FDA and EMA do not warn: Leberschäden under Fezolinetant

I am 12. September 2024, the FDA issued a first safety warning for the Einnahme von Fezolinetant aus. A post-marketing message has appeared that has resulted in a number of claims after about 40 messages about a message. The patient has significant hypertension, may have one of elevated alanine aminotransferase (ALT), triple bilirubin levels, and quadruple alkaline phosphatase (AP). Be sure to experience fatigue, nausea, nausea, vomiting of the abdomen and head, light stuhling and thin urine – typical features of a liver function disorder. After the absence of fezolinetant, the clinical picture and the clinical symptom normalize. Am December 16, 2024, the FDA changed the warning to a “Boxed Warning” in the product information (1). Der Warnhinweis enthält follows Angaben:

• Before starting therapy with fezoline therapy, it is best to undergo treatment (the transaminases ALT and AST, the alkaline phosphatase AP, bilirubin). Lie de ALT, AST und Bilirubinwerte über dem Zweifachen Normwert, sollte keine Therapie ergolgen.
• Life will probably lead to the first three therapy sessions, then a new monaten can become best.
• Symptom of a problem with fatigue, fatigue, appetite, erbrechen, juckreiz or der gelbfärbung, so that eating is not interrupted and information is informed.
• At Transaminasewerten (ALT, AST), the functional norms and transaminasewerten over the three-phase norms plus an increase in the Bilirubinewerten over the zweifachen Normwert that will be carried out.
• If the Transaminases (ALT, AST) exceed the normal values, it is best that this is done, no matter how normal it is (2).