Breaking News From Congressional Hearings!!![drugawareness]

[Guest guest]

atracyphd2

Thu, 23 Sep 2004 15:47:08 EDT

 

Subject:[drugawareness] Breaking News From Congressional Hearings!!!

 

 

WONDERFUL NEWS ONCE AGAIN TODAY FROM THE CONGRESSIONAL HEARINGS THAT

RECONVENED TODAY. YOU WILL RECALL THAT THE FIRST HEARING TWO WEEKS AGO

ENDED WITH REP. BARTON TELLING THE FDA THAT IF THEY DID NOT TURN OVER

THE DOCUMENTS THAT CONGRESS HAD REPEATED REQUESTED THAT HE WOULD GO IN

WITH THE CAPITOL POLICE AND TAKE THEM!!! HERE IS THE LASTEST IN

TODAY'S HEARING THAT IS STILL ONGOING:

 

" Barton and other lawmakers criticized the agency's handling of an

investigation of the connection between widely prescribed

antidepressants and suicidal behavior in children and teens.

 

" The fact that children taking antidepressants were experiencing

psychiatric adverse events at greater rates than adults was known at

the agency as far back as 1996 and 1997, " Barton, a Texas Republican,

said at a hearing of the oversight and investigations subcommittee.

 

" I want to know: what did the agency do to respond to these concerns? "

Barton said.

 

" Recent questions about youth antidepressant use began in May 2003

when another FDA reviewer raised concerns that the drugs might

increase the chances of suicidal acts. But top agency officials did

not publicly confirm a link until last week. "

 

AND HERE THIS REPORTER GOES MAKING THAT STATEMENT AGAIN THAT IS

INFURIATING ME AS I SEE IT REPEATED OVER AND OVER

AGAIN!!!!!!!!!!!!!!!!!!! IT WAS A 200% INCREASE, NOT 2 - 3% AND I AM

NOT STOPPING UNTIL THEY GET IT STRAIGHT! THIS WAS A HUGE INCREASE IN

SUICIDE RISK, NOT AN INSIGNIFICANT INCREASE IN DEATHS.

 

" An FDA analysis estimated 2 percent to 3 percent of children and

teens who take antidepressants might have an elevated risk for

suicidal behavior. But no suicides occurred in studies of more than

4,000 children as young as six. "

 

IF ANY OF YOU SEE THIS MISTAKE MADE BY A REPORTER, PLEASE SET THEM

STRAIGHT!

 

Dr. Tracy

______________

 

Ann Blake Tracy, Ph.D.,

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio

tape on safe withdrawal: " Help! I Can't Get Off My Antidepressant! "

Order Number: 800-280-0730

Website: www.drugawareness.org

 

 

http://www.reuters.com/newsArticle.jhtml?type=healthNews & storyID=6318241

US Lawmaker Blasts FDA Over Antidepressants Risk

 

Thu Sep 23, 2004 12:52 PM ET

 

By Lisa Richwine

 

WASHINGTON (Reuters) - U.S. Food and Drug Administration staff first

questioned the possibility of a link between antidepressant use and

suicidal behavior in youth as far back as eight years ago, a senior

U.S. lawmaker charged on Thursday.

 

Rep. Joe Barton, chairman of the House Energy and Commerce Committee,

said one FDA medical reviewer raised the question of whether Pfizer

Inc.'s Zoloft had increased the risk of suicidal behavior in pediatric

clinical trials in a 1996 review.

 

Barton and other lawmakers criticized the agency's handling of an

investigation of the connection between widely prescribed

antidepressants and suicidal behavior in children and teens.

 

" The fact that children taking antidepressants were experiencing

psychiatric adverse events at greater rates than adults was known at

the agency as far back as 1996 and 1997, " Barton, a Texas Republican,

said at a hearing of the oversight and investigations subcommittee.

 

" I want to know: what did the agency do to respond to these concerns? "

Barton said.

 

Recent questions about youth antidepressant use began in May 2003 when

another FDA reviewer raised concerns that the drugs might increase the

chances of suicidal acts. But top agency officials did not publicly

confirm a link until last week.

 

Dr. Robert Temple, director of the FDA's Office of Medical Policy,

defended the agency's handling of the controversy. He said data were

unclear and officials wanted to be certain of the risks before warning

doctors and the public.

 

" The agency realizes its responsibility to the public to find the

right answer to this question, " Temple said in remarks prepared for

delivery at the hearing.

 

(snip)

 

The committee was scheduled to hear from Dr. Andrew Mosholder, the FDA

reviewer who told officials months ago he felt the drugs could make

youth suicide-prone. His supervisors disagreed and kept him from

presenting his analysis at a public advisory committee meeting in

February.

 

The FDA now is drafting new warnings for all antidepressants about the

possibility of suicidal thoughts and actions among youth who take the

drugs. A panel of outside experts has recommended the drug labels

highlight the risk in a " black box, " the strongest type of warning for

prescription drugs.

 

An FDA analysis estimated 2 percent to 3 percent of children and teens

who take antidepressants might have an elevated risk for suicidal

behavior. But no suicides occurred in studies of more than 4,000

children as young as six.

 

Antidepressants include Eli Lilly and Co.'s Prozac, Pfizer's Zoloft,

GlaxoSmithKline Plc's Paxil, Forest Laboratories Inc.'s Celexa and

Wyeth's Effexor.

Prozac also is sold under the generic name fluoxetine.

 

© Reuters 2004. .