EU Regulators to Review Fibroid Drug for Possible Liver Risk

Disclosures

December 01, 2017

European Union (EU) regulators have started to investigate whether a drug that treats uterine fibroid symptoms called ulipristal acetate (Esmya, Gedeon Richter) may injure the liver.

Sparking the investigation were four reports of serious liver damage in patients treated with ulipristal acetate, three of whom required liver transplants, according to a news release issued today by the European Medicines Agency (EMA).

In the United States, ulipristal acetate is not approved to treat fibroid symptoms, such as bleeding, anemia, and abdominal pain, although Allergan announced in October that it has asked the US Food and Drug Administration (FDA) to greenlight this indication.

Ulipristal acetate also is the active ingredient in the emergency contraceptive Ella  (Afaxys Pharma), which the FDA approved in 2010. Clinicians have used Ella on an off-label basis to treat uterine fibroid symptoms.

In the EU, ulipristal acetate for emergency contraception goes by the name of ellaOne (HRA Pharma). The EMA said that it has not come across any cases of serious liver injury associated with ellaOne, adding, "There are no concerns with the medicine at this time."

Esmya is indicated In the EU to treat moderate to severe symptoms of uterine fibroids in women who have not reached menopause. Women scheduled for surgery to remove fibroids are sometimes prescribed the drug up to 3 months in advance to reduce symptoms, as well as shrink the tumor. Women also can use Esmya on a long-term basis, taking the once-a-day pill for 3-month stretches, with breaks in between.

The EMA estimates that some 670,000 women have taken Esmya.

Ulipristal acetate works by blocking the action of the hormone progesterone in controlling the growth of the endometrium. Progesterone may stimulate the growth of fibroids, so by preventing the hormone's effects, the drug reduces the size of fibroids as well as their symptoms, the EMA said.

The EMA's Pharmacovigilance Risk Assessment Committee will investigate whether there is a causal link between Esmya and liver damage.

More information on today's announcement by the EMA is available on the agency's website.

Follow Robert Lowes on Twitter @LowesRobert

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