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Change Suicide Warning On Antidepressants FDA Asks Drug Makers
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Change Suicide Warning On Antidepressants FDA Asks Drug Makers
"The US Food and Drug Administration (FDA) has asked makers of all antidepressant drugs to change the existing "black box" labels on their products to warn about increased risk of suicidality (suicidal thinking and behaviour) among young adults aged 18 to 24 in the first few weeks of treatment."

" The FDA has also asked the drug companies to revise the existing warning to show there is no evidence this risk exists for adults over 24, and indeed for those aged 65 and older the scientific data suggests the suicidality risk is decreased."

" "The FDA's new labeling acknowledges, for the first time, that untreated depression puts people at risk for suicide.""

" They said studies showed that the old label issued in 2004 was associated with a steep drop in use of antidepressants and was followed by an increase in the rate of suicide "reversing a decade-long decline in suicide deaths in the United States"."

" The FDA said the emphasis on the new labels should be that depression and other serious psychiatric illnesses are themselves the most important causes of suicide."

" Director of FDA's Center for Drug Evaluation and Research, Dr Steven Galson said yesterday that:"

" "Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products.""

" "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks," he explained."

" The FDA recommends that people who are currently taking antidepressants should not stop taking them as a result of hearing this news. If you are worried about it, talk to your doctor, is their advice."

" The warning revision applies to all antidepressants and comes in the wake of controlled trials that showed a reasonably consistent risk of suicidality across most of the antidepressant drug categories. The FDA said that the evidence does not support excluding any antidepressant medication
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