A physician-led group of experts in Prader-Willi syndrome notified clinicians about safety signals tied to Neurocrine Biosciences’ newly approved Vykat XR. The statement points to seven reported deaths among patients prescribed the drug and more than 100 reports of serious adverse events, largely hospitalizations for swelling and respiratory or heart complications, according to the FDA’s adverse event monitoring systems. Neurocrine’s Vykat XR was approved in March 2025 to curb intense hunger in Prader-Willi syndrome. The experts emphasized that neither the deaths nor the severe events have been definitively linked to the product, but the notice aims to increase awareness of potential risks when starting therapy. The development may affect prescribing behavior and risk-benefit discussions while regulators and sponsors assess causality, event patterns, and labeling needs.