Safety evaluation of bleomycin in ovarian cancer treatment: A pharmacovigilance analysis using Food and Drug
Xuan Zhou1, Xiaohua Wang1, Luyang Su2
1Department of Gynecology, Affiliated Hospital of Chengde Medical University, China.
Abstract:
Background and AimBleomycin is a cytotoxic antibiotic mainly used for the treatment of carcinoma of the ovary, skin, cervix, vagina, vulva, and penis, as well as malignant lymphoma and testicular cancer. Assessing the real-world safety of bleomycin, particularly in the treatment of ovarian cancer, is essential because of its widespread clinical application. Further investigation of its risk profile in patients with ovarian cancer remains critically important.MethodsThis retrospective, observational pharmacovigilance study was based on data from the Food and Drug Administration Adverse Event Reporting System database. Data were collected from the Food and Drug Administration Adverse Event Reporting System database from the first quarter of 2004 to the third quarter of 2024. The reporting odds ratio, proportional reporting ratio, multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network were used for disproportionality analyses of adverse events related to bleomycin. Additionally, the Weibull distribution was used to model the risk of adverse events over time.ResultsAdverse reactions listed on the official drug label, such as febrile neutropenia, pulmonary toxicity, and respiratory failure, exhibited positive signals. The investigation also identified additional safety concerns not included in the product information, including disseminated intravascular coagulation, acute myeloid leukemia, growing teratoma syndrome, shock, hyperthyroidism, and sarcoidosis. Close surveillance of treatment-related complications, especially during the initial 30 days of therapy, is strongly recommended.ConclusionsOur results are consistent with clinical observations and reveal the emergence of previously unreported adverse event signals associated with bleomycin, along with their demographic and time-to-onset characteristics. Additional population-based medication research is needed to validate these findings.