Researchers Find Flaws In Paxil Study That Downplayed Drug’s Risk To Youth
The drug was later tied to an increase in suicidal thoughts among adolescents, according to the FDA. Elsewhere, GlaxoSmithKline's Seroxat is criticized by a medical journal for not allowing access to data it says would have shown the antidepressant is not safe or effective for youths.
The Washington Post:
Researchers: 2001 Paxil Study Seems To Play Down Suicide Risks To Youths
The study that paved the way for prescribing the antidepressant Paxil to millions of adolescents was seriously flawed, marked by what appear to be attempts to play down harms such as an increase in suicidal behavior by younger people who tested the drug, according to a reanalysis released Wednesday.(Bernstein and Cha, 9/16)
Analysis Of GSK's Seroxat Antidepressant Finds Key Data Was Held Back
A medical journal criticized British drugmaker GlaxoSmithKline on Thursday for delaying access to key data from a trial of its antidepressant Seroxat that would have shown earlier that it is neither safe or effective in adolescents. The widely used medicine, known generically as paroxetine, is linked to an increased risk of suicide in young people and has carried a Food and Drug Administration (FDA) "black box warning" advising against its use in adolescents since 2004. (Kelland, 9/16)