Rx to Control Menstrual Bleeding Gets Green Light

FDA approves Oriahnn for heavy menstrual bleeding linked to fibroids

(RxWiki News) A medication used to treat heavy menstrual bleeding has won approval from the US Food and Drug Administration (FDA).

The FDA has approved Oriahnn to treat heavy menstrual bleeding linked to uterine fibroids in women who have not gone through menopause.

This medication is available in capsule form and consists of elagolix, estradiol and norethindrone acetate.

Fibroids are tumors in the uterus, but they are not cancerous. Fibroids can lead to heavy menstrual bleeding, pain, bowel/bladder problems and even infertility.

“Uterine fibroids are the most common benign tumors affecting premenopausal women, and one of the most common symptoms from fibroids is heavy menstrual bleeding,” said Dr. Christine P. Nguyen, acting director of the FDA's Division of Urology, Obstetrics and Gynecology, in a press release. "Various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use."

Two clinical trials established Oriahnn's efficacy in treating heavy menstrual bleeding, according to the FDA.

Commons side effects of Oriahnn included hot flushes, headaches, feeling tired and irregular vaginal bleeding. This medication also holds a boxed warning (the strongest type of drug warning) for the risk of strokes and blood clots. This is particularly a risk for women who are already at risk for strokes and blood clots.

As a result, this medication is NOT to be taken by women who have a history of blood clots or have current blood clots. Furthermore, women who are at an increased risk for blood clots (women over 35 years of age who smoke or who have uncontrolled high blood pressure) should not take this medication, the FDA noted.

Here are some other factors that could make this medication dangerous for some women:

  • Known osteoporosis
  • A history of breast cancer or current breast cancer, as well as other hormonally sensitive cancer
  • Liver disease
  • Undiagnosed abnormal uterine bleeding

This medication should not be taken for longer than 24 months because it may cause bone loss over time.

If you are allergic to FD&C Yellow No. 5 (tartrazine), let your doctor know, as this medication contains FD&C Yellow No. 5.

The approval of this medication was granted to AbbVie Inc. It is expected to hit the shelves by the end of June.