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

Yuxin Zhang, Yiping Zhu, Jing Sun
International journal of women's health · 2022 · vol. Volume 14 , pp. 1237–1250 · doi:10.2147/ijwh.s377418 · PMID:36097448 · W4294688166
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⚙ AI-generated summary by claude@2026-06, 2026-06-09 ⓘ

This study analyzed US FDA reports of long-term hormone treatments for endometriosis, finding procedural complications and product issues common, with age and polytherapy associated with specific risks and adverse events.

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Abstract

Purpose: 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.

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Condition tags

endometriosis

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Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

References (64)

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