Statin-related AEs reported on Twitter support regulatory data
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Statin-related AEs reported on Twitter support regulatory data HMG-CoA reductase inhibitor (statin)-related adverse events (AEs) reported in Twitter generally support regulatory data but may also provide useful information on AEs that are most pertinent to patients, say authors of a study published in Drug Safety. Investigators collected data on statin-related AEs reported on Twitter (12 649 tweets) between June 2013 and August 2018, and from the US FDA Adverse Event Reporting System (FAERS; 45 447 reports), the UK Medicines and Healthcare products Regulatory Agency (MHRA; 10 415 reports), two drug information databases (Facts and Comparisons, and Clinical Pharmacology) and 17 systematic reviews. The proportion and relative frequencies of AEs from each source were compared for atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin, as well as for cerivastatin which was withdrawn from the market. The most frequently used MeDRA preferred terms for statin-related AEs on FAERS were myalgia, rhabdomyolysis, drug interaction, fatigue, muscle spasm, pain in extremities, arthralgia, asthenia, muscular weakness, acute kidney injury and dizziness. Compared with other data sources, Twitter reports were frequently about musculoskeletal symptoms than other AEs. However, most AEs showed a high level of agreement between Twitter and regulatory data, while drug information databases demonstrated similar patterns but not as strongly. The term ’Musculoskeletal and connective tissue disorders’ was mentioned 21.7 times the index comparator in Twitter, 3.82 times the index in FAERS, 3.61 times the index in MHRA and 5.96 times the index in drug information databases. Systematic reviews were more likely to assess pre-specified AEs or those reported by trial investigators. "Social media may provide information about medications that supports what is known and also potentially useful information not readily available from traditional sources including adverse events of most concern to patients," the authors commented. Golder S, et al. A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews. Drug 803507714 Safety : Oct 2020. Available from: URL: http://doi.org/10.1007/s40264-020-00998-1
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Reactions 17 Oct 2020 No. 1826
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