Richter’s Uterine Fibroid Drug Esmya Hit By Liver Safety Concerns In EU

 
• By Ian Schofield
  
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EU safety restrictions relating to liver toxicity concerns are likely to lead to changes to the labeling of Richter’s uterine fibroid product Esmya and to a sharp drop in the product’s sales. The moves could also affect the product in the US, where it was filed for approval last year.

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Richter's Esmya is under scrutiny over reports of liver damage in the EU

Changes are likely to be made to the labeling of Gedeon Richter’s uterine fibroid drug Esmya (ulipristal acetate) as a result of the ongoing EU review of reports of hepatic injury in women taking the product. The company also predicts a sharp drop in sales of the product as a result of temporary restrictions recommended by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee earlier this month. It says that no causal relationship has yet been established between its product and liver damage.

A total of five reports of serious liver injury, including four cases of hepatic failure needing liver transplantation, have now...

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