Abstract
PurposeTo compare the patient characteristics and the inter‐temporal reporting patterns of adverse events (AEs) for atorvastatin (Lipitor®) and sibutramine (Meridia®) in social media (AskaPatient.com) versus the FDA Adverse Event Reporting System (FAERS).MethodsWe 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.ResultsWe analyzed 998 and 270 social media postings between 2001 and 2014, 69 003 and 7383 FAERS reports between 1997 and 2014 for atorvastatin and sibutramine, respectively. Social media reporters were younger (atorvastatin: 53.9 vs. 64.0 years, p < 0.001; sibutramine: 36.8 vs. 43.8 years, p < 0.001). Social media reviews contained fewer serious AEs (atorvastatin, pain: 2.5% vs. 38.2%; sibutramine, cardiovascular issues: 7.9% vs. 63.0%; p < 0.001 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 months later (p < 0.001), social media atorvastatin reviews did not help predict FAERS reports.ConclusionsSocial media AE reporters were younger and focused on less‐serious 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. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
Highlights
Regulators have shown increasing interest in mining data from support group websites and social media postings as potential new sources for analyzing drug safety, patient-reported outcomes, and drug use experiences.[1,2,3] For example, the United States Food and Drug Administration (FDA) has stated that there is a public health interest in Internet-based data and has funded the development of software to mine social media data for safety signals.[4]
We compared the patient characteristics and patterns of adverse events (AEs) reporting for two medications, atorvastatin (Lipitor®, a lipid-lowering agent first approved in the USA in December 1996, manufactured by Pfizer, New York City, New York, United States) and sibutramine (Meridia®, a weight loss drug first approved in the USA in November 1997, manufactured by Abbott Laboratories, Abbott Park, Illinois, United States), in a social media data source with those in FDA FDA Adverse Event Reporting System (FAERS) reports
We used Granger causality tests to assess the association between the numbers of FAERS reports in a given month and social media postings in prior months, conditional on other available prior information
Summary
Regulators have shown increasing interest in mining data from support group websites and social media postings as potential new sources for analyzing drug safety, patient-reported outcomes, and drug use experiences.[1,2,3] For example, the United States Food and Drug Administration (FDA) has stated that there is a public health interest in Internet-based data and has funded the development of software to mine social media data for safety signals.[4]. Leveraging social media data for pharmacovigilance requires an understanding of their strengths and weaknesses relative to conventional data sources, such as the FDA Adverse Event Reporting System (FAERS).[6] the existing literature comparing social media and conventional pharmacovigilance data sources is limited to the comparison of the reporting characteristics without further investigating the inter-temporal relationship of the reporting pattern between these sources.[7,8,9] The objective of this study is to shed light on the potential role of social media data in pharmacovigilance, including their ability to m. Accelerate the detection of drug-related AEs. We compared the patient characteristics and patterns of AE reporting for two medications, atorvastatin (Lipitor®, a lipid-lowering agent first approved in the USA in December 1996, manufactured by Pfizer, New York City, New York, United States) and sibutramine (Meridia®, a weight loss drug first approved in the USA in November 1997, manufactured by Abbott Laboratories, Abbott Park, Illinois, United States), in a social media data source with those in FDA FAERS reports
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
