Menopause, possible liver problems with a new drug against hot flashes

Tfemale kings out of four during menopause they suffer from annoying, uncontrollable, often highly conditioning symptoms. So much so that it can compromise the quality of life over the age of 50. The most common symptom is hot flasheslasting a few seconds or several minutes, and which can begin to appear a few years before entering menopause. We talked about it here and told how in addition to hormone replacement therapy a new class of drugs was recently available, based on fezolinetantwhich expanded the possibilities in the management of disorders related to menopause, allowing therapy to be personalized based on the type and severity of symptoms.

Now AIFA, the Italian medicines agency, has published a note on its website in which it reports the possible onset of some «serious liver problems» precisely for the use of a drug based on fezolinetant, Veoza. The agency indicates that it is necessary to perform liver function tests before treatment And repeat them once a month during the first three months and then based on the doctor’s judgment. The note states that treatment with fezolinetant should not be initiated if serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels are ≥ 2x ULN or whether total bilirubin levels are ≥ 2x ULN.

These tests must also be performed when symptoms suggestive of liver damage occur and treatment with fezolinetant should be discontinued if transaminases, total bilirubin are abnormal, or if patients develop symptoms of liver injury. «Patients should be advised to watch for signs or symptoms which could be indicative of liver damage such as tiredness, itching, jaundice, dark urine, light stools, nausea, vomiting, reduced appetite and/or abdominal pain and to consult your doctor immediately if they occur” indicates AIFA. Since the drug is indicated in healthy women«the risk of serious liver damage may significantly influence its benefit/risk balance. Consequently, exposure to Veoza should be avoided in women at increased risk of liver damage and early identification of potential liver damage is essential.”

The drug in question, as mentioned, contains fezolinetant, a neurokinin 3 receptor antagonist. It is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. The safety information recently identified regarding liver damage has therefore led the European Medicines Agency, and consequently AIFA, to proceed with a review of European data in relation to the potential for fezolinetant to cause drug-induced liver injury. Information from all available sources was taken into account, including reports of adverse drug reactions and studies published in the scientific literature. Elevations in serum ALT and AST have previously been observed in clinical trials with fezolinetant and are reported in the product information.

«After they were placed on the market, they were reported severe cases of increased ALT and/or AST levels (> 10 x ULN) with concomitant increase in bilirubin and/or alkaline phosphatase (ALP). In some cases, elevated LFT values ​​were associated with signs and symptoms indicative of liver damage such as tiredness, itching, jaundice, dark urine, reduced appetite and/or abdominal pain.” Elevated liver function test values ​​and symptoms suggestive of liver injury were generally reversible after stopping therapy.

Source: Vanity Fair

You may also like