Tag Archives: FDA

BNET – “Kid Overdoses in Antipsychotic Trial Caps a History of Screwups at Pfizer”

The FDA’s letter to Pfizer (PFE) describing overdoses of the antipsychotic Geodon given to 13 children in clinical trials is merely the latest in a long history of controversies that have dogged the drug at virtually every stage of its existence. Among those controversies: Discredited doctors allegedly prepared research on Geodon for the FDA; Pfizer allegedly promoted the drug for unapproved uses in kids; and the company allegedly paid a non-profit mental health advocacy group to promote Geodon for kids.

Child/Teen Suicide Rate 5 Times Higher for Kids on Antidepressants; Researchers Say findings support FDA Black Box Warnings

The heightened risk of teen suicide doesn’t vary among users of different antidepressants, a new study finds. Researchers say the finding supports the FDA’s current “black box” warning on all antidepressants detailing the increased risk of suicide attempts and suicides in children and teens who start to take the drugs. A “black box” warning is the FDA’s most severe warning label.