title: Post-Menopausal Vaginal Hemorrhage Related to the Use of a Hop-Containing Phytotherapeutic Product.
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.
authors.affiliation: Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's Hertogenbosch, The Netherlands. f.vanhunsel@lareb.nl.
authors.forename: Florence
authors.initials: F
authors.lastname: van Hunsel
authors.affiliation: Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's Hertogenbosch, The Netherlands.
authors.forename: Sonja
authors.initials: S
authors.lastname: van de Koppel
authors.affiliation: Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's Hertogenbosch, The Netherlands.|Department of Pharmacy, Pharmacotherapy and Pharmaceutical Care, University of Groningen, Groningen, The Netherlands.
authors.forename: Eugène
authors.initials: E
authors.lastname: van Puijenbroek