Experts on Prader-Willi syndrome sounded the alarm over safety signals possibly linked to Neurocrine Biosciences’ Vykat XR, after reports of deaths and serious adverse events. The experts noted seven deaths and more than 100 serious event reports, including hospitalizations for swelling, respiratory, and heart complications, though they stopped short of definitively attributing causality. The safety notice follows the drug’s FDA clearance in March 2025 for hunger symptoms in PWS, and it adds scrutiny to post-approval pharmacovigilance as clinicians weigh risks when initiating therapy. The FDA-linked adverse-event information and the expert-authored communications elevate the importance of careful patient selection and monitoring during treatment initiation and dose adjustments.