FDA ADVISORY: Suicidality in Adults Treated with Antidepressant Medications

[Guest guest]

atracyphd2

Fri, 1 Jul 2005 16:38:59 EDT

[drugawareness] FDA ADVISORY: Suicidality in Adults Treated

with Antidepressant Medications

 

 

 

 

After 15 years of telling them they are finally beginning to " get it " ? And

these are the people we look to for protection from dangerous drugs?!!

 

Yet today 94% of AOL readers (But you have to wonder about anyone who uses

AOL anyway right? And before you comment, notice I am with AOL.) have

voted that

they agree with Brooke Sheilds on this issue!! Sicking that I have

worked for

15 years to get this information to the public and have educated only

6% of

the public to the dangers of these drugs?!!

 

If would like to vote for Tom you can go to the following link and do so:

 

http://aolsvc.news.aol.com/movies/article.adp?id=20050701071209990018

 

 

Dr. Tracy

______________________

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition For Drug Awareness

www.drugawareness.orgÂ

Author of the " Bible on Antidepressants, " Prozac:

Panacea or Pandora? - Our Serotonin Nightmare

& audio " Help! I Can't Get Off My Antidepressant! "

(Order: 800-280-0730)

_________________________

 

 

http://www.fda.gov/cder/drug/advisory/SSRI200507.htm

 

FDA Public Health Advisory

 

Suicidality in Adults Being Treated with Antidepressant Medications

 

Several recent scientific publications suggest the possibility of an

increased risk for suicidal behavior in adults who are being treated with

antidepressant medications. Even before these reports became

available, the FDA began a

complete review of all available data to determine whether there is an

increased

risk of suicidality (suicidal thinking or behavior) in adults being

treated

with antidepressant medications. It is expected that this review will

take a

year or longer to complete. In the meantime, FDA is highlighting that:

 

Adults being treated with antidepressant medications, particularly those

being treated for depression, should be watched closely for worsening of

depression and for increased suicidal thinking or behavior. Close

watching may be

especially important early in treatment, or when the dose is changed,

either

increased or decreased.

 

Adults whose symptoms worsen while being treated with antidepressant

drugs,

including an increase in suicidal thinking or behavior, should be

evaluated by

their health care professional.

 

These recommendations are consistent with existing warnings for treated

adults in the approved labeling (package insert) for antidepressant

medications

that can be found at:

 

http://www.fda.gov/cder/drug/antidepressants/PI_template.pdf

 

The Healthcare Professional and Patient Information Sheets for the

antidepressant indications will be updated to add this information

within the week. A

list of drugs to be included in this update can be found at:

 

http://www.fda.gov/cder/drug/antidepressants/antidepressantList.htm

 

FDA is working closely with the manufacturers of all marketed

antidepressants

to fully evaluate the risk of suicidality in adults treated with these

drugs.

The FDA has asked these manufacturers to identify all placebo-controlled

trials conducted in adults in their development programs for their

antidepressant

products, regardless of the indication studied, and to provide information

from these trials to FDA. Manufacturers are being asked to use a

similar approach

to assembling this information as was used in evaluating the risk of

suicidality in placebo-controlled trials in pediatric patients treated

with

antidepressant medications. The method used to analyze the data for

risk of suicidality

in children using antidepressant medications is described in more

detail at

the following web page:

 

http://www.fda.gov/cder/drug/antidepressants/default.htm. A similar

approach

will be used for adults.

 

FDA’s comprehensive review will involve many hundreds of individual

clinical

trials and many thousands of adult patients. It is expected that this

review

will require a year or more to complete because of the large number of

trials

and the thousands of adverse events that must be checked for possible

evidence

of suicidality. The FDA will make the results of its review available

to the

public once its analyses are complete, and will update this advisory

in the

meantime if more definitive information becomes available.