The Directorate of Food and Drug Administration (FDA), Goa, has issued a notice for the revocation of the suspension of the manufacture, sale, and distribution of ulipristal tablets, 5 mg, based on the directive of the Drugs Controller General of India (DCGI).

This will allow the manufacture and marketing of ulipristal acetate tablets (5 mg) under restricted use, subject to the condition that the drug can only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolization) are not appropriate or have not worked.

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Ulipristal acetate is a progesterone receptor modulator used in emergency contraception.

The DCGI directive says that the drug must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment.

The warning should be included in educational materials for doctors, package insert,s and labels that this drug has been associated with irreversible liver damage even leading to death. Caution must be used when this drug is prescribed.

Liver Function Test (LFT) should be done prior to prescribing this drug. There should be every 15 days monitoring of the LFT and drugs should be stopped in case of elevated LFT.

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The drug was approved by the DCGI on March 14, 2018, for the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

The DCGI has cited European Medicines Agency (EMA) recommendations that the medicine must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment.

The manufacturing and marketing of ulipristal acetate tablets, 5 mg, for restricted use have been recommended by the EMA based on an indication that the medicine can only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolization) are not appropriate or have not worked.

In May 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) in the EMA finalized a review of the benefit-risk balance of ulipristal tablets, 5 mg, initiated due to three cases of liver injury leading to liver transplantation.

The PRAC reviewed the new cases of serious liver injury leading to liver transplantation reported with ulipristal acetate 5 mg) and concluded a probable causal association with the drug.The PRAC also noted that a progression in the development of hepatic failure leading to liver transplantation could not be prevented despite the risk minimization measures implemented previously. 

Because of the initial report of serious liver injury, the EMA initially recommended that the Ulipristal 5 mg tablets be suspended.

Subsequently, however, based on the recommendation of the Committee for Medicinal Products for Human Use (CHMP), the EMA has recommended the restricted use of ulipristal tablets 5mg.

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