Five European women, including two French women, who were taking ESMYA, a drug prescribed for uterine fibroids, developed severe fulminant hepatitis. One of them died. The European Medicines Agency (EMA) has placed the medicine under close surveillance.
Five cases of drug-causing fulminant hepatitis (resulting in destruction of the liver) have been reported in European Medicines Agency (EMA) in women treated for uterine fibroma with ESMYA. Four of them had to undergo an emergency liver transplant to survive, but one death occurred during the transplant due to infection. Ua European-wide survey is in progress.
Prescribed for over 700,000 women worldwide
ESMYA, or ulipristal acetate, is an “orally active, selective synthetic progesterone receptor modulator”. Clearly, it is a modulator of the activity of sex hormones on the uterus. By blocking their action with a 3-month treatment, ESMYA regresses abnormalities in the endometrial tissue (“adenomyomas”) which are increased by natural sex hormones.
This drug had been the subject of serious evaluations in clinical studies involving more than 7000 women and these serious side effects had not been reported in these studies. ESMYA was a significant advance in the treatment of uterine fibroids compared to traditionally used drugs, progestins, and it has been prescribed to over 700,000 women worldwide and over 64,000 in France.
Potentially toxic to the liver
ESMYA belongs to a family of drugs which may be toxic to the liver. Moreover, the leaflet for this medication emphasizes the precautions to be taken in the event of a history of liver disease.
The responsibility of the drug is not completely proven for at least 2 of the serious cases since the liver of patients transplanted in France could be analyzed and there was a disease of the liver even before taking ESMYA.
This does not mean, however, that the drug did not make matters worse. The other severe cases are less documented, but the German patient who died was not taking any other medication.
The recommendations of the European Medicines Agency
The various analyzes still do not fully explain this severe toxicity for the liver according to Dr Pierre Demolis, head of the European Strategy Steering Center at ANSM, interviewed by our colleagues from the Figaro. According to him, it occurs without a real triggering circumstance and “does not appear to be related to an effect related to the dose or the duration of treatment”.
The European Medicines Agency recommends that gynecologists not start new treatments with ESMYA. Women currently on ESMYA will need additional tests if they have a history of liver disease. In the absence of an anomaly in the balance sheet, the treatments undertaken can be continued. The ANSM has made available a letter for doctors on his site.
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