FINALLY!! ADULT SSRI USE & SUICIDALITY TO GET FDA ADISORY COMMITTEE REVIEW

[Guest guest]

atracyphd2

Fri, 27 May 2005 02:42:14 EDT

[drugawareness] FINALLY!! ADULT SSRI USE & SUICIDALITY TO GET

FDA ADISORY COMMITTEE REVIEW

 

 

 

Everyone, please prepare for this meeting coming up in the next few

months.

You will finally be able to stand up for your loved ones who can no

longer do

so for themselves thanks to an SSRI cutting their lives short.

 

This review is so incredibly overdue!

 

Had the FDA advisory committee I testified before in 1991 listened to us

then, there would be no need for this meeting to take place!!! How

MANY MORE have

died so needlessly as a result of SSRI use in the interim?!!

 

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)

_________________________

 

 

Adult SSRI Use And Suicidality To Get Committee Review In Next Few

Months,

Johnson & Johnson Says

 

FDA will convene an advisory committee within the next few months to

assess the risk of suicidality in adults using selective serotonin

reuptake inhibitors, Johnson & Johnson Senior VP and Therapeutic Area

Head-Internal Medicine Joanne Waldstreicher said May 26.

 

“There is going to be an FDA advisory committee within the next few

months to review SSRIs and suicidality in adults,†Waldstreicher said

during the company’s R & D day in New York.

 

J & J submitted an NDA for its SSRI dapoxetine in December. The company

is seeking a premature ejaculation indication for the product.

 

An advisory committee meeting on SSRI use and adult suicidality would

have implications for most of the major products in the antidepressant

category, including Forest’s Lexapro, Celexa and generics;

GlaxoSmithKline’s Paxil CR and Paxil generics; Lilly’s Symbyax and

Prozac generics; Pfizer’s Zoloft; Organon’s Remeron; and generic

versions of Bristol-Myers Squibb’s Serzone.

 

The meeting also would likely impact the two approved serotonin and

norepinephrine reuptake inhibitors: Lilly’s Cymbalta and Wyeth’s

Effexor.

 

All antidepressants now carry a “black box†warning and other language

concerning the risk of pediatric suicidality.

 

FDA requested the black box class warning following a recommendation by

the agency’s Psychopharmacologic Drugs & Pediatric Advisory Committees

in September.

 

Dapoxetine’s label presumably would have to include the same black box

warning.

 

Nevertheless, J & J is attempting to differentiate dapoxetine from the

rest of the SSRI class.

 

“There are lots of SSRIs on the market but dapoxetine is different,â€

Waldstreicher said. “It has a different pharmacokinetic profile.

Dapoxetine has a fast onset of action, peaks at a little more than an

hour and is rapidly cleared. This makes the drug ideal for as-needed

dosing rather than needing to take it on a daily basis.â€

 

“This is unlike the long-acting SSRIs, which are already on the market

for other conditions like depression, where the drug hangs around for a

long period of time and accumulates,†she said.

 

In dapoxetine clinical trials there were no adverse events related to

suicide, Waldstreicher noted.

 

“In our Phase III pivotal U.S. trials in over 3,000 men we have seen no

suicide-related adverse events,†she said.

 

Dapoxetine is undergoing a standard review at FDA, with an estimated

user fee deadline of Oct. 27.

 

The company expects an advisory committee review of the dapoxetine NDA

separate from the SSRI class review on adult suicidality.

 

To arrange for a webcast of this meeting or live videoconferencing, or

to order videotapes & DVDs, email webcasthelp or call

800-627-8171.