DCGI Bans Manufacturing, Sale, Distribution Of Ulipristal Acetate Tablets 5 Mg

Mumbai : The Drugs Controller General of India (DCGI) has directed the state licensing authorities (SLAs) to direct manufacturers to suspend the manufacturing, sale or distribution of ulipristal acetate tablets 5 mg based on the recommendation of European Medicines Agency (EMA).

SLAs have also been directed to recall the stock in respect of the subject product from the market. The action taken in the matter may be communicated to this directorate at the earliest, as per DCGI directive.

Ulipristal acetate (Fibristal) (5 mg tablets) has been widely used for treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery.

There are reports from EMA regarding liver failure associated with the use of ulipristal acetate tablets 5 mg.

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.

Meanwhile, health activists have also urged state FDAs to urgently follow DCGI directive to suspend the manufacturing, sale, distribution of ulipristal acetate. All Food and Drug License Holders Foundation (AFDLHF) president Abhay Pandey has also reported the matter to Maharashtra Food and Drug Administration (FDA) in the interest of patient safety.

DCGI directive is also based in the light of a report of serious liver injury in European Union (EU) and recommendation of PRAC in EMA for suspension of ulipristal tablets 5 mg until a definitive conclusion is arrived.

Esmya tablet 5 mg (ulipristal acetate) has also been directed to be voluntarily recalled in Philippines, Thailand, Malaysia, Singapore, Ireland and Dubai.

The drug was approved by 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 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.

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