Sparlon Shows 31 Cases Of Suicidality, Aggression or Psychosis In ADHD Database
This article was originally published in The Pink Sheet Daily
Executive Summary
Incidence of events with Sparlon is higher than for placebo but exposure in patients is also greater, FDA summary of clinical adverse events states.
You may also be interested in...
Sparlon Risk Management Plan For Serious Skin Reactions To Be Discussed By Committee
During review, FDA staff disagrees about significance and implications of serious skin reactions and other adverse events with Sparlon.
Sparlon Risk Management Plan For Serious Skin Reactions To Be Discussed By Committee
During review, FDA staff disagrees about significance and implications of serious skin reactions and other adverse events with Sparlon.
Meridia Pediatric Adverse Events Will Get Continued Monitoring
FDA notes that only one pediatric adverse case report was recorded and additional surveillance is necessary for a more meaningful analysis.