Pharmacovigilance Risk Assessment Committee (PRAC) recommends revoking permission to sell acetate (Ella, Esmia and other brand names), a drug used for emergency contraception and uterine myoma.

A review by the EMA Safety Committee (PRAC) confirmed that 5 mg of acetate evidence used to treat uterine myoma symptoms can cause serious liver damage, including the need for an organ transplant. PRAC therefore recommended that registration certificates for drugs based on acetate be revoked.

In its review, PRAC examined all the evidence for this, including reported cases of serious liver damage. Patients’ representatives and healthcare professionals, including gynecological experts, were also consulted. Since it is not possible to determine which category of patients are most at risk, PRAC concluded that the risk of taking this drug outweighs its benefits, and the drug should not be sold in the EU.
The use of 5 mg of acetate evidence in uterine myoma has already been suspended by EU doctors.

Acetate is also authorized as a disposable emergency contraception medicine. And the recommendation of the committee does not affect a single use of acetate and there is no fear of liver damage.

The PRAC recommendation will be sent to the European Medicines Agency (EMA) which will consider the committee’s opinion.

More about the product:

Acetate has been approved for the treatment of moderate to severe uterine myoma symptoms, which are benign uterine tumors, in women who have not reached menopause. It was used about 3 months before myoma surgery and also, with interruptions, for a long time to treat women.

Source: PIO