antidepressants in pediatric population

[mskris]

All:

Just wanted to let you know that the FDA advisory committee conference on antidepressant use in pediatric population/suicidal ideation concluded there is a statistically significant link between these two. The committee voted 25 to one with one abstention that reanalysis of the data demonstrates a causal relationship between 9 antidepressants and suicidality.

They recommended a warning on labels of selective serotonin reuptake inhibitors (SSRIs) about the risk of suicidal ideation among children prescribed these medicines (paxil, zoloft, celexa, prozac, effexor, wellbutrin, remeron, serzone, and luvox). Only prozac has shown evidence of efficacy in pediatric patients.

From the "Pink Sheet":
"Committee members seemed particularly influenced by accounts during the public hearing about patients who committed suicide while being treated for obsessive/compulsive disorder, generalized anxiety disorder, insomnia or migraine with antidepressants....The appearance of suicidal behavior and suicidal ideation in the OCD clinical trials suggests that this isn't strictly a worsening of depression or ineffectiveness in treating depression, especially since in a number of cases it seems to happen so early."

Anitdepressants already carry a class warning about the need to monitor for suicidality, but the conclusion is that the risk information needs to be elevated to bolder warning or a "black box."

They're concerned about at 2% to 3% increase of risk of suicidality, compared to a 15% risk of suicide if the underlying disease (depression) is left untreated.

Thus, to all of you who use these, or whose children do, please read all warning information and patient package insert information. Look into alternatives, if possible, and monitor the patients closely!!!

Kris

[mskris]

All:

Just FYI:

This info came from the Pink Sheet, a publication for the pharmaceutical industry from FDC Reports, a very well-respected publisher.

Please do not panic if your child is taking one of these meds. Contact your healthcare professional before making any changes to dose or medication. DO NOT stop the medications without first contacting your child's physician, as there can be risks in stopping these meds abruptly!!

Finally, these medications have helped thousands of children, although only prozac has been studied and approved for use in children. The docs are writing scrips "off-label" for the others, which is legal, but is not sanctioned by the FDA or the pharma industry. A "black box" warning is the most serious type, and, contrary to many news broadcasts, this has not been decided as yet. However, I thought you all should know the outcome of the advisory committee meeting. www.thepinksheet.com

Kris

[rosyred45]

Thanks for thinking of us Kris, we appreciate that and know that you don't want to cause alarm, just precaution.

Thanks again