Fezolinetant for VMS: a balanced view on efficacy and safety needed – author's reply.

This document is a reply to comments made on a previous article about the use of fezolinetant for treating vasomotor symptoms associated with menopause. The US Food and Drug Administration (FDA) investigated the potential increased risk of neoplasms (abnormal growth of tissue) with fezolinetant and found that while there was an apparent dose-response for malignancy, there were no consistent patterns related to drug exposure duration, body system, or cancer type. The authors of the reply acknowledge the increased incidence of neoplasms in patients treated with fezolinetant, but they argue that comparing the data between the fezolinetant and placebo groups with unequal follow-up durations may lead to skewed conclusions. They recommend additional long-term safety studies and close monitoring of patients using fezolinetant to make better-informed decisions about managing menopause symptoms. [Extracted from the article]