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/70

В статье приводятся данные, полученные при ретроспективном анализе спонтанных сообщений (СС) о НР развившихся при применении ЛС во время беременности, поступивших в российскую базу «Фармаконадзор» АИС Росздравнадзор, за период с 1 января 2015 года по 31 декабря 2015 года включительно.

The article presents data obtained in a retrospective analysis of spontaneous messages (SM) on drug adverse reactions during pregnancy, recieved in the Russian base «Pharmacovigilance» AIS Roszdravnadzor, for the period 1 January 2015 to 31 December 2015 included.

беременностьаномалии развитияплодбезопасность лекарственных средствспонтанные сообщенияпротивопоказанияpregnancydevelopmental abnormalitiesfetusafety of drugsspontaneous reportscontraindicationsReferencesAdam MP, Polifka JE, Friedman JM. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet 2011; 157: 175–182.Adam MP, Polifka JE, Friedman JM. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet C Semin Med Genet 2011; 157: 175–182.Daw JR, Hanley GE, Greyson DL, Morgan SG. Prescription drug use during pregnancy in developed countries: a systematic review. Pharmacoepidemiol Drug Saf 2011; 20: 895–902.Daw JR, Hanley GE, Greyson DL, Morgan SG. Prescription drug use during pregnancy in developed countries: a systematic review. Pharmacoepidemiol Drug Saf 2011; 20: 895–902.Lupattelli A, Spigset O, Twigg MJ, Zagorodnikova K, Mardby AC, Moretti ME, et al. Medication use in pregnancy: a cross-sectional, multinational web-based study. BMJ Open 2014; 4: e004365.Lupattelli A, Spigset O, Twigg MJ, Zagorodnikova K, Mardby AC, Moretti ME, et al. Medication use in pregnancy: a cross-sectional, multinational web-based study. BMJ Open 2014; 4: e004365.Pasternak EJ, Alyautdin RN, Romanov BK. Transformation of views on the teratogenicity of antiepileptic therapy. The safety and risk of pharmacotherapy 2014; 4: 12–17.Pasternak EJ, Alyautdin RN, Romanov BK. Transformation of views on the teratogenicity of antiepileptic therapy. The safety and risk of pharmacotherapy 2014; 4: 12–17.Medunitsyn NV, Olefir YuV, Merkulov VA, Bondarev VP. Vaccination contribute to the development of personal and herd immunity. BIOpreparations. Prevention, Diagnosis, Treatment 2016; 16(4): 195–207 (in Russian).Medunitsyn NV, Olefir YuV, Merkulov VA, Bondarev VP. Vaccination contribute to the development of personal and herd immunity. BIOpreparations. Prevention, Diagnosis, Treatment 2016; 16(4): 195–207 (in Russian).Federal law «On circulation of medicines». Federal law No. 429-FZ, 22.12.20146 (in Russian).Federal law «On circulation of medicines». Federal law No. 429-FZ, 22.12.20146 (in Russian).Sokova EA, Bunyatyan ND, Mazerkina IA, Demidova OA, Aleksandrova TV. Clinical trials in pregnancy: evaluation of benefit/risk. Scientific centre for evaluation of medicinal products Bulletin 2015; 4: 26–31 (in Russian).Sokova EA, Bunyatyan ND, Mazerkina IA, Demidova OA, Aleksandrova TV. Clinical trials in pregnancy: evaluation of benefit/risk. Scientific centre for evaluation of medicinal products Bulletin 2015; 4: 26–31 (in Russian).Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics 2002; 110: e53.Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics 2002; 110: e53.Wettach C, Thomann J, Lambrigger-Steiner C, Buclin T, Desmeules J, von Mandach U. Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders. J Perinat Med. 2013; 41(3): 301–7.Wettach C, Thomann J, Lambrigger-Steiner C, Buclin T, Desmeules J, von Mandach U. Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders. J Perinat Med. 2013; 41(3): 301–7.Tkacheva ON, Bevz AYu, Ushkalova EA, Chukhareva N. The first all-Russian pharmacoepidemiological study «Epidemiology of drug use in pregnant women »: the main results. Obstetrics and gynecologists 2011; 4: 112–117. (in Russian)Tkacheva ON, Bevz AYu, Ushkalova EA, Chukhareva N. The first all-Russian pharmacoepidemiological study «Epidemiology of drug use in pregnant women »: the main results. Obstetrics and gynecologists 2011; 4: 112–117. (in Russian)FDA Pregnancy Categories [Electronic source] 2017 (cited 20.01.2017). Avaible at: https://www.drugs.com/pregnancy-categories.html.FDA Pregnancy Categories [Electronic source] 2017 (cited 20.01.2017). Avaible at: https://www.drugs.com/pregnancy-categories.html.

The authors declare that there are no conflicts of interest present.