{"id":6153,"date":"2014-01-14T09:00:57","date_gmt":"2014-01-14T09:00:57","guid":{"rendered":"http:\/\/wwwen.anm.ro\/?p=6153"},"modified":"2017-05-11T10:53:34","modified_gmt":"2017-05-11T10:53:34","slug":"comunicat-de-presa-14-01-2014-2","status":"publish","type":"post","link":"https:\/\/www.anm.ro\/en\/comunicat-de-presa-14-01-2014-2\/","title":{"rendered":"Press release"},"content":{"rendered":"<p><strong>14.01.2014<\/strong><br \/>\n<span style=\"color: #333399;\"><strong>To the attention of healthcare professionals<\/strong><\/span><br \/>\nOn 10 January 2013, the European Medicines Agency (EMA) issued a press release on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the use of strontium ranelate-containing medicines Protelos and Osseor.<br \/>\nThe PRAC conducted a review of the benefits of these medicinal products, as well as a review of their known risks (myocardial infarction, venous thromboembolism, severe cutaneous reactions) and concluded that the benefit-risk balance for these products is no longer positive, recommending that the use of Protelos\/Osseor be suspended until new data attesting a positive benefit-risk balance for a limited group of patients is available.<br \/>\nWhile in April 2013 the PRAC recommended the restriction in the use of strontium ranelate, following a routine assessment of its benefit-risk balance, in January 2014, following an in-depth review of its safety profile, the European Medicines Agency&#8217;s Pharmacovigilance Risk Assessment Committee recommended the suspension of its use in the treatment of osteoporosis.<br \/>\nAt this stage, until new data becomes available confirming usefulness of this product for a certain population segment is available and until issuance of a European Commission Decision based on the final opinion of EMA\u2019s Committee for Medicinal Products for Human Use (CHMP) to be formulated after its meeting of 20-23 January 2014, physicians are advised to take particular care when prescribing these medicinal products.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>14.01.2014 To the attention of healthcare professionals On 10 January 2013, the European Medicines Agency (EMA) issued a press release [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["post-6153","post","type-post","status-publish","format-standard","hentry","category-comunicate-de-presa"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/6153","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=6153"}],"version-history":[{"count":0,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/posts\/6153\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=6153"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/categories?post=6153"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/tags?post=6153"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}