- EU reported cases of liver injury, following which DCGI ordered state drug controllers to recall ulipristal tablets from the market.
- PRAC had recommended the suspension of sale, manufacture, and distribution of the said tablets
- Philippines, Thailand, Malaysia, Singapore, Ireland, and Dubai have already asked for a voluntary recall of the tablets.
THD NewsDesk, New Delhi: Taking cognizance of Europe’s reports of severe liver injury due to the intake of ulipristal acetate tablets, PRAC had advised against their usage. Acknowledging the Pharmacovigilance Risk Assessment Committee recommendations, the DCGI directed state drug controllers to terminate the manufacturing, sale, and distribution licenses of ulipristal tablets. As per the letter issued by the DCGI, they have been asked to recall the drug from the pharma market as well.
The letter issued by the DCGI to state drug controllers said,
“In May 2018, the 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. During the review, an additional case was reported regarding an acute liver failure associated with the use of Ulipristal acetate 5 mg. As an outcome of the review and taking all data available into consideration, the PRAC recommended measures to minimise the risk of serious liver injury associated with the ulipristal acetate 5 mg.”
Hemant Koshia Commissioner, FDCA Gujarat, said, “Following the given instructions by the DCGI, we have directed our team and initiated measures to recall and suspend the sale, manufacturing and distribution licenses of ulipristal acetate 5 mg.”
Ulipristal acetate tablets are generally helpful in treating moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Complying with EMA recommendations, the Philippines, Thailand, Malaysia, Singapore, Ireland, and Dubai have also advocated for recalling the drug.
Because the development of hepatic failure may not be mitigated even with risk minimization measures employed earlier, PRAC has suggested that the use of ulipristal acetate be suspended. The recommendations were based on a comprehensive analysis of the benefit-risk of the drug in question. Additionally, the effectiveness of the risk minimization measure attempted is also taken into account.
Source: Express Healthcare