FDA panel will review drug-associated suicidality study
FDA will discuss the results of its analysis of suicidality from placebo-controlled trials of 11 drugs at a joint advisory committee meeting, which could lead to broad class labeling changes. Members of the Peripheral and Central Nervous System Drugs, Psychopharmacological Drugs, Pediatric, and Drug Safety and Risk Management Advisory Committees will meet July 10 to consider the analysis and determine whether any additional actions are necessary. Findings of increased risk of suicidality in patients taking antiepileptic drugs were noted in a MedWatch alert issued in January (1"The Pink Sheet," Feb. 4, 2008, p. 3)
You may also be interested in...
FDA findings of an increased risk of suicidality in patients given antiepileptic drugs will likely lead to broad class labeling changes, according to a MedWatch alert issued Jan. 31
As FDA decision on Alzheimer’s product approaches, new paper outlines Lilly’s arguments for unfettered Medicare coverage for donanemab once it is approved.
Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.