Paxil-Aropax-Seroxat And Other SSRI’s Caused Suicidal Thoughts In Children..


The same in adults..

same in all ages..

 

http://www.dailymail.co.uk/news/article-4431472/Anti-depressants-caused-suicidal-thoughts-children.html

 

EXCLUSIVE: ‘Daddy, please kill me I can’t do this any more’: Meet the CHILDREN prescribed anti-depressants for anxiety that ‘made them suicidal’ – as scores of parents join in a class action

  •  Two mothers have spoken out about their children’s adverse reactions to the anti-depressant drugs
  •  Sydney mother Donna’s son Seth went on anti-depressants when he was five and he is now 10 years of age
  •  Mel’s daughter Maiya, from Brisbane went on anti-depressants seven years ago, when she was six years old
  • The concerned mothers claimed their young children suffered from suicidal symptoms  

A mother who watched as her 10-year-old son rocked in a corner of his room begging for someone to kill him to end his misery has revealed how anti-depressants turned her ‘gentle, loving’ son into angry and suicidal young boy.

Sydney mother Donna is one of dozens of people involved in a class action over the use of ‘adult’ antidepressants in children in Australia.

The concerned mother spoke to Daily Mail Australia from beside her son Seth’s hospital bed on Friday after he was admitted for psychiatric care following multiple attempts to end his own life while being weaned off the antidepressant Aropax.

‘One day I came outside and he had a pair of scissors to his chest – he kept saying he was going to do it, so I had to call an ambulance,’ Donna said.

‘He was cuffed by paramedics and at the hospital I had to watch as he was held down by doctors, three security guards, nurses, and his father so he could be sedated.

Seth, pictured with mother Donna, has suffered from side effects of his antidepressants which include suicidal thoughts

Seth, pictured with mother Donna, has suffered from side effects of his antidepressants which include suicidal thoughts

The ten-year-old is now being weened off the drug is a Sydney psych ward

The ten-year-old is now being weened off the drug is a Sydney psych ward

Maiya, 13, has been on Zoloft since she was six, after she had some tantrums at school

Maiya, 13, has been on Zoloft since she was six, after she had some tantrums at school

‘He looked at me and said ‘please don’t let them do it mummy I will be good’ I will never forget that look on his face.’

Now, aged 10, he is in a psych ward of a Sydney hospital after a devastating few months where he would go from ‘rocking and crying in the corner asking his parents to kill him’, to trying to jump out of his mother’s moving car.

Brisbane mother Mel, 34, also revealed the devastating effect antidepressants had on her daughter Maiya, now 13. The child, who after taking the drugs at just six years old, started ‘fantasising about death’.

‘I will never forget the moment she looked up to me and said ‘mummy, I want to go with the angels now’, it was just after an episode which saw her crying for days,’ Mel said.

The despairing mothers said they both ‘feel like it is their fault’ for making their young children take the doctor-prescribed pills.

But the lawyer running the proposed class action, Tony Nikolic, told Daily Mail Australia he had heard the stories of up to 60 children who suffered severely after taking antidepressants.

This picture was taken two weeks ago while Seth was being weened off the drugs

This picture was taken two weeks ago while Seth was being weened off the drugs

'I will never forget the moment she looked up to me and said 'mummy, I want to go with the angels now',' her mother Mel said

‘I will never forget the moment she looked up to me and said ‘mummy, I want to go with the angels now’,’ her mother Mel said

Maiya, pictured here with her younger sisters 6 months after being off the drug is now a happier person 

Maiya, pictured here with her younger sisters 6 months after being off the drug is now a happier person

The young girl, pictured here with her mother Mel, used to cut at her hair when she got angry

The young girl, pictured here with her mother Mel, used to cut at her hair when she got angry

‘A bad night’:  Seth’s anxiety got the better of him at his brother’s birthday and he had to leave the crowd shortly after this photo was taken

‘A bad night’:  Seth’s anxiety got the better of him at his brother’s birthday and he had to leave the crowd shortly after this photo was taken

‘The complaints range from people who were given it from as young as five – to teenagers who were put on them,’ he said.

The lawyer says the fact the two drugs are ‘not recommended for children’ is little known.

‘We know the 90 days coming on and 90 days coming off are the worst times for these families – as well as any time the dose is changed- that is when there is most likely to be trouble.’

The product information on both drugs says they are not recommended for children, but doctors continue to prescribe them.

Psychiatrist and Adelaide University research leader Doctor Jon Jureidini told Daily Mail Australia the drugs are widely used to treat anxiety in young children – but there is ‘no evidence supporting it’.

He claims doctors are given ‘contradictory information’ from the pharmaceutical companies – which ‘over the years have promoted the use of antidepressants in children’ despite the warnings on the drugs which say use for children isn’t recommended.

The young girl was at her most depressed when she was 11 and 12, pictured during that time here

The young girl was at her most depressed when she was 11 and 12, pictured during that time here

Seth was diagnosed with separation anxiety and ADHD in March 2012, when he was five, at the end of the year he was put on 20mg of Aropax

‘There is information which suggests tens of thousands of young people are on anti-depressants in Australia.

‘With these so-called anti-depressants a small number of children become suicidal and violent.

‘With any drug used in children it should be monitored very closely, and parents should get a second opinion,’ he said.

Seth’s mother Donna thought she was ‘doing the right thing’ by her son when she gave him the drugs because she ‘assumed the doctors knew what they were talking about’.

He was diagnosed with separation anxiety and ADHD in March 2012, when he was five, at the end of the year he was put on 20mg of Aropax.

According to the company’s product information ‘when AROPAX was tested in children under 18 years with major depressive disorder, obsessive compulsive disorder or social anxiety, there were additional unwanted effects to those seen in adults, such as suicidal thoughts, hostile and unfriendly behaviour and changing moods.

‘The use of AROPAX is not recommended to treat major depressive disorder in children under 18, as the drug has not been shown to be effective in this age group. The long-term safety effects of paroxetine in this age group have not yet been demonstrated.’

The drugs appeared to ‘fix’ the boy’s anxiety when he was first introduced to them.

This picture was taken just weeks before going on the drug

This picture was taken just weeks before going on the drug

Seth's mother Donna thought she was 'doing the right thing' by her son when she gave him the drugs because she 'assumed the doctors knew what they were talking about'

Seth’s mother Donna thought she was ‘doing the right thing’ by her son when she gave him the drugs because she ‘assumed the doctors knew what they were talking about’

‘For five days he was almost euphoric. He had no fear or inhibitions, he was busking, he was going to class, he was like a normal child. I thought it was working.

‘Then he started having fits laughter- even when he was in trouble. Not long after that things started going wrong.’

Then the angry bursts started, which meant he became a problem at school and could no longer attend.

‘The smallest things would set him off it could be something simple like asking him to have a bath or go brush his teeth.’

He became violent toward his mother and started hitting her and trying to rip out her hair.

When he was nine, and his behaviour was deteriorating the family decided he needed more help. Doctors doubled his dose of the drug.

‘He was euphoric again and I thought I must have been wrong to think it wasn’t working the way they said it would. But then he got way worse and I knew it was the medication. Seth’s suicidal tendencies got worse.

‘His father called me one day and told me Seth needed me, by the time I got to him he was in a ball, rocking in the corner yelling ”daddy please kill me I don’t want to do this anymore” it was absolutely heart-breaking, really hard to see your own child like that,’ she said.

‘I never knew it wasn’t for children, we were never told, if I had I wouldn’t have made him take it.’

She was ten, pictured left when her 2nd psychiatrist ‘upped her dose’

The family is happier now that Maiya has stopped having angry bursts and depressive thoughts

The family is happier now that Maiya has stopped having angry bursts and depressive thoughts

Mel’s daughter Maiya, 13, took Zoloft for seven years – her depression continued to spiral out of control so doctors gave her more of the drug – which her mother says just made her sicker.

The once bubbly little girl had her two sisters, Jazlyn, 12 and Gemirah, seven, ‘walking on eggshells every day’.

‘I thought I was doing the right thing for her, I was just doing what the doctors said, I thought I had lost my baby girl to depression. Finding out the drugs I told her she had to have were making her sad kills me,’ Mel said.

‘She would attack her sisters and scream and yell – but what is worse is when she would just cry.

‘She cried for hours and hours and hours at a time it is heart-breaking to see your baby do that and not know how to help.’

Then 12 months ago Mel stumbled across information on antidepressants which revealed Zoloft, the drug her daughter had been taking, was ‘not recommended for children and could cause suicidal thoughts’.

Pfizer, the maker of Zoloft has confirmed to Daily Mail Australia that it should only be used for children aged 6 to 18 years of age to treat obsessive compulsive disorder (OCD).

The teenager pictured weeks ago with her sister is excited to be able to 'be happy'

The teenager pictured weeks ago with her sister is excited to be able to ‘be happy’

The family used to 'walk on eggshells' to avoid an explosion of anger from the girl

The family used to ‘walk on eggshells’ to avoid an explosion of anger from the girl

Maiya pictured here a few weeks before she was first given anti depressants

Maiya pictured here a few weeks before she was first given anti depressants

‘I just burst into tears when I read it – I showed my mum I couldn’t believe it. We weened her off Zoloft, which was really tough but now she is a completely different kid.

‘She is not angry and there is no aggression. We don’t have unhappy days anymore,’ Mel said.

‘She will always have anxiety but we can cope with that – better then all those days of uncertainty, unhappiness and utter sadness. We never want to see that again.’

The young girl had ‘given up on life’ by the time her mother found the information on Zoloft and had stopped going to school and playing sport.

‘By the time she was 10 she was cutting her hair every time she got frustrated – when we went to see doctors they would put up her dose.

‘I am only speaking out because I never want any parent to go through what we have been through or to have their kids suffer like this.

The young girl had 'given up on life' by the time her mother found the information on Zoloft and had stopped going to school and playing sport

The young girl had ‘given up on life’ by the time her mother found the information on Zoloft and had stopped going to school and playing sport

‘I have seen a spark in her beautiful face that I though we lost a long time ago.’

Mr Nikolic has also looked into the possibility of a class action for adults – because they ‘are not told it is so hard to get off’ and has had about 1,400 people contact him for that.

‘This is a hard one as people don’t know how to complain because they are just one little person who have to try and prove their case against a multi-billion dollar corporation.

‘There is interest in both cases but I have a firm belief a case for children for Aropax and Zoloft has a reasonable prospect of success.’

The lawyer is looking for more people effected by antidepressants after being diagnosed the drugs as children.

‘We are looking for children who have demoniacal physical and psychological disabilities – Kids who took meds and are now in jail or took meds and jumped off a balcony and are now paraplegics.’

'I am only speaking out because I never want any parent to go through what we have been through or to have their kids suffer like this,' Mel said

‘I am only speaking out because I never want any parent to go through what we have been through or to have their kids suffer like this,’ Mel said

These cases could help move the proposed class action forward.

‘The Australian court is difficult, instead of the corporation having to prove they are right the little people have to prove the medication is dangerous and whatever has happened was caused by it.’

Pfizer the manufacturer of Zoloft and GSK the manufacturer of Aropax have both been approached for comment by Daily Mail Australia.

‘Pfizer takes the safety of our medicines very seriously and we are committed to ensuring the appropriate communication of important safety information to health care professionals and patients,’ a spokesperson said.

‘Zoloft (sertraline hydrochloride) is approved in Australia for use in children with obsessive compulsive disorder (OCD) aged 6 years or older.

‘Zoloft is not indicated for use in children and adolescents under the age of 18 years for the treatment of any medical condition other than OCD.’

GSK has not yet responded to our request.

 

 

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GlaxoSmithKline to face class action over anti-depressant used on children


“…Mr Nikolic said one person joining the class action had been prescribed Paroxetine as a six-year-old, and soon began having suicidal thoughts….”

Imagine being prescribed Seroxat at 6 years old…

I wonder does Glaxo CEO Andrew Witty ever think about stuff  like that?

http://www.smh.com.au/national/glaxosmithkline-to-face-class-action-over-antidepressant-used-on-children-20160311-gngt7n.html

GlaxoSmithKline to face class action over anti-depressant used on children

Date
March 11, 2016 – 9:37PM

Bianca Hall
Bianca Hall
Legal Affairs Reporter for The Age

 

Paroxetine was once the most commonly used anti-depressant in Australia.

A Sydney law firm has launched a class action on behalf of people who as children and adolescents were prescribed the anti-depressant drug Paroxetine.

Drayton Sher Lawyers has called for expressions of interest from people who were prescribed the drug, commonly known as Aropax in Australia, when they were 18 or younger.

Solicitor Tony Nikolic​ said hundreds of people had indicated they would join the class action, which he expects to file in the Federal Court at the end of May.

Paroxetine was a commonly-prescribed anti-depressant more than a decade ago and for a time was the most commonly used anti-depressant in Australia.
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In 2001, GlaxoSmithKline (then SmithKline Beecham) funded a randomised trial of the drug that showed Paroxetine was safe for use in adolescents.

But concerns about its use persisted. In 2004 the Therapeutic Goods Administration’s Adverse Drug Reactions Advisory Committee said there was international concern about the risk of increased suicidal ideation and self-harm among children and adolescents using Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants.

“It should be noted that none of the SSRIs is approved for the treatment of MDD [major depressive disorder] in children or adolescents in Australia, but these drugs are being used for this purpose.”

A team led by the University of Adelaide’s Professor Jon Jureidini re-examined the GlaxoSmithKline research last year and found there were “quite striking” rises in the suicidal thoughts experienced by those taking the drug compared with those taking a placebo.

The review team found that 11 people who took the drug in 2001 experienced experienced suicidal thoughts or behaviours, compared with one person who took the placebo.

Mr Nikolic said one person joining the class action had been prescribed Paroxetine as a six-year-old, and soon began having suicidal thoughts.

“Now, if someone is assisted by this, fine. But they know that these things have suicidal thoughts or ideations attached to them.”

Mr Nikolic is calling for anyone who was, as a minor, prescribed Paroxetine – which also traded under a number of generic names including Chemmart Paroxetine, Extine, GenRx Paroxetine, Paroxetine Actavis and Terry White Chemists Paroxetine – to come forward if they experienced side effects.

These side effects could include suicidal feelings, attempted suicide, and causing others an injury.

Fairfax contacted GlaxoSmithKline for comment.

For help or information call Lifeline on 13 11 14.

Read more: http://www.smh.com.au/national/glaxosmithkline-to-face-class-action-over-antidepressant-used-on-children-20160311-gngt7n.html#ixzz42bl0ISQ6
Follow us: @smh on Twitter | sydneymorningherald on Facebook

Paxil/Seroxat/Aropax (Paroxetine) : “Question Of Drug’s Label Goes To Trial…”


http://www.chicagolawbulletin.com/paxil-2-16-16.aspx

Question on drug’s label goes to trial

paxil-2-16-16,ph02

James B. Zagel
Law Bulletin staff writer

A federal judge has again declined to throw out a lawsuit accusing the maker of the anti-depressant Paxil of liability in the suicide of a Chicago lawyer who took a generic version of the drug.

In a written opinion last week, U.S. District Judge James B. Zagel rejected the argument that the negligence claims brought under Illinois law by Stewart Dolin’s wife are pre-empted by federal law.

Wendy Dolin filed the suit in Cook County Circuit Court, and GlaxoSmithKline (GSK) removed it to federal court under diversity jurisdiction.

The suit maintains the labels on Paxil and its generic version are false and misleading because they failed to warn of an increased risk of suicide in adults over the age of 24.

In a motion for summary judgment, GSK argued such a warning is pre-empted by the Federal Food, Drug and Cosmetic Act.

Zagel didn’t see it that way.

A failure-to-warn claim is preempted by federal law, he wrote, citing Wyeth v. Levine, 555 U.S. 555 (2009), only if there is “clear evidence” the U.S. Food and Drug Administration would not have approved the warning the plaintiff alleges is required by state law.

GSK presented no such evidence, Zagel wrote.

In 2007, he wrote, the FDA invited GSK to discuss the option of keeping language on Paxil’s label warning of the possibility of an increased risk of suicide or suicidal thoughts in adults.

GSK didn’t take the FDA up on that invitation, Zagel wrote.

GSK, he wrote, did not ask for a formal meeting with the FDA and did not ask to include additional language on the label concerning Paxil’s possible effect on adults.

Under those circumstances, GSK failed to meet the “demanding burden” of showing it would have been futile to seek permission from the FDA to add an adult suicide warning on Paxil’s label, Zagel held.

Wendy Dolin is represented by attorneys who include R. Brent Wisner of Baum, Hedlund, Aristei & Goldman P.C. in Los Angeles.

The lead attorney for GSK is Alan S. Gilbert of Dentons U.S. LLP.

Neither attorney could be reached for comment.

In 2010, Stewart Dolin killed himself by leaping in front of a Chicago Transit Authority train at the Blue Line station at Washington and Dearborn streets in the Loop.

Dolin, 57, was a partner in Reed, Smith LLP.

He had started taking a generic version of Paxil, the brand-name version of paroxetine hydrochloride, six days before he committed suicide.

In addition to alleging the warning on the paroxentine label was inadequate, Wendy Dolin contends GSK concealed and manipulated data concerning the drug.

GSK wanted to obscure the fact that paroxetine carries a 6.7 times higher risk of suicide in adults who take the drug compared to those who take a placebo, Dolin contends.

In 2014, Zagel dismissed all claims against Mylan Inc., which made the paroxetine taken by Dolin.

But he held GSK must face claims under Illinois law of common-law negligence, negligent misrepresentation and product liability based on a negligence theory.

In the 2014 opinion, Zagel conceded GSK did not manufacture the paroxetine taken by Dolin.

But the federal Hatch-Waxman Act requires that a generic drug’s design and warning label must match those of the name-brand drug, Zagel wrote.

Therefore, he held, the brand-name maker must in some circumstances face claims based on the warnings on the generic version’s label.

In last week’s opinion, Zagel declined to reverse his 2014 ruling.

Noting that GSK and Wendy Dolin plan to call expert witnesses to the stand during the trial, Zagel also declined to hold that the Paxil’s label is adequate as a matter of law.

And Zagel rejected arguments that the doctor who prescribed Paxil for Stewart Dolin knew of the drug’s risk and, therefore, GSK could not be liable in Dolin’s suicide.

The doctor’s testimony suggests he didn’t know of the increased risk of suicide in adults over 24, Zagel wrote, and he relied on the 2010 Paxil label before prescribing the drug.

The suit is to go to trial on Sept. 19.

Zagel issued the opinion Thursday in Wendy B. Dolin v. SmithKline Beecham Corp., No. 12 C 6403.

How Do GSK Spin A (Head-Line Grabbing Land-Mark) Study That Shows Seroxat Kills Kids?


_39376520_sharise3_203

“The parents of an 18-year-old girl who committed suicide have called for better regulation of the drug she was prescribed.

Alfred and Stephanie Gatchell, from Newhaven, blame the anti-depressant Seroxat for the death of her daughter Sharise.

Now the couple, who moved to the UK from South Africa with their daughter in search of a better life, want doctors to be told not to prescribe Seroxat to people of Sharise’s age.”

(BBC News 2003)


“An Australian-led review of a popular anti-depressant drug has found it can tip young people into suicide and is no more effective than a placebo.

The research team also uncovered evidence that the drug’s manufacturer downplayed its deadly side-effects and exaggerated its benefits.

The study, published in the British Medical Journal, reviewed data used by pharmaceutical companies to help market the drug, which is sold in Australia under the names Aropax and Paxil. It is also known as paroxetine.

The company’s communications director, Bernadette Murdoch, told The World Today “we did provide an unprecedented level of data to the research team”.

(Sept 2015- ABC Australian News)


The restoration of GSK’s Seroxat study 329 is making head line news across the globe, and twitter has literally exploded with Seroxat/Paxil related tweets trending like wildfire. For those of us prescribed this horrific drug, this is good news, however not so much for the manufacturers GSK. So how do GSK counter such bad news? Seroxat was prescribed to millions of kids worldwide, and this study proves GSK knew it was harmful, so arguably what we are talking about here is perhaps a case of corporate manslaughter? or maybe multiple cases of corporate manslaughter and multiple attempts at corporate manslaughter? and if so, how does GSK spin an accusation of corporate manslaughter? how does their PR department spin the killing of kids from a harmful drug?

Well, they send out people like Bernadette Murdoch (The Australian GSK Communications spokesperson). Bernadette, it seems, is perhaps GSK Australia’s version of Alastair Benbow. Benbow was carted out by GSK to defend Seroxat and its link to suicide in the early 2000’s. He once said that there was ‘a small class of suicidal children’ in his estimates. We know now that the way GSK promoted Seroxat/Paxil (off label particularly) resulted in potentially many thousands of ‘small classes of suicidal children’ prescribed this drug.

Bernadette’s recent comments (on behalf of her paymasters – GSK) alarmed me a lot so I thought I would bring attention to them, and also- for the record- I’d like to correct Bernadette, because she seems to be selectively missing some very important details about this grave Seroxat situation; she also seems to underestimate the impact that the restoration of this study has had world-wide, and indeed the impact it will have for many years to come, both in academia and public discourse.

The 329 RIAT restoration team have said on numerous occasions just how difficult and overwhelming the whole process of obtaining, logging and reading the data was in this case. This is because GSK have set up a frustrating system whereby the only way to see the data is through a difficult ‘periscope’ type method. It is a miracle that the researchers had the will and tenacity to over come this (what I think is a- deliberate) obstacle, and it is a testament to their characters that they pushed ahead despite the immensely stressful difficulties presented to them. In light of this, it is therefore ironic, that Bernadette tries to spin it that GSK somehow had a difficult time presenting the data. GSK might have been slightly inconvenienced because they had to provide data from their study which was spun at the time as positive, when in fact it was negative; kids died because of this: these situations don’t equate to each other.

They might have presented an ‘unprecedented level of data’, but the way they presented it was akin to stonewalling, and anyhow so what if they provided the data? After 20 odd years on the market, surely they should have presented the data in the first place? Does Bernadette think her paymasters should be praised for presenting data which should never have been concealed to begin with? Anyhow, it was also the researchers who had the difficulties, not GSK, and those harmed by Seroxat have had more difficulties that Bernadette could ever imagine.

Furthermore, what Bernadette fails to mention is- this study was re-interpreted by the researchers because the original one is still being cited in order to justify the prescribing of Paroxetine to kids (mainly off label). Kids died because of the original study- how does Bernadette not understand how sinister this is? There is also the fact that there are many adults harmed and damaged from Paroxetine also (Bernadette doesn’t seem to concerned with this at all). Listening to someone like Bernadette, (or any of the other GSK mouth pieces) if you didn’t know much about Study 329, you would think that this is the first time the data had been analyzed, however it is precisely because GSK spun the negative data (from the first dodgy study) in the first place that the researchers were intent on correcting the record.

Kids died because GSK lied.

Many more were harmed.

Bernadette glosses over this, but I suppose that is what she is paid to do.

“It is not an easy process,” she said.

“These studies were conducted in the ’90s, many years ago when computer systems were very different. A lot of the notes were handwritten but we did provide all of the data that was requested by the team so that they could carry out the reanalysis.”

Bernadette is correct, these studies were conducted in the 90’s however that has nothing to do with the questions of manipulating the study itself in order to provide a deceptive result. Study 329 was a fraud. Kids died because of it. Bernadette doesn’t seem to see just how sick and twisted this is. The 90’s aren’t that long ago, and anyhow, Seroxat is still prescribed to children and adults, so I really don’t see her point here. GSK still profit off long term addicts. Furthermore, despite Seroxat making depressed kids more suicidal, GSK also made billions on it- so they have effectively profited by destroying lives. I don’t see how this can be spun as a positive thing…

Ms Murdoch said it was important to remember that “when a medicine is approved for use, it’s not just the pharmaceutical company that makes that decision”.

“There are lots of checks and balances in between, so a regulator uses all of the data that’s available on a medicine before recommending it for use for a patient,” she said.

Again, we see that Bernadette is trying to deflect the seriousness of this study and its affects on kids. She seems to be trying to pass the buck to the regulator. The regulators are toothless, incompetent, and useless. That’s a fact, however, GSK did the study, GSK pushed this drug on kids, it’s GSK who are ultimately responsible for destroying these kids lives. Kids died or were harmed because of this fraud. There is no avoiding this fact. Her comment about ‘checks and balances’ is utterly meaningless. When you have a drug company intent on manipulating results and hood winking the regulator, the system itself is useless. There were no checks and balances, that’s the whole point! and what little there was- was corrupted!

“In relation to the findings from the team’s analysis, they do appear to be in line with the longstanding view that these medicines, anti-depressants like paraxetine, are not suitable for children.

“This is widely known and clear warnings have been placed on the product label for more than a decade.”

Her last comment (above) really galls me. Bernadette is trying to make out that this study is old news. The warnings were put there because of Shelley Jofre’s reporting on BBC panorama’s four documentaries about Seroxat, a decade of litigation, department of justice investigations (particularly in 2004 and 2012) and much campaigning from the Seroxat users group, bloggers like me, Fid, and Seroxat secrets, David Healy’s RIAT team, and others.

This has been 14 years in the making. This is not old news!

GSK have been forced to release data, bit by bit, drip by drip, but Bernadette fails to mention any of this. She’s trying to make it seem like GSK were being transparent. This is twisting the facts.

I don’t know how she sleeps at night…

Her paycheck must help.

Maybe she should watch this documentary, it might help her understand a little more about the drug company she works for and let me remind Bernadette, the study she is defending (Aropax/Paxil/Seroxat 329), and the company she works for (GSK) deliberately misled doctors, the public and parents of children- this led to deaths of kids.

How can you reconcile that?

These deaths were entirely preventable.

You just can’t defend the indefensible Bernadette.

BM

Contact:

Bernadette Murdoch, Communications Director Australasia

0449 950 745 or Bernadette.l.murdoch@gsk.com 

BernadettetBern


http://study329.org/

GSKstudy329

“It’s hard to think there wasn’t some mischief being done when a severe suicide attempt requiring hospitalization was coded as ’emotional liability,'” Jureidini said during the press call about one of the specific cases they reviewed and re-classified.

http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/53583

http://healthland.time.com/2012/07/05/breaking-down-glaxosmithklines-billion-dollar-wrongdoing/

Paxil
Although the antidepressant Paxil is not approved for patients under 18, Glaxo illegally marketed the drug for use in children and teens, offering kickbacks to doctors and sales representatives to push the drug.

A government probe was launched in 2002, and it was discovered that Paxil, as well as several other antidepressants, were no more effective than placebo in treating depression in kids. Indeed, between 1994 and 2001, Glaxo conducted three clinical trails of Paxil’s safety and efficacy in treating depression in patients under 18, and all three studies failed to pass muster.

One clinical trial, known as Study 329, found that teens who took the drug for depression were more likely to attempt suicide attempt than those receiving placebo pills. Glaxo hired a company to prepare a medical journal article that downplayed Paxil’s safety risks, including increased risk of suicide, and misrepresented data to trump up the positive results of the study. The article was published in 2001, falsely reporting that Paxil was an effective treatment for child depression.

Prosecutors accused Glaxo sales representatives of then using the article to promote the use of the drug for depressed youth. Sales reps invited prescribing psychiatrists to luxury resorts for “Paxil forum meetings” where they were treated to fancy dinners and free entertainment like sailing trips and balloon rides.

Reports of teens committing suicide while taking Paxil began surfacing in 2003, and the FDA discovered that 10 of the 93 Paxil patients in Study 329 had attempted suicide or thought about it, versus one out of the 87 patients on placebo. In 2004, the FDA added a black-box warning on the drug’s label about the increased risk of suicidal thoughts in teens who take it.


http://www.cirmagazine.com/cir/nothing-to-sniff-at.php

In October 2009:

The latest development is the approval by the European Medicines Agency (EMEA) of two flu vaccines, Pandemrix, (GlaxoSmithKline) and Focetria (Novartis). Licenses will be granted on approval by the European Commission. These are a key part of the flu strategies of governments around the world. In the UK, the government has contracts in place to supply up to 132 million doses of vaccine.

There has been some concern, however, about the speed at which the new vaccines have appeared.

GlaxoSmithKline spokesperson, Bernadette Murdoch, explained that although the vaccine is new, a lot of the work on it took place before the pandemic was declared. “We carried out clinical studies which led to the 2008 approval of the vaccine, and we are carrying out further 16 clinical studies, involving about 9,000 people and all that data will be provided to assess that. We are still going to continue to monitor its safety as we go forward.”

Researchers link Pandemrix flu vaccinations to narcolepsy

Lawrence Steinman. (Courtesy of Lawrence Steinman)

An international team of researchers has found evidence that the GlaxoSmithKline Pandemrix flu vaccination – which was widely distributed during the 2009 swine flu pandemic – may have caused rare cases of narcolepsy. Their study, which was published July 1 in Science Translational Medicine, described that the vaccination stimulated antibodies to attack receptors in brain cells that help regulate sleep.

Lawrence Steinman, a professor of pediatrics and of neurology and neurological sciences at the Stanford University School of Medicine, and his collaborators sought to determine why the Pandemrix vaccine

According to the study, Pandemrix, which was given to more than 30 million Europeans, strongly suggested to trigger an autoimmune reaction that led to narcolepsy in some people who are genetically at risk.
The researchers propose a “hit-and-run” mechanism where high levels of the H1N1 protein stimulate the production of large amounts of antibodies, which may remain in the blood for months, to both the virus and the hypocretin receptor. Under certain conditions, the blood-brain barrier can be altered, allowing the antibodies to enter the brain where they latch onto hypocretin receptors, possibly targeting these brain cells destruction by the immune system.

BM


http://www.thejournal.ie/pandemrix-narcolepsy-link-study-1447040-May2014/

“Our study found a significant, 13.9-fold higher, risk of narcolepsy in children/adolescents vaccinated in Ireland with Pandemrix compared with unvaccinated children/adolescents,” said the researchers.


So far 31 million doses of Pandemrix have been administered in 47 countries, GSK said. It has received 335 reports as of Jul 6 of narcolepsy in people who were immunized with Pandemrix, of which 68% were from Finland and Sweden.

http://www.cidrap.umn.edu/news-perspective/2011/07/ema-narcolepsy-review-restricts-pandemrix-use-kids-teens

The Huffington Post: A Seroxat Horror Story


http://www.huffingtonpost.co.uk/pam-warren/antidepressants_b_5536823.html?utm_hp_ref=uk-lifestyle&ir=UK+Lifestyle

Who Should Prescribe Anti-Depressants?

Posted: 30/06/2014 16:00
Having got me to understand the physical aspect of my depression and what was happening (previous article), Dr Cantopher then turned his attention to the anti-depressants I was being prescribed. 

2014-06-27-lotsofpillbottles.jpg
I have always hated taking tablets unless I really, really have to. Unfortunately, for all the years I avoided taking even an aspirin to treat a headache, my injuries led me to the necessity of taking a lot of various forms of medication in order to cope with the pain. I swear that most days you could have picked me up and rattled me like a maraca!

Once my PTSD had been diagnosed I was quickly put onto an anti-depressant called Seroxat by my then treating psychiatrist. At the time this was a fairly new drug to have entered the market and I don’t think that the side effects were properly known. As we are all different I appreciate that Seroxat may be the right anti-depressant for some and I agree that with the state I was in some form of medication was necessary. However for me , Seroxat turned out to be a worse enemy to me than the depression. Perhaps it reacted badly with the cocktail of other drugs I was being prescribed though, from reading up on other peoples experiences of it, I am not so sure.

My mood swings varied wildly, I sometimes hallucinated and imagined things that were not there. My behaviour was erratic and unexplainable, I was verbally abusive and began thinking of all the ways I could end my life. To shut out the jumble of thoughts that I could not seem to control I began to drink…heavily…which just exacerbated the problem.

While I was behaving totally out of character, the real me, the real Pam, felt like a deeply buried voice within me that no-one could hear. From inside myself I would watch and listen with horror as the automaton that was my body and voice continued down this path. Luckily my family came to realise that there was more wrong with me than just the PTSD so sought a second opinion on my behalf.

This led me to Dr Cantopher who realised what my symptoms were, was pretty damming in his opinion of Seroxat and immediately took me off it. He had to put me onto a new type as I was not well enough to come off anti-depressants altogether, but he knew what the potential side effects might be and monitored my progress on them. “We are going to treat these as you would a plaster cast on a broken leg”, he advised, “we’ll keep you on them while your mind heals and when mended we’ll wean you off them”. This course of action, while it was years before I could be weaned off, proved extremely beneficial in my case though, like many bad leg breaks, my healed limbic system will always be a little weaker than before.

Remembering Laurie And Ryan Yorke : Mother Speaks on Seroxat/Paxil Withdrawal


http://isepp.wordpress.com/2012/04/03/mother-speaks-on-paxil-withdrawal-until-you-have-witnessed-it-you-can-not-even-imagine-what-it-is-like/

Mother speaks on Paxil withdrawal: “Until you have witnessed it, you cannot even imagine what it is like”

Posted on April 3, 2012 by
3 Votes

Posted by Maria Mangicaro

Laurie Yorke, a NJ nurse, shares her family’s experience at one of the ISEPP (formerly ICSPP) conferences.

For more information on Paxil withdrawal please visit www.PaxilProgress.org

PaxilProgress is a peer-to-peer message board community for people to share their personal experiences with taking antidepressants, and allows others to ask questions, and to learn from each other, and make their own, more informed decisions.

The International Society for Ethical Psychology & Psychiatry is an independent organization which currently takes no monies from external sources.  Our annual conferences are a major outlet for cutting-edge information in mental health.

The ISEPP 2012 conference, “Alternatives to Biological Psychiatry II: Treatments That Work“, is scheduled for November 2-3 at the Airport Marriot Hotel in Philadelphia, Pennsylvania.

The Foundation for Excellence in Mental Health Care will be joining ISEPP at the conference and will be leading a strategy session on Satuday afternoon. We are also collaborating with MindFreedom International which will host a one-day event on Thursday, November 1 at the hotel and the The Philadelphia Society for Psychoanalytic Psychology (PSPP) which will be hosting an event on the afternoon of Sunday, Novmber 4, 2012 at the hotel.

One of the keynote speakers will be Dr. Grace Jackson, author of Rethinking Psychiatric Drugs: A Guide for Informed Consent and Drug-induced Dementia: a perfect crime.

Click here for registration information.

**THIS VIDEO DOES NOT PROVIDE MEDICAL ADVICE. The content is not intended to be a substitute for professional medical advice, diagnosis, or treat.  Abrupt stopping of psychiatric medications can be dangerous, please consult your physician to make any decisions about changes in psychiatric medications.

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Looking for more information on effects of paxil withdraws after taking it for ten years and the doctor stops it all of a sudden. Any information will help. Thank you

Aropax (Seroxat/Paxil/Paroxetine): “Once You’re on it You Can’t Get Off”


“And that’s the most terrifying thing of all.”

http://www.patientsrights.org.nz/aropax-nation

Aropax Nation

AROPAX NATION: A HARD HABIT TO BREAK

This article was written by Clare Swinney and published by Ian Wishart in the Investigate Magazine in April 2004.http://www.investigatemagazine.com   It has been made available to readers on this website by kind permission of the author.

Are modern anti-depressants actually making people crazy? CLARE SWINNEY investigates the growing controversy over the side effects and withdrawal sympoms of the SSRIs:

Janet Frame touches on the association between doctors and patients in Faces In The Water, (1980) on page 28. “The doctor would pause sometimes to inquire, smiling in a friendly manner, but at the same time glancing hastily at his watch and perhaps wondering how in the hour before lunch he could possibly finish his rounds of all the women’s ward and get back to his office to deal with correspondence and interviews with demanding puzzled alarmed ashamed relatives”. Although this was set in an asylum in New Zealand in between the First and Second World Wars, it bears a familiar flavour.

Propelled by a need for efficiency, psychiatry’s enthusiasm for symptomatic, push-button remedies, has led to life’s transient symptoms, such as forms of mild depression, to be clinically diagnosed and, once diagnosed, seemingly quickly alleviated, if not eliminated, by a pharmacological intervention. Many clinicians today consider it more practical, economical and speedier to prescribe medication than psychotherapy. But is dispensing tablets, such as the family of Selective Serotonin Reuptake Inhibitors (SSRIs), the best course of action for treating common ailments, such as mild to moderate depression? Or is it doing damage to those it is supposed to be helping?

Doctors have administered and prescribed a series of addictive drugs as sedatives for psychological distress since the early 1800’s, ascribing to the belief that they wouldn’t lead to dependence, and if they did, their patients were probably accountable in some way. Initially, there was opium and alcohol, then heroin, morphine and cocaine. Then in came the bromides, barbiturates and associated compounds. And an assortment of benzodiazepines ensued, including Librium and the iconic one, Valium, which was deceptively denoted “mother’s little helper”.

As a consequence of the relationships between governments, almighty drug companies, the medical profession and patients, it took over two decades of comprehensive use before benzodiazepines were accepted as addictive. When this occurred in the late 1980s, prescriptions for them went into sharp decline, but by then, thousands of addicts had been spawned worldwide, many for whom the sole motivation for continuing to take the drugs was that it was too distressing trying to cease using them. They were dependent upon them – in a similar manner some get hooked on drinking. It wasn’t an obvious addiction. Its effects were, for the most part, respectably concealed behind the white net curtains of suburbia. But the households were haunted.

A few weeks ago, an evening talkback show on Radio Pacific elicited calls from people who’d taken SSRIs, the antidepressants which soared in popularity when benzodiazepines lost favour. SSRIs affect the brain’s ability to reabsorb serotonin, a neurotransmitter in the brain, which is supposed to affect mood, sleep and appetite. That night numerous people phoned the radio station. Said the program’s host: “We were inundated”. People related how difficult it was to come off SSRIs owing to a melange of atrocious withdrawal symptoms. Some divulging that they experienced anger, fierce rage and suicidal thoughts. A number regarded it as too difficult to give up, and regarded their medication as addictive.

Difficulties coming off the SSRIs are well documented. An Internet search of MEDLINEPlus using the search terms “SSRI” and “withdrawal” in combination drew out 278 entries and in Google, 51,900. Some experts stated that many patients, who go off the drugs, mistake their withdrawal symptoms for a return of the original symptoms they were using the drug to treat. They then commonly restart the medication. Other experts said that in many cases there may be a re-emergence of the symptoms people took the drug to alleviate, such as panic attacks for example, and that this was the deciding factor for some patients who restarted their SSRI medication.
Aropax, (paroxetine), which has a relatively intense impact and short duration of action, is associated with the most severe withdrawal reactions. It was approved for introduction into New Zealand in April 1992 and is now the most widely prescribed antidepressant in New Zealand – 209,054 prescriptions were written for it in 2003 alone. And this states Pharmac, the government-sponsored Pharmaceutical Management Agency of New Zealand, is in spite of it having come under scrutiny in Europe and North America, owing to reports linking it to an increased incidence of suicide and a heightened risk of dependence.

In 2003, the number of prescriptions for expensive antidepressants rose and cost taxpayers an additional $4.6 million from the year before. Clinicians’ preference for the SSRIs: Aropax, Fluox and Cipramil, over the old style of antidepressants, such as the tricyclics and monoamine oxidase inhibitors, accounted for most of this unwelcome gain.

One of the reasons for SSRIs popularity is that doctors do not regard SSRIs as addictive. Withdrawal from SSRI’s, such as Fluox and Aropax, can cause a range of unpleasant symptoms, such as dizziness, insomnia, virtual reality nightmares and headaches, but this in itself is not indicative of an addiction. According to Associate Prof Doug Sellman, a psychiatrist who specialises in addiction research at Christchurch, there is a crucial difference between a withdrawal syndrome associated with drugs taken for reward and attendant drug-seeking behaviour and a discontinuation syndrome from medications generally. He states: “There is no doubt that there is a discontinuation syndrome from SSRIs, such as Aropax, but not a withdrawal syndrome that will reignite drug-seeking behaviour.”

“Oh yeah?” responds Jane, one Auckland woman who tried to give up Aropax six weeks after starting. “By day five of climbing the walls, fighting the urge to kill yourself, fighting the urge to kill somebody else, feeling nauseous with the most horrific dreams I’ve ever experienced in my life – of course you go crawling back and start taking the drugs again! I suggest these doctors try taking these drugs themselves for a while, then try kicking the habit. Then you’d see their views change.”

Interestingly, a US clinician interviewed by Time magazine dismissed the link between SSRIs and suicides, saying a study of suicides failed to find evidence that an SSRI had been taken in the hours beforehand. But according to Jane and others, he missed the point – the suicidal thoughts come when you try to give up the drug, and you haven’t taken a pill.

Jane had gone to her doctor for exhaustion, and came away carrying a 20mg a day prescription for Aropax. When some of the side effects started to kick in after four weeks, she went back to the medic who decided to double Jane’s dose to 40mg a day. Things went from bad to worse – and the discovery that Aropax is one drug you can’t quit cold turkey.

“Once you’re on you can’t get off,” she says. “And that’s the most terrifying thing of all.”

The Diagnostic And Statistical Manual of Mental Disorders, 4th Ed., (DSM IV), is the clinicians’ bible. Amongst other things it categorises 307 different types of depression, other mental illnesses, the personality disorders, and substance abuse problems. According to this guidebook, ‘addiction’ requires at least 3 of 7 criteria to be met. (p. 181).

Offers Dr Alistair Dunn, a GP, who specialises in the field of addiction: “A withdrawal syndrome is but 1 of those 7 criteria. I don’t think taking an SSRI, such as Aropax, fulfils any of the others. And I don’t regard it as addictive because it may in some cases, require careful tapering off. If medication for blood pressure is stopped abruptly, a rebound rise in blood pressure can result, or in other cases, a return of angina may occur. Therefore, it must be tapered off slowly. But that doesn’t make it addictive. Addiction does not equal withdrawal syndrome. It’s much more complex, involving effects across a wide range of domains in someone’s life.”

A DSM IV diagnosis of addiction requires evidence of outright abuse. One of the 7 criteria assigned is self-destructiveness manifested in drug-seeking behaviour, such as visiting multiple doctors or driving long distances. Obviously, this would be most unlikely to occur with an SSRI, given that physicians readily prescribe and actively encourage their use. Asserts Dr Dunn: “It can sometimes take a long time for a GP to convince a patient to try a medication, even when the need is obvious to the doctor and the benefits are significant”. Dunn seemed quite annoyed this article was being written. “What about the benefits of the medication and the harm of someone stopping it because they have read an article stating it’s an addictive drug”, he queries.

A review of the medical literature on the SSRI withdrawal syndrome by Tamam and Ozpoyraz, concludes that the best approach for a doctor in dealing with patients experiencing withdrawal symptoms is to educate them, reassuring them that it is a reversible condition, while reinstating the original SSRI, and further slowing the rate of tapering off the drug. (Source: Adv. Ther, 2002).

Anna De Jonge of Hamilton is the Liaison Officer for the Patients. Rights Advocacy Waikato Inc, (PRAWI), a group

of 570, that advocates having will power over pill power. PRAWI’s principal aim is to empower people with information and knowledge. And it, amongst other activities, assists victims of medical misadventure to make formal complaints. Says De Jonge, who is opposed to the use of the SSRI’s because she says they’ve been associated with “suicide, murder, self-harm and mental turmoil,” if in time SSRI’s turn out to be no improvement on latter-day antidepressants, this will be owing to and in spite of the minimisation of the risks of taking them. “If SSRI’s were in some regard, drugs of dependence, but not being categorised as such, it will increase the element of risk of self-harm using them, and their effectiveness will naturally be over-estimated,” maintains De Jonge.

Is their effectiveness being over-estimated? Effectiveness of numerous drugs is. Although it’s seems baffling given the drug industry’s culture of maximum possible sales for maximum possible profit, Dr Allen Roses, an employee of GlaxoSmithKline, (GSK), which is Britain’s largest drugs empire, publicly disclosed that most prescription medicines don’t work on most of those who take them. Amongst those working in the pharmaceutical industry, this was no secret. Seemingly paradoxically, Roses, worldwide Vice-President of genetics at GSK, stated late in 2003 that most drugs only work in 30-50% of people – a substantial proportion prescribed some of the most expensive drugs do not derive any benefit from them at all.

Could this be a reason why the SSRI, Prozac, which is the most widely prescribed antidepressant drug in history, made a fortune for the company, Eli Lilly, yet couldn’t save the CEO’s own spouse? In May 1994, Mrs Marilyn Tobias, the wife of Randall L Tobias, chief of Eli Lilly, committed suicide. Tobias told a magazine in 1995 that his wife was depressed and had tried Prozac.

Prozac was approved for use in New Zealand in February 1988. Eli Lilly’s www.prozac.com website states: “since its introduction in 1986, Prozac has helped over 40 million patients worldwide, including those suffering from depression”. Yet, as Charles Medawar, who has worked in consumer protection in the UK and held appointments with the World Health Organisation, pointed out “there has been no discernible effect on suicide rates, since the start of the new war on depression”. Suicide rates in the USA, where SSRIs have been most used, and in England, provided no evidence of any national dose-response. (Source: “The Antidepressant Web – Marketing Depression and Making Medicines Work,” in International Journal of Risk and Safety in Medicine, 1997, p.23).

And now the 24,500 or so anti-depressant prescriptions provided for treating children and adolescents each year in New Zealand are under scrutiny as researchers look for a possible link between SSRIs and suicide. SSRIs are not registered for use here in children, but some doctors prescribe them to youngsters. In Britain, authorities have advised doctors not to prescribe the SSRIs Lustral, Cipramil, Cipralex, and Faverin to young depressed people as clinical trials found a higher rate of insomnia, agitation, weight loss, headache, tremor, loss of appetite, self-harm, and suicidal thoughts in children taking the drugs.

For years, drug manufacturers and regulators in the UK and US maintained that antidepressants would reduce the risk of suicide. Perhaps most notably, Dr David Healy, Director, North Wales Department of Psychological Medicine, a psychiatrist with an international reputation, having authored 12 books and over 120 peer-reviewed articles, strongly disputes this claim. Healy has examined many confidential internal drug company documents, to which he gained access in his capacity as an expert witness in a lawsuit against GSK. These internal documents, Healy states, show the results of the company’s own clinical trials testing the SSRI, paroxetine (Aropax). The evidence, he alleges, shows that rather than reducing the risk of suicide, the drug increases it. He told the BBC that the evidence indicates that roughly 1 in 60 people who go on this drug makes a suicide attempt, whereas only 1 in 550 on a placebo or sugar pill do. Dr Healy says both the drug company and the regulators in the UK and US knew this data for 13 years.

At the heart of the problem, Healy believes is that SSRIs cause akathisia, a syndrome involving motor restlessness, and it is this that causes some patients to commit suicide. GSK’s own studies, and Healy’s, show that SSRIs can cause 1 in 4 healthy volunteers to become agitated. Healy, who is also involved in legal action against Pfizer, following the suicide of the 13-year old American called Matthew Miller, who hanged himself after taking the SSRI sertraline for a week, carried out a trial in healthy human volunteers comparing sertraline with Pharmacia’s Edronax, which does not work on the serotonin system.

The results showed that one third did not respond well to sertraline at all. Of this third, 2 volunteers became acutely and seriously suicidal just being on a normal clinical dose for 2 weeks. They were absolutely normal people. Healy claimed that the archives of the 2 companies contained evidence supporting his own findings.

In excess of 30 studies on sertraline carried out before the drug was licensed, showed that 1 in 4 people taking the drug became agitated. The healthy volunteer studies carried out by the company showed that about 50% of patients suffered withdrawal problems when they came off the drug. Healy claimed this suggested that some patients had become physically dependent on the drug. But instead of warning patients and doctors, he said the company argued that the patients with problems coming off drugs were suffering a recurrence of depression and needed to resume medication.

It can be difficult to conceive of what could be going through someone’s mind when they consider suicide. According to 31-year old, Ashburton mother of two, Diane Blakemore, of how she felt while taking an SSRI: “My life was totally miserable. I wasn’t living – I was surviving. I had horrific nightmares, usually quite satanic. Irrational fears on the drug, were the norm too”.

She continues: “I would lie on the couch, too lethargic to move and felt suicidal, as I was highly anxious and depressed. My whole body had inner shakes, I was sweating all over and I had headaches and unbearable muscle tension. My nervous system was overstimulated to the max”.

“I felt suicidal because I felt like this and really didn’t like it. I didn’t know how to handle it. The doctor told me to keep taking the tablets, saying that these side effects would go away after 4 weeks. But they didn’t.”

“I’d never had any of these symptoms prior to taking the drug. I recently had a bladder and uterine prolapse with terrible backache as a result of giving birth, which made me feel very tired. And as my child had colic, I had to walk the floor, and this walking made my backache worsen. The longer I was on my feet, whether I be sitting or standing later, the worse the pressure and resultant pain would be. And it affected my legs too, as they felt heavy. My backache would ease if I lay down and I took my body weight off my sacrum – so I knew it wasn’t a psychological problem. And I was aware that prolapses might cause this pressure pain. But unfortunately, I just did what the doctor told me and took the medication for the ‘chemical imbalance’ I was told I had.” In this case, the chemical imbalance her doctor referred to was a diagnosis of depression. Blakemore wrote to members of parliament in March 2004 regarding her experiences. In her opinion the medical profession is too ready to categorise behaviour as indicative of depression and far too disposed to prescribe antidepressants.

As with the withdrawal syndrome, problems such as Blakemore’s SSRI experiences have been documented, yet SSRI popularity continues to soar worldwide. For example, in the UK in 1992, 500,000 prescriptions were written for SSRIs. A decade later, the figure was 15 million. Likewise, in 1993 in New Zealand approximately 50,000 scripts were written for SSRIs and by 2003, this mushroomed to almost 450,000.

Investigate asked GlaxoSmithKline how many packs of Aropax – a drug subsidised by the government – they sold in 2003, in New Zealand. Neil Jarvis, the sales manager responded: “Unfortunately the information you have requested cannot be provided. As you appreciate, sales data is confidential and is not readily available from a majority of pharma [sic] companies.” While GlaxoSmithKline regarded this as classified information, it is in the public arena that in 2003, doctors wrote 203,636 prescriptions for Aropax and that the Ministry of Health paid $19,269,716 for it. Pacific Pharmaceuticals, which supplies the Prozac equivalent, Fluox, a drug which is also subsidised by the government, told Investigate that the company sold 193,000 packs of capsules in New Zealand in 2003. Each pack contains 90 capsules.

In light of the show-stopping number of these drugs being sold each year, it is little wonder the Radio Pacific talkback session on SSRIs became deluged with callers a few weeks ago. When the BBC broadcast a show on SSRIs in the UK in late-2002, it also received a huge response from viewers – 1,374 e-mails and over 5,000 telephone calls. A published medical paper presents an analysis of these e-mails and finds that 17% rated paroxetine as “very positive to worth taking”, 48% rated paroxetine negatively, from not worth taking to severely disabling, and 35% were uncertain, giving no or insufficient evidence of having taken the drug.

Investigate went to a pharmacy to take photos of SSRI packs. The pharmacist, who does not wish to be named, regarded the number of people he knew who were taking it as “sad”. Although not being handed out like sweets by the medical profession, because of restrictions, he knew of people taking it because their friends were.

According to Dr Jay M. Pomerantz of Harvard University, since antidepressants have severe adverse side effects,

most patients stop taking them before they might have any positive effect. Investigate found evidence that SSRIs aren’t being swallowed according to doctors’ orders. A near full pack of Aropax was found in a skip outside someone’s apartment. A friend handed me 35 Fluox tablets to take photos of, saying he didn’t ask his doctor for anything for depression, but was prescribed them. He took the medication for 15 days, before deciding it more prudent to address the cause of his unhappiness. In addition, there were packs of Prozac 20 located at a relation’s residence, abandoned in a kitchen drawer.

It is not difficult to fathom that the medical profession is eager to promote these drugs’ use.

The British government is now cracking down on reckless over-prescribing of SSRI drugs, which are depleting public health care budgets. New draft guidelines from the UK.s National Institute of Clinical Excellence (NICE), the British government agency that decides which drugs should be available through the National Health Service, state that antidepressants are not recommended for the initial treatment of mild depression in adults “because the risk-benefit ratio is poor”. NICE will publish guidelines for the treatment of depression in children in 2005.

Investigate asked Pharmac’s Medical Director, Dr Peter Moodie, if there were any plans to curtail the burgeoning sum being spent on SSRIs here. Moodie advised that a cheaper source of paroxetine was in the process of being sourced, as the patent for the drug had expired. However, he said it would take some time before a cheaper, generic equivalent to Aropax could be obtained, as its producer is fighting tooth and nail to keep its market share. He said it would help reduce costs to taxpayers if doctors were more prepared to look at the basic causes of depression, before reaching for a prescription pad.

Do SSRIs work? They inhibit serotonin reuptake. They inhibit the action of receptors on cells near neurons, thus making the serotonin stay in the synapse longer and consequently activate the next neuron for a longer duration than would otherwise occur. However, it is merely hypothesised that depression and anxiety are related to abnormal levels of serotonin and altering its effectiveness with an SSRI may alleviate the symptoms.

Depression, which, as mentioned, falls into 307 categories in the DSM IV, is also believed to be associated with abnormal levels of other neurotransmitters, such as norepinephrine and dopamine, which can, some experts say, be regulated by other drugs. A problem with prescribing the “right” drug to treat depression, is that there is no scientific way to prove that a person has a low or high level of a specific neurotransmitter – so finding the appropriate drug for someone is deemed to be on a trial basis.

Ironically, while doctors continue to give SSRIs the red carpet treatment, numerous studies have demonstrated that drugs are not required to treat depression. Placebos or dummy tablets, such as disguised sugar pills, can do just as good a job. Indeed, numerous reputable studies have found that patients may respond to placebos, in much the same way they respond to antidepressants. One such study, a major government-funded study in the US, found that neither Zoloft, nor St. John’s wort are any more effective than a placebo in patients with major depression. (See: JAMA, Vol. 287, No. 14, April 10, 2002).

Similarly, research by a team led by University of Connecticut psychologist, Irving Kirsch, did an analysis of clinical trial data submitted to the US FDA for the 6 most widely prescribed antidepressants in the US, that were approved between 1987 and 1999. Namely fluoxetine, paroxetine, sertraline, venlafaxine, nefazodone and citalopram.

The group found that 80% of the response to medication was duplicated in placebo control groups. Thus, those who received only the pretend pills felt better to about the same degree than those who took the SSRI drug did. The average difference in improvement was only 2 points on the Hamilton Depression Scale, which produces scores up to 50 or 62 points, depending on the version used. The difference was so small that it was obvious the people got well because they expected to.

Kirsch et al concluded that if the drug affect is as small as it appears when drug-placebo differences are estimated, then there is little justification for the clinical use of SSRIs. (Source: “The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration,” published by American Psychological Association, 2002).

These studies raise very serious questions about whether SSRIs should be the treatment of choice for depression -questions that seem to be falling on deaf ears.
A placebo poses no risk and costs next to nothing, and research findings have demonstrated repeatedly that they work as well as antidepressant medication. So why do psychiatrists prescribe expensive SSRI drugs despite the serious risks and side effects? The risks associated with highly prescribed antidepressants can be severe: in some patients they produce suicidal thoughts.

Investigate asked Pharmac if the many studies that have shown a placebo is as effective in treating depression as an SSRI, have influenced any decisions Pharmac has made? Dr Moodie said: “No. We are aware of those papers. How quickly doctors prescribe SSRIs is up to good medical practice. If Pharmac perceives that there is something obviously going awry in the prescribing of various drugs, then there is a responsibility to promote responsible use.”

Aropax is repeatedly advertised in full-page ads in the New Ethicals Catalogue, a handbook used by GPs to select medications, as “more than just an antidepressant.” Indeed, SSRI antidepressants are advertised and prescribed as safe for a myriad of complaints that have nothing to do with severe, clinical depression for which they were approved.

Dr. Pomerantz notes that “SSRIs in particular, have replaced benzodiazepines as the drugs of choice when the physician is at a loss for what to do to get a patient out of the office.” And: “If what we are seeing is a pattern of widespread antidepressant prescribing for a multitude of subsyndromal, amorphous, patient complaints, it suggests that antidepressants have become the modern-day sugar pill, or placebo. It is quite likely that antidepressants have largely replaced benzodiazepines in this regard.” (Source: Antidepressants Used as Placebos: Is That Good Practice? in Drug Benefit Trends 15 (8), 2003).

If antidepressants are being prescribed as a placebo, New Zealand taxpayers are paying the pharmaceutical companies a ridiculously high price. It is a joke and a telling one. We would be misguided blaming the drug industry for this state of affairs. Effective corporate monsters like GSK and Eli Lilly exist to make a profit for shareholders, not to help provide premium health care for people. Providing good health care is the job of the medical profession.

When Coming Off Antidepressants:

Work closely with your doctor.
Taper the medication. Experts agree that the best way to avoid withdrawal side effects is to wean off the medication. By reducing the dosage in small increments, the brain can adjust to the change in chemical balance and slowly adapt to living without the drug. For some people, experts say, this process may take up to a year.
Get psychotherapy or counselling. While drugs can often mask problems, therapy can help address underlying causes. Psychotherapy is far superior to medication in the long term.
Exercise. Even if you don’t feel like it. Force yourself to. There’s strong evidence exercise plays a major role in lifting one’s mood and reducing stress.
Eat a healthy diet.
Laugh. Laughter is one of the best medicines.

How Do They Sleep At Night? : Seroxat (Paxil) Birth Defects


VANCOUVER — Pharmaceutical giant GlaxoSmithKline says it conducted its clinical trial program for the antidepressant drug Paxil appropriately in marketing the medicine for use by women of child-bearing age.

The statement comes after a B.C. Supreme Court judge certified a class-action lawsuit launched by a B.C. woman whose daughter was born with a hole in her heart.

Lawyers allege the drug caused birth defects when taken during pregnancy, and say the company didn’t properly warn doctors about the risks.

In a statement, spokeswoman Michelle Smolenaars Hunter said the company acted appropriately in its clinical trials, marketing and safety monitoring, and updated pregnancy information as new information became available.

Faith Gibson’s daughter Meah Bartram was born just two weeks before the company warned doctors that taking the drug during pregnancy could increase the chance of cardiovascular defects.

One of Gibson’s lawyers, David Klein, argues the company ought to have known the risks before then, and is pointing to small-scale studies and studies on similar products that were already available to the scientific community.

Read more: http://www.theprovince.com/health/Drug+company+says+acted+appropriately+Paxil+anti+depressant/7661917/story.html#ixzz2FWWepxbM

Patientsville : Seroxat Patient Reports


http://www.patientsville.com/medication/seroxat2_side_effects.htm#reports

Showing 21 comments

  • G00037805

    I have been taking seroxat 20mg for over three weeks now and have been feeling very dizzy and nauseous, also I get severe headaches in the mornings

  • Maya

    Hi doctor , good morning
    My aunt is taking a seroxat 20 mg now being 25 days and she is asking if he can stop it

  • Khalid Saeed

    Whether the seroxat may be taken during pregnancy?

  • stanes

    been taking seroxat for 10 years , 20mg , how anyone can say this drug is not addictive is beyond me, suffered withdrawals numerous times , and not to say when i started this drug my symtoms went 100% worse…

  • norma

    i want to stop seroxat how i can doit?

  • gary campbell

    taking the the tablets no problems ,if i missed one no after effects felt great. now the doc has taken me off them different ball game , im angry , will argue with any one stressed out
    get annoyed at the smallest thing. before this would not have happened i was too layed back to carenothing bothered me now its like im back in londonderry refighting the irish war all over again at my time of life i cant be fighting anymore wars in my brain

  • Marty

    I have had my dose increased from 20mg to 30mg and am feeling restless and very uneasy.
    This was done three weeks ago.
    My partner has said that in my sleep I am shouting out loudly, arms and legs are all over the place, and is concerned
    Has this happened to anyone else, Im not in control of my emotions

  • Johnny

    I just had my first dose of Seroxat this morning (8am), and until now (9pm) i’m still dizzy and i have this feeling that i’m going to collapse. i guess i have to quit taking it starting tomorrow.

  • carol from essex

    I’ve been on seroxat 20 mg for years and I seem to have the same symptoms as you apart from the thought of death. mind you I am 63 so it is probably on it’s way to me anyhow. The weight and lack of motivation are definately what I have, whether one has to do with the other I don’t know. I wo der if perhaps I need to take more to lift me out of this. i

  • Nal

    I took yesterday seroxat cr 12.5 mg the reason was mild depression and anxiety..
    now I feel nausia and I vomit I cant eat and there is difficulty in sleeping..

  • thomas

    i wish i could get off seroxate ,i feel like my head is going to explode most of the time and if i miss a day without it i feel like the whole world is falling down around me not to mention feeling like i want to get sick.

  • liliane

    I feel tired all the time and i dream weird dreams ,feel sleepy all the day.

  • Mark

    I have been on seroxat for 10 years, trying to come off but the dizziness is bad. Gong from 10mg to 9.5mg. Half mg and bad dizziness. Has anyone used anything to help the dizziness?

  • claire

    i am on saroxat for 6 years and i find i talk fast and shout more i feel i want to do everything at once i am very alert on it and learn anything very quickly and i feel i am not at peace in my mind with it and i feel thinner on it as i am using up all my energy by doing things more faster and if i miss adose i feel like fussing in my head.

  • Martin

    I took Seroxat for three years. The drug made me suicidal, violent and I did’nt care who I hurt. Coming off the drug was a nightmare that I thought would never end. I control my depression by myself now and would advise anyone to think twice before taking this drug. Talking to people who understand is the best medicine to take for depression.

  • ann

    I’ve been on seroxat for 14yrs, It saved my life, but now I want to come off it and I’m really scared, I’ve read lots of bad things about the withdrawl,
    By the way my sex life went from great to nil.i do not have any sexual feelings at all, my memory is like, what did i just say, sometimes i can’t finish sentences because i’ve forgotten what i’m saying. I very rarely feel any kind of emotion. I fear nothing, I could say alot more about seroxat.
    Why am i still taking it, because i’m scared to try and stop it.
    People told me if it makes me feel ok keep taking it, I just want my normal life back, i think its too late.
    Do not start taking seroxat it does take over your life.

  • Jess

    I also agree with Adrian regarding violence. I became violent too. This never happened before or after I stopped taking the drug. It ought to be banned. Extremely dangerous! Please seek professional advice if you experience any sideaffects whatsoever. It nearly ruined my life, don’t let it ruin yours.

  • Jess

    I took seroxat for about 12 months in 2003-2004 for panic attacks and depression. Seroxat stopped me feeling any sort of emmotion whatsoever. As a result I put myself into extremely dangerous situations. I also became suicidal. My doctor took about 10 minutes listening to my problems before prescribing me the drug. The only thing them mentioned was not to stop it quickly, no other side effects. I was disgusted with them. I could have killed myself if I had not had family near me and my mum hadn’t looked into the drug in more detail. I would strongly advise against Seroxat use.

  • rita merhy

    it makes me calm cool ,without to mush anger,but when i try 2 stopped many things happen in body

  • kashif farooqui

    My name is kashif and i m taking seroxat 20mg since 5 month 1.5 pills daily, inclusive 0.5 pills two time ativan 1mg plz advice the side effect my doctors in agha khan hospitan pakistan city karachi propsed this tablest and also use omeparzole 20 mg for stomach two time daily.

  • Ahmad

    Hi my name is Ahmad and I’m taking Seroxat since 10 years now three pills daily, recently I reduced the dosage to one pill daily it took me three month to reach one pill a day, my question is taking Seroxst for many years affect my body and till how long I should take it.