{"id":1564,"date":"2019-02-21T00:00:00","date_gmt":"2019-02-20T22:00:00","guid":{"rendered":"http:\/\/interchem.epicstation.com\/news\/informaciya-gosudarstvennogo-ekspertnogo-centra-mz-ukraini-otnositelno-preparatov-soderjaschih-fenspirid-v-es\/"},"modified":"2019-02-21T00:00:00","modified_gmt":"2019-02-20T22:00:00","slug":"informaciya-gosudarstvennogo-ekspertnogo-centra-mz-ukraini-otnositelno-preparatov-soderjaschih-fenspirid-v-es","status":"publish","type":"news","link":"https:\/\/interchem.ua\/en\/news\/informaciya-gosudarstvennogo-ekspertnogo-centra-mz-ukraini-otnositelno-preparatov-soderjaschih-fenspirid-v-es\/","title":{"rendered":"Information of the State Expert Center of the MoH Ukraine about the drugs which contain fenspiridum, in the EU"},"content":{"rendered":"<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">EMA&rsquo;s safety committee (PRAC) has recommended an EU-wide suspension of fenspiride medicines, used in children and adults to relieve cough caused by lung diseases. The suspension is a precautionary measure to protect patients while the PRAC reviews the risk of QT prolongation and torsades de pointes (abnormalities of the heart&rsquo;s electrical activity that may lead to heart rhythm disturbances).<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">Cases of heart rhythm problems had been reported in patients who had taken these medicines in the past. To explore the potential link between fenspiride and these heart rhythm problems, animal studies were carried out which now show that fenspiride has the potential to prolong QT in humans. <\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">The PRAC will now examine all the available evidence and make recommendations on the action to be taken on marketing authorisations for fenspiride medicines across the EU. Once the review is concluded, EMA will communicate further and provide updated guidance to patients and healthcare professionals.<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><strong><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">Information for patients<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/strong><\/span><\/span><\/p>\n<ul>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">Safety data indicate that cough medicines containing fenspiride could cause sudden serious heart rhythm problems. <\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">While authorities review all the evidence, patients are advised to stop taking these medicines.<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">Patients are only at risk of heart rhythm problems with fenspiride while they are taking these medicines. <\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">If you are taking a cough medicine containing fenspiride, contact your doctor or pharmacist for advice on alternative treatments, if needed.<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">If you have any concerns about your medicine, discuss them with your doctor or pharmacist.<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><strong><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">Information for healthcare professionals<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/strong><\/span><\/span><\/p>\n<ul>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">As a precaution and while the review is ongoing, healthcare professionals should advise their patients to stop taking fenspiride medicines. <\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">The provisional suspension of fenspiride medicines is based on recent nonclinical studies (hERG channel binding and in vitro animal model studies) that showed that fenspiride has the potential to increase QT intervals in humans. These data were supportive of a previously suspected link between fenspiride and QT prolongation\/torsades de pointes in humans, which was based on a limited number of case reports. <\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">Given the authorised use of fenspiride for symptomatic treatment only and the seriousness of QT prolongation, the medicines are provisionally suspended pending the results of an urgent EU safety review. <\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p lang=\"zxx\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">Healthcare professionals will be informed in writing about the suspension, and further information will be provided as needed and once the review has concluded.<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p lang=\"en-US\" align=\"justify\"><span><span style=\"font-size: small;\"><span><span style=\"color: #2a2a2a;\"><span><span><span><span style=\"font-family: 'Times New Roman', serif;\">Link:<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p lang=\"uk-UA\" align=\"justify\"><span><span style=\"font-size: small;\"><a href=\"https:\/\/www.ema.europa.eu\/documents\/referral\/fenspiride-containing-medicinal-products-article-107i-referral-suspension-fenspiride-medicines-due_en.pdf\"><span><span style=\"color: #2a2a2a;\"><span><span><span lang=\"ru-RU\"><span><span style=\"font-family: 'Times New Roman', serif;\">https:\/\/www.ema.europa.eu\/documents\/referral\/fenspiride-containing-medicinal-products-article-107i-referral-suspension-fenspiride-medicines-due_en.pdf<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/a><\/span><\/span><\/p>\n","protected":false},"featured_media":954,"template":"","class_list":["post-1564","news","type-news","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Information of the State Expert Center of the MoH Ukraine about the drugs which contain fenspiridum, in the EU<\/title>\n<meta name=\"description\" content=\"interchem, fenspiridum, moh, \u0434\u0435\u0446, \u041c\u041e\u0417 \u0423\u043a\u0440\u0430\u0457\u043d\u0438\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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