Experts in Prader-Willi syndrome have issued safety alerts for Neurocrine Biosciences’ Vykat XR, citing deaths and severe adverse events reported to the FDA’s adverse event monitoring systems. The reports include seven deaths in people prescribed the drug and more than 100 serious adverse event reports, largely involving hospitalizations. The safety communication notes that the deaths and severe events have not been definitively linked to Vykat XR, but the group said the objective is to raise awareness for patients when initiating therapy. Vykat XR received FDA approval in March 2025 to address hyperphagia in children and adults with PWS. For clinicians, the key issue is whether Vykat XR’s risk profile in real-world use differs from the clinical trial dataset that supported approval. The experts’ statement increases scrutiny around monitoring and patient selection. Regulatory and pharmacovigilance follow-through—such as label updates or additional studies—will be pivotal in determining how quickly the risk signal is clarified.