Tag: FDA warning

From The American Lawyer: "A federal appeals court has thrown out a $3 million verdict awarded last year to the widow of a former Reed...

The US FDA has issued a new warning for the atypical antipsychotic Olanzapine, also known by the brand names Zyprexa and Symbyax. The agency...

Yesterday, the US Food and Drug Administration (FDA) released a warning that the antipsychotic drug aripiprazole or Abilify is associated with compulsive and uncontrollable...

Writing for Forbes, Matthew Herper documents the FDA’s increasing drug approval rates. “In 2008, BioMedTracker says the FDA approved 20 new molecular entities (NMEs) and rejected 20, for an approval rate of 50%.” So far this year, he writes, “the FDA approval rate is more like 96%.”

A former Duke University psychiatry chair is calling for a retraction of a study suggesting that the FDA's black-box warnings about increased suicidality in youth taking SSRIs led to increases in adolescent suicide attempts.

A British Medical Journal study led by Harvard Medical School's Christine Lu suggested that black box warnings about increased suicidality in youth who take antidepressants actually led to increases in adolescent suicide attempts. However, the latest in a stream of critics of that conclusion are the authors of one of the key studies cited by Lu in support of her team's analysis.

A study that appeared online in the British Medical Journal suggests that the FDA’s warning in 2003 that antidepressants increase the risk of suicidal ideation in youth paradoxically  led to an increase in suicide attempts in this age group. Media reports on the study tell of how the black-box warning “backfired.” But is this conclusion warranted by the study? Or is the study flawed? And how did the media report on this story?