Three Prader-Willi syndrome organizations, working with seven clinicians who treat the condition, have issued a joint safety statement about the first drug approved to treat its hallmark hunger, after a search of the FDA's adverse event database turned up seven deaths and more than 100 reports of serious adverse events.
The statement, released August 11, 2026, concerns diazoxide choline extended-release, sold as Vykat XR. Prader-Willi Syndrome Association USA, the Foundation for Prader-Willi Research, and the International Prader-Willi Syndrome Organization said a search of the FDA Adverse Event Monitoring System reflecting reports as of July 31, 2026, found the deaths alongside more than 100 serious event reports involving edema, respiratory complications, and cardiac complications. The groups called for more careful patient selection and closer monitoring. They did not recommend against using the drug.
