FDA Approves New Option to Treat Heavy Menstrual Bleeding As
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The U.S. Food and Drug Administration granted approval to Oriahnn (an estrogen and progestin combination product consisting of elagolix, estradiol, and norethindrone acetate) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Fibroids are benign (non-cancerous) muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility. Some women may not experience any symptoms, but many do, including heavy bleeding with periods.

Although surgical treatments, such as hysterectomy, are available, patients may not qualify for surgery or want the procedure. Various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use. Approval provides an FDA-approved medical treatment option for these patients.

Women should use non-hormonal contraception during treatment and for one week after discontinuing the medication. Oriahnn may delay the detection of pregnancy because it changes menstrual bleeding patterns. Oriahnn may increase blood pressure, which should be monitored in women with controlled hypertension during treatment with Oriahnn.

Source:https://www.fda.gov/news-events/press-announcements/fda-approves-new-option-treat-heavy-menstrual-bleeding-associated-fibroids-women
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