J&J Concerta, Methylphenidate Adverse Events Not New Signal, Committee Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's pediatric committee is hesitant to recommend a labeling change for attention deficit/hyperactivity disorder drugs based on current data. FDA should, however, communicate concerns about psychiatric events to the public, possibly through Drug Watch website.
You may also be interested in...
Sparlon Shows 31 Cases Of Suicidality, Aggression or Psychosis In ADHD Database
Incidence of events with Sparlon is higher than for placebo but exposure in patients is also greater, FDA summary of clinical adverse events states.
Sparlon Shows 31 Cases Of Suicidality, Aggression or Psychosis In ADHD Database
Incidence of events with Sparlon is higher than for placebo but exposure in patients is also greater, FDA summary of clinical adverse events states.
Cardiac, Neuropsychiatric Events With ADHD Drugs To Be Discussed By Pediatric Committee
FDA's Pediatric Advisory Committee will address neuropsychiatric and cardiovascular events possibly related to attention deficit/hyperactivity disorder medications at a March 22 meeting