FDA Statement on Recommendations of Psychopharmacologic Drugs and Pediatric Advisory Committees

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" FDA Statement on Recommendations of the

Psychopharmacologic Drugs and Pediatric

Advisory Committees "

 

http://www.fda.gov/bbs/topics/news/2004/NEW01116.html

 

The Food and Drug Administration (FDA) generally supports the

recommendations that were recently made to the agency by the

Psychopharmacologic Drugs and Pediatric Advisory Committees regarding

reports of an increased risk of suicidality (suicidal thoughts and

actions) associated with the use of certain antidepressants in pediatric

patients. FDA has begun working expeditiously to adopt new labeling to

enhance the warnings associated with the use of antidepressants and to

bolster the information provided to patients when these drugs are

dispensed.

 

In summary, the members of the advisory committees:

 

a.. endorsed FDA's approach to classifying and analyzing the suicidal

events and behaviors observed in controlled clinical trials and expressed

their view that the new analyses increased their confidence in the

results;

 

b.. concluded that the finding of an increased risk of suicidality in

pediatric patients applied to all the drugs studied (Prozac, Zoloft,

Remeron, Paxil, Effexor, Celexa Wellbutrin, Luvox and Serzone) in

controlled clinical trials;

 

c.. recommended that any warning related to an increased risk of

suicidality in pediatric patients should be applied to all antidepressant

drugs, including those that have not been studied in controlled clinical

trials in pediatric patients, since the available data are not adequate

to exclude any single medication from an increased risk;

 

d.. reached a split decision (15-yes, 8-no) regarding recommending a

" black-box " warning related to an increased risk for suicidality in

pediatric patients for all antidepressant drugs;

 

e.. endorsed a patient information sheet ( " Medication Guide " ) for this

class of drugs to be provided to the patient or their caregiver with

every prescription;

 

f.. recommended that the products not be contraindicated in this

country because the Committees thought access to these therapies was

important for those who could benefit; and

 

g.. recommended that the results of controlled pediatric trials of

depression be included in the labeling for antidepressant drugs.

 

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