{"id":411,"date":"2014-02-08T11:51:43","date_gmt":"2014-02-08T11:51:43","guid":{"rendered":"http:\/\/eurekainfomed.it\/?p=411"},"modified":"2026-07-30T14:55:16","modified_gmt":"2026-07-30T14:55:16","slug":"scientific-literature-is-the-foundation-of-pharmacovigilance","status":"publish","type":"post","link":"https:\/\/eurekainfomed.it\/en\/scientific-literature-is-the-foundation-of-pharmacovigilance\/","title":{"rendered":"Scientific literature is the foundation of pharmacovigilance"},"content":{"rendered":"

The occurrence of severe adverse events led to the withdrawal of 19 medicinal products from the European market between 2002 and 2011<\/strong>. Cardiovascular events were responsible for 9 of the 19 withdrawals<\/strong>, while hepatic and psychiatric adverse events each accounted for 4 of the 19 cases<\/strong>.<\/p>\n

\n

Although spontaneous reporting of adverse drug reactions<\/strong> played a key role in withdrawal decisions, clinical studies published in the scientific literature<\/strong> contributed to approximately two-thirds of these regulatory actions.<\/p>\n<\/div>\n

<\/p>\n

A study on case reports highlights the importance of scientific literature<\/span><\/h2>\n

In particular, case reports<\/strong> were cited in 95% of drug withdrawals (18 out of 19 cases)<\/strong>, while randomized clinical trials (RCTs)<\/strong> were cited in 63% (12 of 19 cases)<\/strong>. Meta-analyses<\/strong> contributed to 26% (5 of 19 cases)<\/strong>, whereas case-control studies<\/strong> and cohort studies<\/strong> were each cited in 21% (4 of 19 cases)<\/strong>.<\/p>\n

\n

These findings were published by Rhian McNaughton and colleagues<\/strong> in the British Medical Journal. <\/strong><\/a><\/p>\n

\n

The researchers analyzed the scientific evidence supporting drug withdrawal decisions through searches conducted in PubMed, the websites of the European Medicines Agency (EMA)<\/strong>, and other European regulatory authorities.<\/p>\n

\u201cSpontaneous reports should be used alongside other pharmacovigilance tools, such as observational studies and clinical trials, to more thoroughly evaluate each safety signal, due to the risk of over-reporting, under-reporting, confounding factors, bias, and misclassification.\u201d<\/p><\/blockquote>\n<\/div>\n<\/div>\n

\n

Rhian McNaughton<\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"

The occurrence of severe adverse events led to the withdrawal of 19 medicinal products from the European market between 2002 and 2011. Cardiovascular events were responsible for 9 of the…<\/p>\n","protected":false},"author":1,"featured_media":334,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25,4],"tags":[],"class_list":["post-411","post","type-post","status-publish","format-standard","has-post-thumbnail","category-pharmacovigilance","category-news"],"yoast_head":"\nScientific literature is the foundation of pharmacovigilance<\/title>\n<meta name=\"description\" content=\"A study on case reports highlights the importance of scientific literature in pharmacovigilance and in the identification of ADR\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eurekainfomed.it\/en\/scientific-literature-is-the-foundation-of-pharmacovigilance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Scientific literature is the foundation of pharmacovigilance\" \/>\n<meta property=\"og:description\" content=\"A study on case reports highlights the importance of scientific literature in pharmacovigilance and in the identification of ADR\" \/>\n<meta property=\"og:url\" content=\"https:\/\/eurekainfomed.it\/en\/scientific-literature-is-the-foundation-of-pharmacovigilance\/\" \/>\n<meta property=\"og:site_name\" content=\"Eureka Info Med\" \/>\n<meta property=\"article:published_time\" content=\"2014-02-08T11:51:43+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-30T14:55:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/eurekainfomed.it\/en\/wp-content\/uploads\/2013\/11\/shutterstock_51837310-617x416.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"617\" \/>\n\t<meta property=\"og:image:height\" content=\"416\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" 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