{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T02:59:01Z","timestamp":1790650741865,"version":"4.1.0"},"reference-count":18,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2016,9,7]],"date-time":"2016-09-07T00:00:00Z","timestamp":1473206400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To compare the patient characteristics and the inter\u2010temporal reporting patterns of adverse events (AEs) for atorvastatin (Lipitor<jats:sup>\u00ae<\/jats:sup>) and sibutramine (Meridia<jats:sup>\u00ae<\/jats:sup>) in social media (AskaPatient.com) versus the FDA Adverse Event Reporting System (FAERS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We identified clinically important AEs associated with atorvastatin (muscle pain) and sibutramine (cardiovascular AEs), compared their patterns in social media postings versus FAERS and used Granger causality tests to assess whether social media postings were useful in forecasting FAERS reports.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We analyzed 998 and 270 social media postings between 2001 and 2014, 69\u2009003 and 7383 FAERS reports between 1997 and 2014 for atorvastatin and sibutramine, respectively. Social media reporters were younger (atorvastatin: 53.9 vs. 64.0\u2009years, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001; sibutramine: 36.8 vs. 43.8\u2009years, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Social media reviews contained fewer serious AEs (atorvastatin, pain: 2.5% vs. 38.2%; sibutramine, cardiovascular issues: 7.9% vs. 63.0%; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001 for both) and concentrated on fewer types of AEs (proportion comprising the top 20 AEs: atorvastatin, 88.7% vs. 55.4%; sibutramine, 86.3% vs. 65.4%) compared with FAERS. While social media sibutramine reviews mentioning cardiac issues helped predict those in FAERS 11\u2009months later (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), social media atorvastatin reviews did not help predict FAERS reports.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Social media AE reporters were younger and focused on less\u2010serious and fewer types of AEs than FAERS reporters. The potential for social media to provide earlier indications of AEs compared with FAERS is uncertain. Our findings highlight some of the promises and limitations of online social media versus conventional pharmacovigilance sources and the need for careful interpretation of the results. \u00a9 2016 The Authors. <jats:italic>Pharmacoepidemiology and Drug Safety<\/jats:italic> published by John Wiley &amp; Sons Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4090","type":"journal-article","created":{"date-parts":[[2016,9,7]],"date-time":"2016-09-07T09:53:16Z","timestamp":1473241996000},"page":"1425-1433","source":"Crossref","is-referenced-by-count":51,"title":["Can social media data lead to earlier detection of drug\u2010related adverse events?"],"prefix":"10.1002","volume":"25","author":[{"given":"Mei Sheng","family":"Duh","sequence":"first","affiliation":[{"name":"Analysis Group, Inc.  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Cremieux","sequence":"additional","affiliation":[{"name":"Analysis Group, Inc.  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc Van","family":"Audenrode","sequence":"additional","affiliation":[{"name":"Groupe d'analyse, Lt\u00e9e  Montr\u00e9al QC Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis","family":"Vekeman","sequence":"additional","affiliation":[{"name":"Groupe d'analyse, Lt\u00e9e  Montr\u00e9al QC Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Karner","sequence":"additional","affiliation":[{"name":"Analysis Group, Inc.  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haimin","family":"Zhang","sequence":"additional","affiliation":[{"name":"Groupe d'analyse, Lt\u00e9e  Montr\u00e9al QC Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Greenberg","sequence":"additional","affiliation":[{"name":"Analysis Group, Inc.  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,9,7]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/amiajnl-2012-001482"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.4015"},{"key":"e_1_2_7_4_1","doi-asserted-by":"crossref","unstructured":"ParkerJ WeiY YatesA FriederO GoharianN.A framework for detecting public health trends with twitter. In: Proceedings of the 2013 IEEE\/ACM International Conference on Advances in Social Networks Analysis and Mining. ASONAM '13. New York NY USA: ACM 2013; 556\u2013563. doi:10.1145\/2492517.2492544.","DOI":"10.1145\/2492517.2492544"},{"key":"e_1_2_7_5_1","unstructured":"U.S. Food and Drug Administration.Science board subcommittee review of the FDA \/ CDER pharmacovigilance program prep FDA Sci board 2011 and mining social media for adverse event surveillance available athttp:\/\/www.fda.gov\/ScienceResearch\/SpecialTopics\/RegulatoryScience\/ucm455305.htm last updated July 17 2015 accessed [Sept. 22 2015]."},{"key":"e_1_2_7_6_1","unstructured":"Innovative Medicines Initiative.9th call for proposals.2013."},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2013.118"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1415"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-014-0203-6"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12746"},{"key":"e_1_2_7_11_1","unstructured":"LoftusP.Lipitor: Pfizer aims to sell over\u2010the\u2010counter version. The Wall Street Journal.http:\/\/www.wsj.com\/articles\/SB10001424052702304071004579410930136742414. Published March 2 2014."},{"key":"e_1_2_7_12_1","unstructured":"U.S. Food and Drug Administration Drug Safety Communication.FDA recommends against the continued use of meridia (sibutramine). FDA Drug Safety Communication. October 8 2010."},{"key":"e_1_2_7_13_1","unstructured":"AskaPatient.com.Terms of use and disclaimer. Available at:http:\/\/www.askapatient.com\/general\/termsofuse.asp. Accessed [April 24 2015]."},{"key":"e_1_2_7_14_1","unstructured":"U.S. Food and Drug Administration.FDA's adverse event reporting system (FAERS).2016: 2\u20135. Available at:http:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Surveillance\/AdverseDrugEffects\/default.htm."},{"key":"e_1_2_7_15_1","unstructured":"U.S. Food and Drug Administration.What is a serious adverse event? FDA Saf Inf adverse event report progr. 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