Post-marketing safety surveillance and signal characterization of the novel dissociative steroid Vamorolone in Duchenne muscular dystrophy: a comparative disproportionality analysis based on FAERS data. (PubMed, Front Pharmacol) - Jul 12, 2026 - "To comprehensively evaluate the real-world post-marketing safety profile of the novel dissociative steroid Vamorolone and perform a comparative analysis against the traditional glucocorticoid deflazacort. Nevertheless, known risks and unexpected hypothesis-generating signals-such as notable HPA axis suppression and early-onset psychiatric disturbances-remain critical safety concerns. Clinicians should interpret these differential reporting patterns with caution and rigorously monitor neurobehavioral and adrenal health during the first three months, with further external validation warranted."
Journal • P4 data • CNS Disorders • Duchenne Muscular Dystrophy • Genetic Disorders • Infectious Disease • Mental Retardation • Muscular Dystrophy • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Psychiatry • Rheumatology • Urinary Incontinence
|
|
Hao Wu; Junguo Duan; Ruixia Wang; Xiyue Tan; Xueting Wang; Yining Zeng; Yuxia Liu
|