Ulipristal Acetate: A New Fibroid Treatment?

I understand there’s a new drug called ulipristal acetate, available for treating uterine fibroids. Can you tell me anything about it?

– March 8, 2018

Uterine fibroids are benign growths that are typically discovered during a routine pelvic exam or prenatal ultrasound. About 50 percent of all Caucasian women and 72 percent of all African American women develop them. Most of these growths cause no symptoms and require no treatment. Others, however, cause pelvic pain or pressure and heavy menstrual bleeding, sometimes leading to iron-deficiency anemia.

As you may know, treatment for symptomatic fibroids usually is a hysterectomy or alternatively, a myomectomy – surgery in which the growths are removed leaving the uterus intact. With the latter procedure, meant for women who desire to have children, the fibroids can grow back.

The drug you may have heard about is ulipristal acetate. Reportedly, it can stem the bleeding fibroids can cause and shrink the growths themselves, at least temporarily. Ulipristal acetate is available in Canada and Europe and may become available in the U.S. in 2018 if the U.S. Food and Drug Administration (FDA) approves it.

The medication is said to work by blocking the hormone progesterone from promoting fibroids and their symptoms. In one study, fibroids shrank to half their size among 50 percent of the women participating. According to the manufacturer, the drug can reduce bleeding within five to six days after a woman begins taking it. The recommendation is to take it for three months, then stop for a month before resuming for another three months. The break between the two cycles is designed to allow shedding of the endometrium, the lining of the uterus, which thickens in response to the drug.

Side effects, which are said to affect less than one in 10 women, may include acne, constipation, fatigue, hair loss, headache, hot flashes, nausea, obesity, and dizziness. Less often, the drug can cause more serious side effects, including abnormal uterine bleeding, breast pain or discomfort, new fibroids, ovarian cysts, and pelvic pain.

Ulipristal acetate was originally intended to help women postpone surgery for symptomatic fibroids. Since fibroids shrink (and often disappear) with menopause, taking the drug may enable older women to avoid surgery altogether.

Several other drugs can shrink fibroids but won’t eliminate them and can cause many unpleasant side effects. One type, Gn-RH agonists (Lupron, Synarel), temporarily turns off the menstrual cycle. As a result, estrogen levels fall, causing fibroids to shrink by as much as half. However, when you stop taking these drugs, the tumors usually re-grow. Side effects include hot flashes, breast tenderness and decreased sexual desire. Other drugs, similar to testosterone, can shrink fibroids, but also cause numerous side effects: weight gain, unwanted hair growth, acne, headaches, depression and anxiety.

Reportedly, at least two other drugs for fibroid treatment are in development. If ulipristal acetate becomes available here, its cost and any insurance coverage remain to be determined. In Canada the cost is about $9 per pill.

Andrew Weil, M.D.



Jacques Donnez et al, “Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids.” Fertility and Sterility, February 2015, doi.org/10.1016/j.fertnstert.2014.10.038

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