Vykat XR Postmarket Safety Signal – 7 Deaths in Prader-Willi Syndrome

Major post-market safety signal for Vykat XR (Neurocrine), first PWS hyperphagia drug. Seven deaths and >100 serious AEs reported to FAERS, mostly cardiorespiratory. Mechanism explains edema as on-target effect. No FDA action yet. Critical emerging risk for a vulnerable population.