Neurocrine's Prader-Willi drug Vykat XR linked to multiple deaths and serious side effects

A group of physicians and experts in Prader-Willi syndrome warned clinicians about safety concerns with Vykat XR, a drug approved by the FDA in March 2025 to reduce the intense hunger in patients with the rare disorder.

Since its approval, the FDA’s Adverse Event Monitoring System has recorded seven deaths among patients taking Vykat XR, and more than 100 reports of serious adverse events have been submitted.

The reports have prompted heightened scrutiny of the drug’s safety profile, and clinicians are being advised to monitor patients closely and consider alternative management strategies while regulatory authorities review the data.