Antidepressants come under FDA review again

pharmafile | July 4, 2005 | News story | Sales and Marketing  

The FDA is conducting another review of antidepressants to determine whether the drugs increase the risk of suicidal behaviour in adults.

It has asked manufacturers of the widely prescribed drugs to provide clinical trial data which it will assess for instances of suicidal behaviour.

The US regulator recently carried out a similar review on antidepressant use in children and concluded that some antidepressants increased the risk of suicidal thoughts in this particular group.

Its findings prompted the strongest possible label warnings (black box warning) on antidepressants in the US, with typical antidepressants like GlaxoSmithKline's Wellbutrin and Wyeth's Efexor and selective serotonin reuptake inhibitors (SSRIs) like Pfizer's Zoloft required to conform to the new labelling.

The FDA said its latest review follows reports in scientific publications of the possibility of increased risk of suicidal behaviour in adults treated with antidepressants.

It expects the review to take over a year to complete, owing to the raft of data needed to be scrutinised.

In light of the review, doctors have been reminded that patients need to be watched closely for signs of worsening depression and for increased suicidal thinking or behaviour.

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