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

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

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 and label 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.

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

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

In May 2018, Pharmacovigilance Risk Assessment Committee (PRAC) in EMA finalised 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 minimisation measures implemented previously. 

In light of the report of serious liver injury initially, EMA recommended suspension of the ulipristal tablets 5mg. Subsequently, however, based on recommendation of the Committee for Medicinal Products for Human Use (CHMP), the EMA has recommended restricted use of ulipristal tablets 5mg.

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