FDA Warns of Suicide Risk for Paxil
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 given 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.
A GlaxoSmithKline spokeswoman did not immediately return a message seeking comment. However, in the letter to doctors, Dr. John E. Kraus, the company's director of clinical development for clinical psychiatry in North America, said GlaxoSmithKline continues to believe the drug's benefits outweigh its risks.
The FDA stressed that all patients, especially young adults and those who are improving, should be carefully monitored when treated with Paxil.
In 2004, the FDA ordered strong warnings about the pediatric risk of suicidal tendencies put on antidepressant labels, and began analyzing whether adults face a similar risk.
All antidepressants now carry warnings on their labels cautioning patients and doctors of the risk of suicidal behavior.
FDA Warns of Suicide Risk for Paxil
Posted 13 May 2006 - 07:09 PM
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Posted 14 March 2007 - 07:24 PM
Hmmmm. I've been hospitalized twice since this March for suicidal ideation. I was taking Paxil before March, and I'm taking more now. But I'm not considered a young adult.
Well, it's gratuitous to make the observation, but Donald Schell was no spring chicken, either. Here's a little snippet of information for you, courtesy Dr Peter Breggin. Apparently, between 1980-91 SmithKline Beecham (as it was then), conducted 83 trials of varying lengths, pursuant to bringing Seroxat to market in the UK. UK licensing requires 2 positive trials, and I suppose given an infinite number of chimps in a room with an infinite number of typewriters, sooner or later one of them will write a report saying that Seroxat's a valuable drug. SKB managed 4 trials, with 3 further trials "supporting", whatever that means. 76 failed trials.
I don't know which particular scientific school SKB or the MCA (the UK licensing body, now called the MHRA) subscribes to. The usual approach is to take the evidence on balance, see which direction it points one in, and then progress from there. The decision to license Seroxat in the UK appears to have flown in the face of this approach, because in no way does an 88% failure rate indicate efficacy, which is the prime consideration, when licensing, or so we're told. The question of negative side effects doesn't even need to be discussed, because there is no benefit to weigh against the risk.
Now, if one puts this anomaly to the Department of Health, the MHRA, the Serious Fraud Office, the Police and one's MP, as I have, one is met with a wall of silence, which is presumably regarded as the appropriate response to awkward questions. Unfortunately, it just indicates that each of these players, plus Glaxo SmithKline, is either corrupt, or incompetent, because we've moved past "innocent mistake", now that the coutermanding opinion has been given, and been derided, rather than investigated. The longer the silence goes on, the more inclined I am to think its corruption, but what would I know?
Posted 01 October 2007 - 04:29 PM
Posted 05 January 2012 - 12:16 PM
8 years ago I suffered from major anxiety/panic/depression/illusions and distortions in my perception/paranoia, severe weight loss, etc. I was seeing things on walls, on floors, on blank pieces of paper. I woke up every morning with a sick, sick feeling of terror. I cried endlessly. I experienced obsessive thoughts. I stayed in bed and was sure my life was over and done with. I wanted it to end. It was too much pain to deal with.
Then I was prescribed Paxil after trying some other drugs without success. Within 2 months I regained my ENTIRE life back; not just 50% of my life, not just 75% or 90% but 100% of my life back. The depression went away, the anxiety went away, the panic went away, the illusions/hallucinations went away, I regained my appetite and regained the weight I lost. The next seven years were the best 7 years of my life and I have Paxil to thank for it.
I relapsed again do to Compazine, prescribed to me November 2010 for a bad, bad migraine. That drug made my want to take my life and has since destroyed my life. I've tried many ssri's and mood stabilizers with not much good to speak of. I am on my road back to Paxil, which I should be on at the end of the month and only hope it can have the same affect on me as it the first time.
Even if doesn't work the second time around, I'll never forget what it did for me. My life was being held hostage and Paxil set me free and did so for the past 7 years, allowing me to live life to the fullest. I am forever grateful to the drug and the company that created it.
I am sorry if Paxil did not work well for any of you. But it certainly did for me and my brother. But if you ask me about a drug inducing suicidal ideation, I'd point to Compazine. Truth is, we're all different and drugs interact within us differently. I decided to share this because Paxil gets a bad rep a lot of times. But rarely ever do we hear good about it.
I sympathize with all of you. We are all sharing the same problems. And I know what its like for a drug to make you wanna **** yourself. I experienced that with Compazine which has a history of such adverse reactions.
Posted 07 January 2012 - 12:02 PM
Edited by tpman, 07 January 2012 - 12:02 PM.
Posted 09 January 2012 - 10:04 AM
Ditto... Same for me. Paxil really helped change my life. I HIGHLY recommend combining it with a good therapist who teaches CBT. I agree with you about Paxil having a bad rap. When people have a bad re action to a drug, they google it and come to forums, much like these, and jump on the anti drugs bandwagon. The thing is though, when people get success from medication, they are less likely to jump on forums and let everyone know its working, they will be just getting on with their lives... My opinion anyway...
Exactly. You said it perfectly. When people get better, they get on with their lives and are less likely to come back and post. To a certain degree I understand that, but I think it's important for everyone to report their success too so other people know it may help them. We're all in the same boat.
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