Suicide warning issued for young Paxil users (AP/CNN) {drug side effect}

[eppur_se_muova]

Friday, May 12, 2006; Posted: 5:40 p.m. EDT (21:40 GMT)

WASHINGTON (AP) -- The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration warned Friday in a letter to doctors.

The warning letter was accompanied by changes to the labeling of both Paxil and Paxil CR, a controlled-release version of the drug, also called paroxetine.

A recent analysis of clinical trial data on nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the letter.

The FDA reported that there were 11 suicide attempts -- none resulting in death -- among the patients who received Paxil in the trials. Just one of the dummy pill patients attempted suicide.

Given that small number, the results "should be interpreted with caution," the FDA said. Eight of the 11 attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.
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more: http://www.cnn.com/2006/HEALTH/05/12/paxil.suicide.risk.ap/index.html

[ncrainbowgrrl]

1. Not to sound crude here, but 11? What was the total "n" of all taking

the drug?

Knowledge of paradoxical effects are almost a given when one prescribes an SSRI...

Again- I don't mean that to be cruel or crude- I am a clinical depressive, and thank any higher power for these drugs- they've saved my life and given me back things I never knew that I could have- like true happiness...

[depakid]

3. There are several major meta-analyses out there

So in aggregate the n is huge. Of course, you're never going to see accurate and complete information that on the likes of CNN or American wire services.

All SSRI's are dangerous- especially for kids- and what's worse only one- prozak has shown even mild therapuetic effects.

All the rest show NO efficacy compared against placebo's- and of these Paxil's long been known to have the worst "suicide side effect."

Here's Mosholder's report (the one that Bush's FDA suppressed):

http://www.ahrp.org/risks/SSRImosholder/index.php

Executive summary here:

http://psychrights.org/Research/Digest/AntiDepressants/Mosholder/MosholderReport.pdf

Here's Dr. David Healey's letter to the FDA with his own review:

http://www.ahrp.org/risks/healy/FDA0204.php

[phylny]

6. Three people in my immediate/extended family take Lexapro.

One adult, one 20-year-old, one 17-year-old. The results are nothing short of amazing and wonderful.

They have their lives back on very low dosages.

[ncrainbowgrrl]

7. Thanks. I just hate these dribblings of news where reported numbers

are so small that you wonder why they bothered to report them other than the sensationalist factor...

[OhioChick]

2. I thought that all SSRI's

carried a black box warning, for adult/pediatric use?

[sweetheart]

4. I wonder if they would be so laccadiaisical...

.if the side effect were to summarily execute GSK executives.

Then they'd be upset, perhaps, and even consider recalling the drug... the
ones who were still alive... like they might become slightly ethical even....

[BlueIris]

5. How is this shit still on the market? This has been going on since '92.

I remember first reading about the HUGE rash of suicides among adoloscent Paxil users when I was TWELVE. It's never improved. And I've heard drug reps in elevators speak comfortably to each other and health-care providers about the fact that they no longer push Paxil CR on any of their clients. It's that bad. Which Senator can use Paxil and only Paxil? I want to know.

[BrownOak]

8. The real problem

is that many people are prescribing these who have no qualifications to do so. Too many family doctors are passing out SSRI's when they really don't know what the hell they are doing. After struggling with it for years I finally went in and was tested for ADHD and fit the profile. There's an element of depression that accompanies ADHD and years ago when I first mentioned the depression to my family doctor he scribbled out the prescription for Zoloft which I started taking. Guess what, it was only mildly effective and when I went in for the ADHD testing to a Psychiatrist they told me that the Zoloft was actually making the ADHD worse.

So my personal warning to all is to make sure they get evaluated by someone qualified, not your family doc who is trying to earn that Pharma trip to Cancun.

[FlaGranny]

9. So, is Tom Cruise right?

Should antidepressants be banned? I doubt it.