It has confirmed that “Esmya 5 mg in tablets, a drug used to treat uterine fibroids that was withdrawn for causing liver damage, returns to the market after being authorized again, although this drug will only be used in cases where there is no other treatment option”.
“Esmya (ulipristal acetate) is a medicine used for the treatment of uterine fibroids. Since 2018 it has been under close surveillance by the European Medicines Agency (EMA) due to the occurrence of very rare but serious cases of liver damage. A few years ago we echoed this risk, which in some cases forced those affected to perform liver transplants. In March 2020, after the appearance of a new case of liver failure that required a liver transplant, the European Medicines Agency recommended the suspension of the marketing of this medicine, while a new evaluation of the risk/benefit balance of Esmya”.
As they say from the OCU, the drug has returned to sale, but with several restrictions. “Following the studies carried out, the European authority has finally recommended authorizing the marketing of this medicine again, but only for cases where there is no other treatment option.
In any case, the Organization of Consumers and Users affirms all the and precautions for the use of this medicine in relation to possible liver damage remain.
Women who are prescribed this medication should note that:
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They are needed blood test before, during and after treatment to monitor liver function.
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They must be vigilant for the appearance of signs or symptoms that may indicate the presence of liver problems: pain in the upper right part of the abdomen, nausea, vomiting, lack of appetite, yellowing of the skin or the white part of the eyes, dark urine, white or colorless stools. And if so go to the doctor as soon as possible.