Suspected serious side effects Warning Esmya!

Drug for uterine proliferations: No more patients on Esmya set

Esmya is a drug used to treat moderate to severe symptoms of uterine fibroids, ie benign growths of the uterus. However, the remedy should no longer be prescribed to new patients. According to experts, there is a suspicion that the drug can damage the liver.

Risk of drug for growths of the uterus

Esmya® (active ingredient ulipristal acetate) is a drug approved since 2012 for the treatment of moderate to severe symptoms of uterine fibroids, that is non-cancerous (benign) growths of the uterus. But now there is evidence that the drug can damage the liver. Even cases of liver failure have been reported. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is therefore currently undertaking a new risk assessment of the drug. Until this is completed, no new patients should be stopped on this medicine.

As a new risk assessment of the drug Esmya is currently being carried out, no new patients should be placed on the drug for the time being. There are indications that the medicine can damage the liver. (Image: megaflopp / fotolia.com)

Reports of severe liver damage

As reported by the Federal Institute for Drugs and Medical Devices (BfArM), the Pharmacovigilance Risk Assessment Committee (PRAC) is currently assessing Esmya's benefit-risk balance based on reports of severe liver damage, including cases of liver failure leading to liver transplantation.

As part of its ongoing risk assessment, the PRAC recommends regular liver tests for women receiving the drug for the treatment of uterine fibroids as an interim measure.

Patients treated with Esmya should undergo liver function tests at least once a month.

Should the test result in abnormal liver values ​​(more than double the "normal" upper limit), doctors should stop treatment with Esmya and closely monitor liver function.

The liver tests should be repeated two to four weeks after the end of treatment.

In addition, the PRAC does not recommend hiring new patients on Esmya until further notice. And patients who have completed an interval should not start another interval.

For symptoms quickly to the doctor

These recommendations are considered interim measures to ensure patient safety until the decision on the risk assessment process initiated in December 2017.

The BfArM advises patients to have blood tests performed by the attending physician to check if the liver function is in order. If the liver tests are conspicuous, the therapy with Esmya is terminated.

In addition, if symptoms such as nausea and vomiting, upper abdominal pain, loss of appetite, tiredness or yellowing of the eyes or the skin should be contacted immediately, as these symptoms may indicate liver problems.

"If you are scheduled to have Esmya therapy or a new interval, your doctor will suspend your therapy until the assessment by the EMA is complete," the BfArM informs patients.

And, "When your treatment with Esmya is over, your doctor will check your liver function for two to four weeks after the end of treatment." (Ad)