FDA approves new option to treat heavy menstrual bleeding associated with fibroids

FDA on Friday approved an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate (Oriahnn—AbbVie) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

FDA on Friday approved an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate (Oriahnn—AbbVie) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The benign muscle tumors of the uterus can cause heavy menstrual bleeding, pain, bowel or bladder problems, and infertility. The efficacy of Oriahnn was established in two clinical trials in which nearly 600 premenopausal women with heavy menstrual bleeding received either the drug or placebo for 6 months. The most common adverse effects of Oriahnn were hot flushes, headache, fatigue, and irregular vaginal bleeding. The drug may cause bone loss over time, and the loss in some women may not be fully recovered after discontinuing treatment. Due to the increased risk of fractures from bone loss, women should not take Oriahnn for more than 24 months. The drug's label includes a boxed warning about the risk of vascular events and thrombotic or thromboembolic disorders, particularly in women at greater risk for these events. Oriahnn is contraindicated in women with a history of or current blood clots, in women at increased risk for blood clots, those with known osteoporosis, a history of current breast cancer or other hormonally sensitive cancer, liver disease, or undiagnosed abnormal uterine bleeding. Oriahnn must also be dispensed with a patient Medication Guide that describes key information about the drug's uses and risks.