Case reports submitted to the FDA describe seven deaths and nearly 100 hospitalizations among people with Prader-Willi syndrome who were prescribed Vykat XR, STAT reported on October 13. STAT obtained the records through the Freedom of Information Act. They cover the roughly 18 months since the drug was approved.
The reports do not prove that Vykat XR caused the deaths or hospitalizations. Many of the cases involved patients with complex medical problems who were taking several medications, STAT reported.
