Comparison of Online Patient Reviews and National Pharmacovigilance Data for Tramadol-Related Adverse Events: Comparative Observational Study

Abstract

Background Tramadol is known to cause fewer adverse events (AEs) than other opioids. However, recent research has raised concerns about various safety issues. Objective We aimed to explore these new AEs related to tramadol using social media and conventional pharmacovigilance data. Methods This study used 2 data sets, 1 from patients’ drug reviews on WebMD (January 2007 to January 2021) and 1 from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS; January 2016 to December 2020). We analyzed 2062 and 29,350 patient reports from WebMD and FAERS, respectively. Patient posts on WebMD were manually assigned the preferred terms of the Medical Dictionary for Regulatory Activities. To analyze AEs from FAERS, a disproportionality analysis was performed with 3 measures: proportional reporting ratio, reporting odds ratio, and information component. Results From the 869 AEs reported, we identified 125 new signals related to tramadol use not listed on the drug label that satisfied all 3 signal detection criteria. In addition, 20 serious AEs were selected from new signals. Among new serious AEs, vascular disorders had the largest signal detection criteria value. Based on the disproportionality analysis and patients’ symptom descriptions, tramadol-induced pain might also be an unexpected AE. Conclusions This study detected several novel signals related to tramadol use, suggesting newly identified possible AEs. Additionally, this study indicates that unexpected AEs can be detected using social media analysis alongside traditional pharmacovigilance data.

Antiviral influenza treatments and hemorrhage‐related adverse events in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database

“…Adverse events are categorized using the Medical Dictionary for Regulatory Activities (MedDRA) terminology in the FAERS data. The GI hemorrhage adverse events were identified using Standardized MedDRA Queries (SMQ) in the adverse event field 14 . Specifically, the search strategy for identification of GI hemorrhage was querying the adverse event field with SMQ narrow term “gastrointestinal haemorrhage (SMQ).” As there were no IC hemorrhage‐specific SMQ, we followed an approach described by Shimada et al 15 .…”

“…The GI hemorrhage adverse events were identified using Standardized MedDRA Queries (SMQ) in the adverse event field. 14 Specifically, the search strategy for identification of GI hemorrhage was querying the adverse event field with SMQ narrow term "gastrointestinal haemorrhage (SMQ)." As there were no IC hemorrhage-specific SMQ, we followed an approach described by Shimada et al 15 First, we extracted all Preferred Terms (PTs) which are under both MedDRA System Organ Class (SOC) "Nervous System Disorders" and SMQ "Haemorrhage terms (excluding laboratory terms)" (SMQ code: 20000039).…”

Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study

“…So far, most guidelines developed for selecting symptom measures were designed for clinical trials, and there is a lack of guidance for practitioners and for performing surveillance in the real-world clinical setting [ 10 ]. In fact, when the adverse events (AEs) were collected from the real world, new side effects related to the medication use not listed on the drug label have been reported [ 11 ]. Although a subset for practice was recently suggested based on a Delphi study with stakeholder panels [ 12 , 13 ], they only covered common cancers in Western countries, such as breast, lung, and colorectal cancers; further, the guidelines are limited to uncommon cancers, such as lymphoma, stomach, or liver cancers.…”