GlaxoSmithKline is notifying healthcare professionals about new warnings on the risk of suicidality with Paxil (paroxetine) and Paxil CR. These labeling changes relate to adult patients, especially...
GlaxoSmithKline is notifying healthcare professionals about new warnings on the risk of suicidality with Paxil (paroxetine) and Paxil CR. These labeling changes relate to adult patients, especially young adults, ages 18 to 24.
The company recently conducted a meta-analysis of clinical trials in adult patients taking paroxetine that looked at suicidal behavior and ideation. These patients had a variety of psychiatric disorders, including Major Depressive Disorder (MDD), other depression, and non-depressive disorders such as obsessive-compulsive disorder.
This analysis showed a higher overall frequency -- two in a hundred versus one in a hundred -- of suicidal behavior in young adults aged 18 to 24 treated with Paxil compared with placebo. This was not observed in older adults.
For adults with MDD, the frequency of suicidal behavior was higher for patients of all ages treated with paroxetine compared with placebo -- about 30 in 10,000 versus 5 in 10,000. However, the majority of suicide attempts in these patients were in those aged 18 to 30. This suggests that the higher frequency of suicidality seen in younger patients across psychiatric disorders may extend beyond the age of 24.
As a result of these findings, the company says that it is important that all patients, especially young adults, be carefully monitored during paroxetine therapy regardless of the condition being treated.
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