Top-selling drug linked to increased suicide risk

[emad]

August 22, 2005

Top-selling drug linked to increased suicide risk
By Nigel Hawkes, Health Editor
Times


ONE of Britain’s most widely prescribed antidepressants has been linked to a seven-fold increase in suicide attempts.

An analysis of trials for Seroxat involving more than 1,500 patients found seven suicide attempts among those taking the drug and only one among those taking a placebo. Suicidal thoughts were also commoner among those taking Seroxat (paroxetine), by a factor of three to one.

Almost 2.4 million prescriptions for the drug were issued in England last year.

The data was available even before Seroxat was first licensed in 1990, the Norwegian researchers found. The findings are likely to be seized on by lawyers attempting to win damages against the drug’s manufacturer, GlaxoSmithKline, in the US and in Britain. The mental health charity Mind said the results were “extremely worrying” and confirmed what it had been arguing for years.

http://www.timesonline.co.uk/newspaper/0,,170-1741916,00.html

[Tandalayo_Scheisskopf]

1. Sold in the US as...

Paxil.

[noonwitch]

9. Paxil-the pill for shy people!

I hated the way this drug was marketed. "Do you have social anxiety disorder?" As if being shy is something that needs to be medically treated. That's why God made beer.

[Sgent]

2. How do you even do this study

Something seems wrong here.

At least in the US, I can't imagine getting a placebo controlled study on this drug -- since those recieving the placebo could be significantly damaged. At the most, you might put the control group on a different anti-depressent.

BTW -- for US readers, this is Paxil.

[Mizmoon]

4. Not true - and placebos work as well as anti-depressants

Too many Americans are brainwashed to believe that anti-depressants are miracle drugs. Nothing could be further from the truth. This is from the Washington Post:
-----------------
Against Depression, a Sugar Pill Is Hard to Beat
Placebos Improve Mood, Change Brain Chemistry in Majority of Trials of Antidepressants

By Shankar Vedantam
Washington Post Staff Writer
Tuesday, May 7, 2002; Page A01

After thousands of studies, hundreds of millions of prescriptions and tens of billions of dollars in sales, two things are certain about pills that treat depression: Antidepressants like Prozac, Paxil and Zoloft work. And so do sugar pills.

A new analysis has found that in the majority of trials conducted by drug companies in recent decades, sugar pills have done as well as -- or better than -- antidepressants. Companies have had to conduct numerous trials to get two that show a positive result, which is the Food and Drug Administration's minimum for approval.

What's more, the sugar pills, or placebos, cause profound changes in the same areas of the brain affected by the medicines, according to research published last week. One researcher has ruefully concluded that a higher percentage of depressed patients get better on placebos today than 20 years ago.

Placebos -- or dud pills -- have long been used to help scientists separate the "real" effectiveness of medicines from the "illusory" feelings of patients. The placebo effect -- the phenomenon of patients feeling better after they've been treated with dud pills -- is seen throughout the field of medicine. But new research suggests that the placebo may play an extraordinary role in the treatment of depression -- where how people feel spells the difference between sickness and health.

http://www.washingtonpost.com/ac2/wp-dyn/A42930-2002May6

[CitrusLib]

15. This is true to a degree

Some short term studies have failed to show a significant difference between placebo and an active agent, however, if you look closely at the medicine's PI, you will often see that stated. It will read something along the lines of 'chemical name separated from placebo in 4 out of 6 trials'. Most short term studies measure a reduction in symptoms in a 6 - 9 week period.

However, what this article fails to point out is that long term studies, or the studies that look at relapse don't support the use of sugar pills. While the initial response can be seen due to the 'placebo affect', relapse into a subsequent depressive episode is more common and occurs quicker in patients in the placebo arm.

The scary thing about this is that once a patient relapses into the next depressive episode, the chances of the symptoms lasting longer and being more severe becomes greater.

I agree it sounds great to be able to pop a sugar pill and hope for the same outcome as an FDA approved anti-depressant, but the whole story needs to be taken into consideration. I would also add that someone shouldn't rely just on a sugar pill or just an anti-depressant. Talk therapy needs to be added to the mix to improve chances of remission (less than 7 on the HAM-D - or full recovery).

Citrus (most definitely NOT a big pharma weenie, but passionate about mental health)

[CitrusLib]

16. To get a drug approved in the U.S. trials must be done with a placebo arm.

That's how you prove the 'active' agent is actually producing the desired result. There are some very specific statistical guidelines governing what consitutes a 'significant' difference between placebo and active agent.

While on the surface it may sound unethical or inadvisable to put someone with depression (or fill in the blank with any medical condition) on a placebo, it is the FDA requiring this, not the pharmaceutical companies arbitrarily deciding to do this. In Phase III clinical trials, participants are carefully monitored, receiving more frequent follow up than any of us will ever get from our own physicians, LOL. They are also fully advised of the risks of the trial and the possibility they may be in the placebo arm. They all must sign waivers. It isn't done without full consent.

[whatever4]

3. Nothing new

It's just new that they're talking about it. MOST antidepressant drugs carry this risk, both during use and ESPECIALLY going off them.

Look especially at what these drugs are doing to our kids. And those mysterious shootings. I've read a few places there are links, but, THOSE stories aren't very hot. No one wants to believe the meds so many of us take (and I was one of them) may be the worst thing for us.

It's the drug industry. And we trust these people? I say not.

From me, a generic warning over ALL antidepressant meds. Be extremely careful going off them, and resist strongly taking the higher doses. Some studies have indicated that, even after going off them, your brain chemistry will never be the same. And no, they do not know what exactly those long-term effects entail. And some of the side effects are so poorly advertised, medical doctors don't even know to look for them. Even high blood pressure and early menopause. You'll be lucky to find any references to the side effects of these medications. You'll be prescribed other medications to treat THOSE side effects instead, without knowing the source, thinking it's normal to develop high blood pressure and the like. More medications are routinely prescribed for the suddenly more ill patient.

I was.

We're test subjects all. Be warned.

I categorically WOULD NOT give these meds to my kids.

[obxhead]

5. this is why X was out lawed.

Prior to changing X to a controlled substance there were only 7 reported deaths related to the drug. It was widely prescribed by doctors for psychological reasons. Drug companies lobbied to get rid of it because the crap they created was just that - crap. Now we have serious OD's from "street made X" and the people that X did help are getting sub-standard drugs that don't help.

The drug war - created for big business, by big business.

[landdaddy]

6. Very true

Took Paroxetine (Paxil) for PTSD. First hand experience! Weaned myself and am all the better for it!

[Jackpine Radical]

19. Try EMDR or one of the similar psychotherapies

for PTSD. I know I'm gonna get jumped all over for saying this here, but EMDR really works in most cases. Quickly too. Just make sure you have a really good, experienced therapist.

A harder-to-find, but equally effective treatment is neurotherapy (EEG biofeedback) using a protocol developed by Gene Peniston & Paul Kulkosky in the early 90's.

[smirkymonkey]

22. I also stopped taking it cold turkey and was suicidal for months

(I think it was withdrawal) finally I went back on a small dose of generic Prozac which has a longer half-life so the withdrawal isn't so bad in case I try to go off again.

Paxil helped me in the beginning, but getting off it was hell.

[Dr.Phool]

7. Anti-depressants are bad news.

A good friend of mine has severe depression, and was put on Paxil a couple of years ago. He went out and bought a shotgun, came home and told his wife, "Shoot me, then the dog, and then yourself". She had him put in a mental care facility.

And a couple of years ago, I was taking Wellbutrin (Zyban) to quit smoking, and I noticed my behavior was getting a little weird. I threw that shit away real quick.

[Delphinus]

12. I had a suicidal reaction to Xanax.

That was years ago and don't want it anywhere near me.

[kweerwolf]

8. What a shame ...

... that we can't get Tom Cruise and his Scientology cult buddies to take anti-depressants. :-(

[beetbox]

10. This Too- Exposed: How Drugs Giant Pushed Vioxx Painkiller

Exposed: how drugs giant pushed Vioxx painkiller

The growing furore surrounding the painkiller Vioxx could prove to be the most expensive legal action ever faced by a drugs company and raises questions about the marketing tactics used by a multibillion-pound pharmaceutical giant.

By Maxine Frith Social Affairs Correspondent

Published: 22 August 2005


At least 300 British patients who claim to have suffered heart attacks and strokes as a result of Vioxx, as well as the relatives of others who died, are to sue the makers, Merck, for millions of pounds in the US courts. More than 4,000 sufferers from around the world have also lodged negligence claims against Merck, with experts warning that the company faces a " potentially unlimited" flood of cases that could cost it more than $50bn (£28bn).

Merck is accused of deliberately withholding information about the potentially fatal side-effects of Vioxx from regulators on both sides of the Atlantic and misleading doctors about the risks of the drug in its desire to rush its product on to the market. Evidence given to congressional hearings in the US has also revealed how sales representatives employed by Merck were told to dodge questions about the side-effects.

http://news.independent.co.uk/uk/health_medical/article...

[preciousdove]

11. Whoa, you have to understand...

Antidepressants can and do work but the medicine and dosage has to fit the patient, there are different causes for depression, different chemicals to treat them and individual metabolisms make prescribing the right dose difficult.

You cannot give brain altering drugs to people and not watch their reaction. That is the problem. They hand you a prescription and show you the door and in the middle of the 7th night when you are in transposition your choices are dying or being locked up in hellish psych wards where people are bullied and victimized by staff and other patients. PS they take away ALL meds when you get "locked up".
So if you have any physical problem, high blood pressure, acid reflux you are at their mercy to manage to get you emergency medical treatment and they are hesitant because desperate people will do and say anything to get out of that hellish environment and regular doctors hate working with "crazy" people, hate to be called.

Depression causes people to be unable to act and that is one of the first things that comes back but what takes longer is not the underlying unbearable pain and hopelessnesses. That is why it can be "suicide pill" if there is nobody to monitor and we have no such safe serene place in modern medicine.

Depression is not merely feeling sad. Antidepressants should never be given for merely feeling sad. Depression is unjustified total hopelessness and extreme pain, sometimes physical as well as mental that sees no way out but death. Depressed people are not weak they are sick, like diabetics they lack enough brain chemicals to keep things working in balance. And yes placebos work in some suggestible patients, patients grasping as straws anyway but it is not the answer nor is eliminating antidepressants.

[Psephos]

13. Insighful post nt

[CitrusLib]

14. Bravo and might I just add

Recovery from mood symptoms often lags behind recovery from physical symptoms, i.e. lethargy. One theory behind increased suicide risk in people taking anti-depressants is that once they begin taking the medication, their physical recovery affords them the ability to act on suicidal thoughts prior to the medication alleviating the moods driving those thoughts. All anti-depressants in the U.S. carry a warning that patients should be carefully monitored at the initiation of drug therapy, during any dose changes or upon discontinuation.

I am not a proponent of anti-depressants being the answer for everyone or everything and I hold doctors who throw them at their patients without carefully monitoring or partnering with a therapist in utter contempt.

However, I do know many people who's lives were literally saved by anti-depressant therapy. Unless you've experienced clinical depression or been close to someone in the depths of clinical depression it's extremely difficult to judge what should or shouldn't be taken for relief. I have my own issues with Big Pharma, but depression is a real disease and the agents used to treat it shouldn't be dismissed out of hand because one doesn't like the source. Hold the companies accountable, but don't deny the relief to those who desperately need it.

[SmokingJacket]

17. I agree with you; however, I think Paxil is bad stuff.

Now, granted, I haven't done a scientific study, but everyone I know who's taken it ended up getting off because it made them feel emotionally dead. (Sometimes being emotionally dead is better than being depressed, of course; but it's hardly the ideal. And if you feel dead already, well, suicide seems like no big deal.) When I did a little internet research on Paxil, I found over and over people saying things like, "I couldn't cry while I was taking it." Certainly it may well help many people, but I'd like to see some really comprehensive, non-biased studies of the effectiveness of this particular drug.

If it "works" by numbing the emotional centers of the brain, it should probably be reserved for people who are suffering only the most intense emotional pain.

Suffice it to say that my own experience with it brought about one of the worst times of my life.

And the withdrawl from Paxil is known to be one of the most horrible.

[CitrusLib]

18. My best friend was put on Paxil.

Completely killed her libido and the withdrawal gave her psychotic nightmares. Wouldn't be the first one I'd recommend either!! I think there are others with less side effects and better results available.

[Avalon Sparks]

20. I took Paxil 10 years ago...

for about 8 months I took it. I was very depressed for about a year and I just wasn't myself anymore after a really bad breakup with someone. It hurt so bad at the time and it was like it took all my self-confidence away completely. Even a year after it happened my self confidence and my strenghth just weren't there anymore. I got weepy at just about everything even romotely sentimental. The weird thing is we got back together after several weeks and in fact we're married now so my year long depression wasn't continuing because of the breakup.

My doctor prescribed Paxil - it had just come out and he referred to it as the cadillac of the new antidepressant drugs.

It started working after a month. I remember the day I realized it because I was feeling a little sad that I seemed to be saying goodbye to that moody blue girl that had taken me over during the previous year. It felt like I was saying goodbye to the part of me I had gottan used to.

After that I felt 100% better - got all my confidence and my inner strength back. I didn't experience any side effects either. I just quit taking it after my prescription ran out and that was that...

My layman theory is that the major depression of the breakup altered my brain chemistry and then taking the Paxil changed it back.

Last year I took Wellbutin for 10 days while I was trying to quit smoking. I didn't cut back on cigs at the time, but the Wellbutin made me feel like I had a major anxiety disorder within a couple of days. I was restless all night and at times felt like I was having a panic attack. I wasn't expecting that reaction so I quit taking it after about 10 days. Within a couple of days I felt back to normal.

My personal belief after taking Paxil is that it works for some people. Wellbutin works for some people too, just not me. I think all drugs effect a lot of people differently - for example Percodan makes me speed like crazy but most people it knocks out. I think people should always be careful when taking any drugs they haven't taken before and start with a small dosage. I don't trust many of the new drugs and I think that too many people will pop a pill for anything before looking for alternative ways to solve the problem.

I also believe that many of the effects I had with Paxil can be achieved through regular cardio exercise.

Regular exercise has made me feel better than Paxil -

I took the drug estacy in college several times - and I swear sometimes the high I get after a rigourous workout feels even better than THAT!

[VegasWolf]

21. Paxil works for me very well!! I guess I am one of the many

patients that the drug worked for according to the above statistics.