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Post-Menopausal Vaginal Hemorrhage Related to the Use of a Hop-Containing Phytotherapeutic Product

Authors :
Florence van Hunsel
Sonja van de Koppel
Eugène van Puijenbroek
Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)
Source :
Drug Safety-Case Reports, Drug Safety-Case Reports, 2(1):14. Springer International Publishing
Publication Year :
2016

Abstract

Two 54-year-old women developed abdominal cramps and vaginal hemorrhage as a result of endometrial hyperplasia during treatment with a hop-containing phytotherapeutic product (MenoCool®) for post-menopausal complaints. The women used the hop-containing phytotherapeutic product (418 mg of hop per tablet) twice daily (1 and 0.5 tablets by both patient A and B). Patient A developed abdominal cramps and vaginal hemorrhage after 2 months of use. After gynecological examination, she was diagnosed with endometrial hyperplasia. The patient was treated with a curettage. The hop-containing phytotherapeutic product was discontinued, and the patient recovered. Patient B developed abdominal pain/cramps and vaginal hemorrhage after 5 months of use. A cervix smear, internal examination, and ultrasound were performed. Due to the thickness of the endometrium, a pipelle endometrial biopsy was performed. Results showed no indication for cervix cancer. The use of MenoCool® was ceased; follow-up information received from the patient shortly thereafter indicated that she had almost entirely recovered from the abdominal pain/cramps and vaginal hemorrhage. Hop (Humulus lupulus) has phytoestrogenic properties that may be the cause of endometrial hyperplasia and subsequent vaginal hemorrhage. A Naranjo assessment score of 5 was obtained for both cases, indicating a probable relationship between the patient’s endometrial proliferation and subsequent vaginal hemorrhage and their use of the suspect drug.

Details

ISSN :
21991162
Volume :
2
Issue :
1
Database :
OpenAIRE
Journal :
Drug safety - case reports
Accession number :
edsair.doi.dedup.....3529d880bc90d14e82fbe68d1464a428