Evaluation of anaphylactic reactions involving carboplatin and paclitaxel reported to the FDA from 1970 to 2023

Introduction Anaphylaxis to carboplatin and paclitaxel are important and potentially life-threatening events that can disrupt chemotherapeutic treatment of gynecologic cancers. Using the FDA Adverse Event Report System (FAERS), we sought to establish the relative incidence of reports of anaphylactic reactions to these drugs compared to other drugs and identify potential associations with age and sex. Methods Using the search terms “anaphylactic reaction”, “anaphylactic shock”, “anaphylactoid reaction”, or “anaphylactoid shock”, we searched FAERS for reports associated with carboplatin or paclitaxel from 1970 until October 2023. Fatal and non-fatal reactions were included. Linear regression evaluated trends in reported cases. Results Of 84,702 anaphylactic events reported to the FDA during the study period, 4,988 (5.9%) were fatal. Carboplatin (1,245 reports) and paclitaxel (1,430 reports) ranked 14th and 9th among all drugs associated with anaphylaxis, and 10th and 3rd among those associated with fatal anaphylaxis (8.0% and 10.6% fatality, respectively). Most reactions occurred in adults aged 18–85 (carboplatin 79.0%; paclitaxel 83.7%), and the majority of affected patients were women (carboplatin 70.4%; paclitaxel 68.8%). From 2013 to 2022, yearly anaphylactic reaction means were 77.9 total and 6.6 fatal carboplatin reports (fatal ratio 0.08), and 84.4 total and 8.2 fatal paclitaxel reports (fatal ratio 0.10). Conclusion The ratio of fatal to total anaphylactic events remained steady over the last decade, suggesting a fatality rate of 8–10% among reports. Additional research is needed to identify biomarkers and improve management of these reactions in gynecologic oncology patients.