<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">clinvest</journal-id><journal-title-group><journal-title xml:lang="ru">Качественная клиническая практика</journal-title><trans-title-group xml:lang="en"><trans-title>Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0519</issn><issn pub-type="epub">2618-8473</issn><publisher><publisher-name>ООО «Издательство ОКИ</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">clinvest-132</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>БЕЗОПАСНОСТЬ ЛЕКАРСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>DRUG SAFETY</subject></subj-group></article-categories><title-group><article-title>Обзор сообщений по неблагоприятным побочным реакциям с июня 2009 г. по июнь 2010 г.</article-title><trans-title-group xml:lang="en"><trans-title></trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Колбин</surname><given-names>А. С.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белоусов</surname><given-names>Д. Ю.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff xml:lang="ru" id="aff-1"><institution>Первый Санкт-Петербургский государственный медицинcкий университет имени акад. И.П.Павлова; Санкт-Петербургский государственный университет</institution><country>Russian Federation</country></aff><aff xml:lang="ru" id="aff-2"><institution>ООО "Центр фармакоэкономических исследований", г. Москва</institution><country>Russian Federation</country></aff><pub-date pub-type="collection"><year>2010</year></pub-date><pub-date pub-type="epub"><day>05</day><month>06</month><year>2018</year></pub-date><volume>0</volume><issue>1</issue><fpage>87</fpage><lpage>97</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Колбин А.С., Белоусов Д.Ю., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Колбин А.С., Белоусов Д.Ю.</copyright-holder><copyright-holder xml:lang="en">Колбин А.С., Белоусов Д.Ю.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.clinvest.ru/jour/article/view/132">https://www.clinvest.ru/jour/article/view/132</self-uri><abstract><p>Представлены наиболее важные и интересные сообщения по нежелательным побочным реакциям, собранным за пе­риод 06.2009–06.2010 гг. Агентством по контролю ле­карственных препаратов и пищевых продуктов США (FDA), Европейским Агентством по изучению лекарственных препаратов (EMEA), Агентством по регулированию лекарственных средств и изделий медицинского назначения Великобритании (MHRA) и Федеральным центром мониторинга безопас­ности лекарственных средств РФ (ФЦ МБЛС).</p></abstract><kwd-group xml:lang="ru"><kwd>фармаконадзор</kwd><kwd>мониторинг безопас­ности лекарств</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">.Безопасность лекарств и фармаконадзор . — 2010 . — № 1 . -С . 23–24 .</mixed-citation><mixed-citation xml:lang="en">.Безопасность лекарств и фармаконадзор . — 2010 . — № 1 . -С . 23–24 .</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">.Осложнения фармакотерапии . Неблагоприятные побочные реакции лекарственных средств . Том I//Д . В . Рейхарт, Ю . Б . Белоусов, Д . Ю . Белоусов, С . Б . Болевич, П . А . Воробьев, К . Г . Гуревич, Д . Е . Колода, М . В . Леонова, В . А . Мефодовский, Г . В . Раменская, Е . Р . Рубцова, М . Р . Сакаев — М .: Литтерра, 2007 . — 256 с . — (Серия «Осложнения фармакотерапии») .</mixed-citation><mixed-citation xml:lang="en">.Осложнения фармакотерапии . Неблагоприятные побочные реакции лекарственных средств . Том I//Д . В . Рейхарт, Ю . Б . Белоусов, Д . Ю . Белоусов, С . Б . Болевич, П . А . Воробьев, К . Г . Гуревич, Д . Е . Колода, М . В . Леонова, В . А . Мефодовский, Г . В . Раменская, Е . Р . Рубцова, М . Р . Сакаев — М .: Литтерра, 2007 . — 256 с . — (Серия «Осложнения фармакотерапии») .</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">.Chen H., Wang C., Chuang S., Wang C. Pulmonary embolism after tadalafil ingestion . Pharm World Sci 2008;30 (5):610–2 .</mixed-citation><mixed-citation xml:lang="en">.Chen H., Wang C., Chuang S., Wang C. Pulmonary embolism after tadalafil ingestion . Pharm World Sci 2008;30 (5):610–2 .</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">.Corbin J. D., Francis S. H., Webb D. J. Phosphodiesterase type 5 as a pharmacologic target in erectile dysfunction . Urology . 2002;60 (2 Suppl 2):4–11 .</mixed-citation><mixed-citation xml:lang="en">.Corbin J. D., Francis S. H., Webb D. J. Phosphodiesterase type 5 as a pharmacologic target in erectile dysfunction . Urology . 2002;60 (2 Suppl 2):4–11 .</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">.Drug Safety Update, Volume 3, Issue 5, December 2009, p .3 .</mixed-citation><mixed-citation xml:lang="en">.Drug Safety Update, Volume 3, Issue 5, December 2009, p .3 .</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">.European SmPC of sildenafil (Viagra®). (version date: 13–11–2008) http://www .emea .europa .eu/humandocs/</mixed-citation><mixed-citation xml:lang="en">.European SmPC of sildenafil (Viagra®). (version date: 13–11–2008) http://www .emea .europa .eu/humandocs/</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">.European SmPC of tadalafil (Cialis®). (version date: 13–11–2008) http://www.emea .europa .eu/humandocs/</mixed-citation><mixed-citation xml:lang="en">.European SmPC of tadalafil (Cialis®). (version date: 13–11–2008) http://www.emea .europa .eu/humandocs/</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">.European SmPC of vardenafil (Levitra®). (version date: 19–8-2008) http://www.emea.europa.eu/humandocs/</mixed-citation><mixed-citation xml:lang="en">.European SmPC of vardenafil (Levitra®). (version date: 19–8-2008) http://www.emea.europa.eu/humandocs/</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">.http://labclinpharm.ru</mixed-citation><mixed-citation xml:lang="en">.http://labclinpharm.ru</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">.http://www.apteka .ua</mixed-citation><mixed-citation xml:lang="en">.http://www.apteka .ua</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">. http://www.ema .europa .eu/pressoffice/presshome .htm</mixed-citation><mixed-citation xml:lang="en">. http://www.ema .europa .eu/pressoffice/presshome .htm</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">. http://www.fda .gov</mixed-citation><mixed-citation xml:lang="en">. http://www.fda .gov</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699 .htm</mixed-citation><mixed-citation xml:lang="en">http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699 .htm</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343 .htm</mixed-citation><mixed-citation xml:lang="en">http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343 .htm</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198424 .htm</mixed-citation><mixed-citation xml:lang="en">http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198424 .htm</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm181980.htm</mixed-citation><mixed-citation xml:lang="en">http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm181980.htm</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm186896.htm</mixed-citation><mixed-citation xml:lang="en">http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm186896.htm</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm208703.htm</mixed-citation><mixed-citation xml:lang="en">http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm208703.htm</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">http://www.lareb.nl/</mixed-citation><mixed-citation xml:lang="en">http://www.lareb.nl/</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">. http://www.medvestnik.ru</mixed-citation><mixed-citation xml:lang="en">. http://www.medvestnik.ru</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">. http://www.mhra .gov.uk</mixed-citation><mixed-citation xml:lang="en">. http://www.mhra .gov.uk</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">. http://www.regmed.ru/</mixed-citation><mixed-citation xml:lang="en">. http://www.regmed.ru/</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">. Kovari H. et al. Association of noncirrhotic portal hypertension in HIV-infected persons and antiretroviral therapy with didanosine: a nested case-control study. Clin Infect Dis 49: 626–35, 2009 .</mixed-citation><mixed-citation xml:lang="en">. Kovari H. et al. Association of noncirrhotic portal hypertension in HIV-infected persons and antiretroviral therapy with didanosine: a nested case-control study. Clin Infect Dis 49: 626–35, 2009 .</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">. Press Release Doc. Ref . EMEA/382408/2009, London, 23 .06 .2009</mixed-citation><mixed-citation xml:lang="en">. Press Release Doc. Ref . EMEA/382408/2009, London, 23 .06 .2009</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">. Rufa A., Cerase A., Monti L., Dotti M. T., Giorgio A., Sicurelli F., Federico A. Recurrent venous thrombosis including cerebral venous sinus thrombosis in a patient taking sildenafil for erectile dysfunction . J Neurol Sci 2007;260 (1–2):293–5 .</mixed-citation><mixed-citation xml:lang="en">. Rufa A., Cerase A., Monti L., Dotti M. T., Giorgio A., Sicurelli F., Federico A. Recurrent venous thrombosis including cerebral venous sinus thrombosis in a patient taking sildenafil for erectile dysfunction . J Neurol Sci 2007;260 (1–2):293–5 .</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">. The importance of pharmacoviligance . WHO, 2002</mixed-citation><mixed-citation xml:lang="en">. The importance of pharmacoviligance . WHO, 2002</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">. WHO Pharmaceuticals Newsletter, 2009, № 4, p .1</mixed-citation><mixed-citation xml:lang="en">. WHO Pharmaceuticals Newsletter, 2009, № 4, p .1</mixed-citation></citation-alternatives></ref><ref id="cit28"><label>28</label><citation-alternatives><mixed-citation xml:lang="ru">. WHO Pharmaceuticals Newsletter, 2009, № 4, p .2</mixed-citation><mixed-citation xml:lang="en">. WHO Pharmaceuticals Newsletter, 2009, № 4, p .2</mixed-citation></citation-alternatives></ref><ref id="cit29"><label>29</label><citation-alternatives><mixed-citation xml:lang="ru">. WHO Pharmaceuticals Newsletter, 2009, № 5</mixed-citation><mixed-citation xml:lang="en">. WHO Pharmaceuticals Newsletter, 2009, № 5</mixed-citation></citation-alternatives></ref><ref id="cit30"><label>30</label><citation-alternatives><mixed-citation xml:lang="ru">. WHO Pharmaceuticals Newsletter, 2009, № 3, p .1</mixed-citation><mixed-citation xml:lang="en">. WHO Pharmaceuticals Newsletter, 2009, № 3, p .1</mixed-citation></citation-alternatives></ref><ref id="cit31"><label>31</label><citation-alternatives><mixed-citation xml:lang="ru">. www .emea .europa .eu 32 . www .healtheconomics .ru</mixed-citation><mixed-citation xml:lang="en">. www .emea .europa .eu 32 . www .healtheconomics .ru</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
