International Journal of Women's Health (Sep 2022)
Analysis of Adverse Events and Medical Errors in Long-Term Hormone Treatments for Endometriosis: A Study Based on the US Food and Drug Administration Event Reporting System
Abstract
Yuxin Zhang, Yiping Zhu, Jing Sun Shanghai Key Laboratory of Maternal Fetal Medicine, Shanghai Institute of Maternal-Fetal Medicine and Gynecologic Oncology, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, 200092, People’s Republic of ChinaCorrespondence: Jing Sun, Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, 200092, People’s Republic of China, Tel +86 21 20261062, Fax +86 21 50730190, Email [email protected]: To investigate adverse events and medical errors, as well as their possible risk factors, of combined oral contraceptives and progestins used in patients with endometriosis.Patients and Methods: Reports between January 1, 2014 and September 30, 2021 about patients with endometriosis in US Food and Drug Administration Adverse Event Reporting System were analyzed. Disproportional analysis was performed with the Gamma-Poisson Shrinker model to detect overreported drug-event pairs. Logistic regression analysis was utilized to explore potential risk factors.Results: There were 823 reports on long-term hormone treatments and 6247 reports on other drugs after removing duplicates, most of which were reported by consumers and were from the United States. Procedural complications and product issues were common among long-term hormone treatment users, while some other new adverse events emerged in subgroup analysis of different dosage forms of progestin. Polytherapy was negatively associated with off label use (adjusted OR = 0.47, 95% CI 0.22– 0.94) and product use in unapproved indication (adjusted OR = 0.36, 95% CI 0.15– 0.76) for combined oral contraceptive users. Combined oral contraceptive users aged greater than or equal to 30 were less likely to have product use issue (adjusted OR = 0.33, 95% CI 0.12– 0.82) but were at higher risk of pulmonary embolism (adjusted OR = 4.04, 95% CI 1.35– 17.43).Conclusion: Long-term hormone treatment products in this study are generally safe for endometriosis, while newly detected signals need to be validated by further exploration. Patients’ tolerance and fertility desire should be considered when preparing treatment plans.Keywords: adverse side effect, endometriosis, hormone therapy, pharmacovigilance
