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SSRI-Crusaders

10 Oct 2004 17:12:06 -0000

[sSRI-Crusaders] File - URGENT APPEAL

 

On Thursday, June 19, 2003, the FDA, following the lead

last week of the British MCA, ruled that Paxil should

not be given to kids 18 or under, because of the increased

risk of suicidal impulses. There are several news stories on the Internet, but the

most reliable source of information is on the official

website, www.fda.gov You can follow the links on that

website to the story about their action, and then to

their Q & A's and "contact us" feedback form.Our main concern about the FDA's action, and particularly

about their Q & A's, is two-fold: (a) instead of acknowledging the wealth of information

that indicates that this phenomenon affects adults as

well as children, they specifically say that it does not

-- people will die because of that advice; (b) they focus only on Paxil. The truth is that this is

an SSRI class-wide phenomenon. For example, if the FDA

would only look at the data in Pfizer's May 1996 submission

to them on suicidality regarding children and adolescents

in the Zoloft clinical trials, they would see (I) that the suicidality data between Zoloft and placebo in that report

was at least as damning as the newly revealed Paxil data,

and (ii) that, although they tried to lay the blame for

7 of the 8 suicidal acts off on other "stressors", even

Pfizer ADMITTED that Zoloft triggered the self-mutilation

and suicide attempt of 8 year old "patient #4".Hopefully, with public and regulatory attention now focused

on the problem, the FDA will pay attention to REAL human

stories from real people. WHAT YOU NEED TO DOPlease go to the FDA website, again at http://www.fda.gov

to follow the links to their action about Paxil and 18 year

olds, and to click the "contact us" button and then report

the factual details of your family's tragedy. Keep it short

and simple. "My husband got Paxil or Prozac or Zoloft from a GP

for ____. Seventeen days later, he hanged himself in

our back yard. He was never previously suicidal and

this action was TOTALLY out of character." It is important in this regard that the FDA see how well

your story fits the pattern of SSRI induced violence/suicide

which Lilly recognized way back in 1990-91. Specifically,

the phenomenon has four distinctive attributes: (i) the

suicidality or violence came up suddenly, almost out of the

blue, (ii) it was violent, (iii) there was an obsessive or

impulse nature to the patient's actions, and (iv) it was

out of character (they used the word "egodystonic").

Make your report to them with those elements in mind.A copy of this email report could/should also be shared

with the Senator Schumer's office in NY

http://schumer.senate.gov/webform.html and with the

client's senators and congressmen. Also, please forward

a copy of same to Mr. Andy Vickery, an attorney who has

been successful in litigating a number of these cases, at andyA WORD OF CAUTION.Families who have settled their legal claims have

continuing confidentiality obligations. These do NOT

preclude them from sharing the particulars of their

tragedies with the FDA or members of Congress, or,

indeed, if you choose, with members of the media

(contact us and we will give you email address of

appropriate media representative). However, NO MENTION

should be made of a settled legal claim or lawsuit.

IF you have a suit that is currently pending, you might

mention the lawsuit but refer any inquiries about the

case to your attorney. Finally, if an attorney is

representing you but the case is still in an investigative

stage, i.e. the claim has not been settled and no suit has yet been filed, then NO MENTION should be made of any legal

claim or action.========

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