FDA says adults on anti-depressants must be closely watched!!

[Guest guest]

Oh my gosh, check this out!!!!

Source of info:

http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01362.html

 

What a laugh, their a bunch of idiots!!!!

 

FDA Talk Paper

 

T05-25

July 1, 2005

 

 

Media Inquiries:

Laura Alvey, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

 

FDA Reviews Data for Antidepressant Use in Adults

 

In response to recent scientific publications that

report the possibility of increased risk of suicidal

behavior in adults treated with antidepressants, the

U.S. Food and Drug Administration (FDA) has issued a

Public Health Advisory (PHA) to update patients and

healthcare providers with the latest information on

this subject.

 

Even before the publication of these recent reports,

FDA had already begun the process of reviewing

available data to determine whether there is an

increased risk of suicidal behavior in adults taking

antidepressants. The Agency has asked manufacturers to

provide information from their trials using an

approach similar to that used in the evaluation of the

risk of suicidal behavior in the pediatric population

taking antidepressants. This effort will involve

hundreds of clinical trials and may take more than a

year to complete.

 

In the meantime, the PHA advises health care providers

and patients to be aware of the following:

 

* Adults being treated with antidepressant

medicines, particularly those being treated for

depression, should be watched closely for worsening of

depression and for increased suicidal thinking or

behavior.

* Close observation of adults may be especially

important when antidepressant medications are started

for the first time or when doses for the specific

drugs prescribed have been changed.

* Adults whose symptoms worsen while being treated

with antidepressants, including an increase in

suicidal thinking or behavior, should be evaluated by

their health care professional.

 

These recommendations are consistent with warnings

already present in approved labeling for

antidepressants used by adults.

 

FDA will provide updated information as it becomes

available. The Public Health Advisory is available on

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