{"id":405319,"date":"2025-09-07T13:23:12","date_gmt":"2025-09-07T13:23:12","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/405319\/"},"modified":"2025-09-07T13:23:12","modified_gmt":"2025-09-07T13:23:12","slug":"why-is-there-an-inquiry-into-the-use-of-epilepsy-drug-sodium-valproate-the-irish-times","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/405319\/","title":{"rendered":"Why is there an inquiry into the use of epilepsy drug sodium valproate? \u2013 The Irish Times"},"content":{"rendered":"<p>I heard recently there\u2019s an inquiry into sodium valproate, what\u2019s this about?<\/p>\n<p class=\"c-paragraph paywall \">The inquiry relates to the historical licensing and use of the anti-epileptic drug sodium valproate, or Epilim, for women of childbearing age.<\/p>\n<p class=\"c-paragraph paywall \">Despite studies since the late 1980s that showed significantly increased risks foetal malformations where pregnant women took this drug, women of childbearing age were not warned until recent years.<\/p>\n<p>Why are the risks associated with it?<\/p>\n<p class=\"c-paragraph paywall \">Foetal valproate spectrum (FVS) disorder is caused by exposure in the womb to valproic acid, which is the key ingredient in sodium valproate.<\/p>\n<p class=\"c-paragraph paywall b-it-article-body__text--left\">FVS is characterised by distinct deep-set facial features, physical malformations, developmental delay and <a href=\"https:\/\/www.irishtimes.com\/tags\/autism\/\" target=\"_self\" rel=\"noopener\" title=\"https:\/\/www.irishtimes.com\/tags\/autism\/\">autism<\/a>, and can mean lifelong care.<\/p>\n<p>Is it a wide-scale issue?<\/p>\n<p class=\"c-paragraph paywall \">A 2021 report published in the Irish Medical Journal, based on Irish birth data from 1975 to 2015, suggests that 3,126 babies were potentially exposed to valproic acid in-utero in that time period. Of these, 873 were born between 2000 and 2015.<\/p>\n<p class=\"c-paragraph paywall \">Between 153 and 341 babies may have experienced some form of major congenital malformation from 1975 to 2015, the study said, while 1,250 may have experienced some form of neurodevelopmental delay during this time period.<\/p>\n<p>Is this a problem only in Ireland?<\/p>\n<p class=\"c-paragraph paywall b-it-article-body__text--left\">No. Inquiries on the drug have already taken place in other countries, including in France and in Britain.<\/p>\n<p>So when did the inquiry start?<\/p>\n<p class=\"c-paragraph paywall \">It has been a long journey. Affected families have been calling for an inquiry to find out who knew what and when about the drug since 2019.<\/p>\n<p class=\"c-paragraph paywall b-it-article-body__text--left\">In 2020, then minister for health <a href=\"https:\/\/www.irishtimes.com\/tags\/stephen-donnelly\/\" target=\"_self\" rel=\"noopener\" title=\"https:\/\/www.irishtimes.com\/tags\/stephen-donnelly\/\">Stephen Donnelly<\/a> announced his commitment to holding an inquiry into the historical licensing and use of Epilim in Ireland. Terms of reference were accepted by families in late 2022.<\/p>\n<p class=\"c-paragraph paywall b-it-article-body__text--left\">In June 2024, barrister Br\u00edd O\u2019Flaherty was appointed as chairwoman of the inquiry. But it was a year later, in July 2025, before the inquiry began its work.<\/p>\n<p>So what is it going to look at?<\/p>\n<p class=\"c-paragraph paywall b-it-article-body__text--left\">It will involve three distinct phases, and the <a href=\"https:\/\/www.irishtimes.com\/tags\/department-of-health\/\" target=\"_self\" rel=\"noopener\" title=\"https:\/\/www.irishtimes.com\/tags\/department-of-health\/\">Department of Health<\/a> expects it will spend 12 to 18 months conducting an \u201cindependent, fair and rigorous process\u201d.<\/p>\n<p class=\"c-paragraph paywall \">The first phase will establish a timeline for the use of sodium valproate in women of childbearing potential in the State, including information on regulation, prescribing, dispensing and safety information issued.<\/p>\n<p class=\"c-paragraph paywall \">The second phase will focus on oral statements from people diagnosed with FVSD, their mothers and other family members.<\/p>\n<p class=\"c-paragraph paywall \">The final strand will assess the health service\u2019s capacity to respond to safety issues related to the use of anti-seizure medications in women of child-bearing potential.<\/p>\n<p>Will there be a redress scheme?<\/p>\n<p class=\"c-paragraph paywall b-it-article-body__text--left\">That still remains to be seen. However, Donnelly previously said the Government must \u201cabsolutely be open\u201d to establishing a redress scheme if an inquiry into the historical licensing and use of an anti-epilepsy drug among pregnant women finds \u201csystemic issues\u201d.<\/p>\n","protected":false},"excerpt":{"rendered":"I heard recently there\u2019s an inquiry into sodium valproate, what\u2019s this about? The inquiry relates to the historical&hellip;\n","protected":false},"author":2,"featured_media":405320,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4315],"tags":[663,34912,105,4326,129294,16,15,37368],"class_list":{"0":"post-405319","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-autism","9":"tag-department-of-health","10":"tag-health","11":"tag-medication","12":"tag-stephen-donnelly","13":"tag-uk","14":"tag-united-kingdom","15":"tag-weekendreview"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/115163234694098506","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/405319","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=405319"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/405319\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/405320"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=405319"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=405319"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=405319"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}