Data mining for signal detection of adverse events for taxanes based on the food and drug administration adverse drug events reporting system database

ABSTRACTBackground This study aimed to mine and compare the positive signals of adverse drug events (ADE) in paclitaxel, docetaxel, and nab-paclitaxel to evaluate the accuracy of current drug package information inserts and enable clinicians to select the appropriate treatment.Research design and methods ADE data reported from January 2006 to December 2020 were extracted from the Food and Drug Adverse Drug Events Reporting System (FAERS) database, and the reporting odds ratio (ROR) was used to detect the risk signals of the 3 taxanes. The definition relied on system organ class (SOCs) and preferred terms (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA).Results A total of 39,163 case reports on paclitaxel, docetaxel and nab-paclitaxel involving 25 different system organ classes (SOCs) were retrieved from the database. The ADE paclitaxel and nab-paclitaxel reports mainly focused on ‘general disorders and administration site conditions’ and the docetaxel ADE reports focused on ‘skin and subcutaneous tissue diseases.’ Among the three taxanes, nab-paclitaxel had the highest positive signal for serious adverse events.Conclusions Overall, the most common ADE signals and ADE mapping systems obtained in this study were consistent with the package inserts. However, some inconsistencies were noted. Further research is recommended to confirm some of the strong risk signals for ADEs for taxanes before updating the drug package information inserts.KEYWORDS: Taxanespaclitaxeldocetaxelnab-paclitaxelFAERSadverse drug event AcknowledgmentsThis study was performed using the FDA Adverse Event Reporting System (FAERS) database that was provided by the FDA. The information, results, or interpretation of the current study do not represent any opinion of the FDA.Declaration of interestsThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.Reviewer disclosuresOne reviewer has disclosed the following: advisory board: EMD Serono, BMS, Merck, Seattle Genetics/Astellas, Janssen, Bicycle Therapeutics, Pfizer, Gilead, Scholar Rock, G1 Therapeutics, Eli Lilly/Loxo Oncology, Lucence Health, IMV, and Vial; consultant/scientific advisory board (SAB): Suba Therapeutics, and Syapse; research support to institution: Sanofi, AstraZeneca, Gilead, Helsinn, Lucence, EMD Serono, Jazz Therapeutics, and Genecentric; speaker: BIO – INFORMAÇÃO BRASILEIRA DE ONCOLOGIA Ltda, Seagen, Gilead, Natera, and Exelixis; data safety monitoring committee (honorarium): Mereo; employment: spouse employed by Myriad; writing/editor fees: Uptodate, Editor of Elsevier Practice Update Bladder Cancer Center of Excellence. The remaining peer reviewers on this manuscript have no relevant financial or other relationships to disclose.Authors’ contributionsWang LY and Liao LF carried out the design of this study, data acquisition, data analysis and manuscript preparation; Lei CL provided assistance for data acquisition, data analysis and statistical analysis; Wu Q and Guo YJ carried out literature search, data acquisition and manuscript editing; Li Y conceived and designed the study and manuscript review. All authors have read and agreed to the published version of the manuscript. All authors agree to be accountable for the content of the work.Data availability statementThe data that support the findings of this study can be accessed upon request to the Food and Drug Administration or through the OpenVigil platform [http://openvigil.sourceforge.net].EthicsInstitutional review board approval was waived for this study because FAERS is a public anonymized database.Additional informationFundingThis study was supported by 2021 Guangxi Drug Safety Research Project and Guangxi Medical and Health Appropriate Technology Development, Promotion and Application Project (Guangxi Health Commission of China; no.S2018082).