The Spanish Agency for Medicines and Health Products (AEMPS) warns of a new side effect in fezolinetant (marketed under the name Veoza), a drug to treat hot flashes and night sweats associated with menopause.
Specifically, it warns of cases of liver damage in some patients undergoing treatment. Some of them had characteristic signs or symptoms of liver damage, such as tiredness, itchy skin, jaundice (yellowing of the skin and eyes), choluria (dark urine), lack of appetite and/or abdominal pain. Some effects on the liver had already been seen in clinical trials, so its consumption was discouraged in people with liver pathology.
For all these reasons, now, the Spanish regulatory agency, dependent on the Ministry of Health, recommends performing liver function tests before starting treatment; as well as monthly after the start of it. They should also be carried out if there are symptoms suggesting liver damage.
In case of alteration in the liver, Health recommends repeating the tests until the parameters have normalized. In case of symptoms that actually indicate liver damage, the AEMPS urges the suspension of treatment.
In this way, Spain includes the new recommendations established by the European Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).
Unlike others available on the market, fezolinetant It is a non-hormonal medication. Before menopause, there is a balance between estrogen, a female sex hormone, and a protein made by the brain known as neurokinin B (NKB), which regulates the brain’s temperature control center. With menopause, estrogen levels decrease and This balance is altered, which can cause the well-known hot flashes and sweating.. By blocking NKB binding to the temperature control center, Veoza reduces the number and intensity of these symptoms.
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