Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Friday, May 17, 2013

Guest Post: Life ‘at’ and Escape ‘from’ Paroxetine Island

The hell of Aropax withdrawal

Following on from Part I [Like a Lamb to the Slaughter] of Mark's trilogy of guest posts.

This post sees Mark describe the frustrations and hardships of withdrawing from GlaxoSmithKline's Aropax, known in the UK as Seroxat and in the US and Canada as Paxil.

Life ‘at’ and Escape ‘from’ Paroxetine Island [PI]

Life at Paroxetine Island(PI) can only really  be described in hindsight and with insight once one has spent time back on the mainland and drug-free. Here are some observations:

  • On arrival at PI one has all motivation, passion, spontaneity and confidence taken away and one is given yawning, fatigue and indecisiveness 24/7 in exchange.
  • On my 1st night at PI I experienced the most real, horrific and terrifying dream of my life. It involved my death. At the time I was clueless as to what caused this.
  • Like creeping mold is to the internal walls of a house in winter so too was paroxetine to my brain. It was a slow, insidious takeover of not just my brain but also my soul. Dulling my emotions and senses, and even when the wallpaper started falling off I was clueless as to the cause.
  • My quality of life grew worse and worse, as I became more and more removed from reality.
  • Life was sucked out of me and I was no longer living I was simply existing.
  • I became a loner and yet I wasn't lonely.
  • Much time and effort was spent fighting back evil intrusive thoughts, thoughts that did not belong to me, thoughts that were extraordinarily immoral, offensive and almost audible in my mind beckoning me towards self-destructive behaviour. Thoughts that were demonic in nature.
  • Personality and behavioural changes occur on PI perhaps best described as a severing of the conscience.
  • Loss of feelings and caring occurred, a total disconnect from reality. The mantra of PI was:
  •  ‘So what, who cares’! And I was soon singing it.
  • An early attempt to break free and swim to the mainland resulted in such psychological, emotional horror and panic I rushed back to my doctor and asked to go back to PI. I was sent back no questions asked. 
  • Despite promising to never swim away again several more failed attempts to escape left me in a state of learned helplessness, a massive major paradigm shift now occurred in my being. I now believed that I needed to be on Paroxetine Island!
  • One day I learned of a person who had escaped from PI and swum back to the mainland. I became very envious, jealous even!
  • I was now determined that I too would get back to the mainland. Little did I know that I was about to start a 3-year traumatizing nightmare, a journey through ‘Hell,’ that was going to require every ounce of strength to survive, fighting for my life, daily. 

My Escape from Paroxetine Island (PI)

I would like to start by just saying that my escape from PI was the most difficult thing I've ever done in my life. No non-poisoned-by-an-SSRI-brain can conceive, imagine, or understand the traumatising nature of this ordeal.

  • I presented to my doctor in January 10, after 10 years use, wanting to get off paroxetine. His reply “okay come off slowly”, and sent me on my way. (Absolutely criminal!)
  • I had no idea what slowly was. But decided to start to alternate doses 20 mg one day and 10 mg the next.
  • After 6 months I was on 10 mg and in a distraught state.
  • The distress drove me to seek counselling, yet it offered no relief. Except lighten my wallet.
  • At 9 months and on 5 mg feeling death would be a welcome relief I reluctantly presented to my Doctor (Dr W), only to be told I had an underlying depression and I needed to up dose. At this point I realised Dr W was clueless. I replied, ‘that is not right’. He referred me to a psychiatrist Dr S.B.
  • Confused, distraught, frustrated, and in a very dark place, somehow knowing deep down something was not right here but what could it be, I confided in the neighbouring pharmacist. He leaned over and quietly whispered, “Mark I’m not supposed to tell you this but it’s not you it’s the drug”.
  • It was like a light switch was flicked, the light bulb went on, I came to my senses. Of course it’s not me, it’s the drug! It was the damn drug! How could I have been so stupid! Words cannot describe the humiliation that started to flood my being followed by anger and disbelief.
  • I immediately started digging, and stumbled upon an SSRI addict’s and survivors support group. I realised I had found a place ‘sought by millions but found by few’. I owe my life to them.
  • On asking the psychiatrist Dr S.B. if he was aware of any problems with people getting off Paroxetine  he replied, “Well if there were problems with people getting off paroxetine people would be suing the drug companies” [I was later to realize this was a Dr who clearly had his initials around the wrong way].
  • He also okay’d a Healtheries supplement I wanted to take to try to get some relief. I was sent on my way. I now realised I was on my own.
  • I broke free of PI on 28 September 2010.
  • The 9 month taper down and the next 2 years drug free was hell. The nightmare I had to suffer (believe me to call it a nightmare is an understatement) coming off this drug had nothing to do with me and everything to do with this drug!
  • I wouldn't want my worst enemy to go through this. I was unable to function experiencing daily uncontrollable restless anxiety, endless crying and drug induced suicidal ideations starting from 6 a.m. lasting throughout the day and receding somewhat in the evening. I felt as if I was being psychologically and emotionally raped daily. This withdrawal horror went on for almost 3 years, with the drug induced withdrawal hell pushing me for months to cut my wrists, then for months it tried to get me to hang myself, then it wanted me to shoot myself, and if that wasn't enough drive my car into oncoming traffic. I still remember the day I fought off an overwhelming desire to jump off a bridge.
  • These drugs are not given to patients under 18 because they cause suicide …well if my experience is anything to go by they should extend the relabeling ban to those under 50!
  • In order to get through this hell alive I dragged several family members so far into emotional overdraft I will never be able to repay them. You can forget being able to hold down a job during this ordeal it’s a battle to just survive each day.
  • I so much wanted to reinstate to take the horror away, yet I was driven by a sense of unbelievable anger and humiliation to not do so. Often chanting back ‘it’s not me it’s the drug’ when waves of hell flooded me.
  • All I wanted was an opinion on my sore arm, I never consented to this.
  • At about 18 months drug free I felt the shark infested waters start to recede, a few months later I washed ashore onto the mainland, exhausted, traumatized and in total disbelief that I was still alive.
  • I felt like Rip Van Winkle coming to after being placed in a living coma becoming acutely aware of the damage done to me, waking up in shock and disbelief.
  • Let there be no mistake about it, if I was an enemy combatant and the NZ army did this to me, someone would have been dragged to the Hague and jailed for this! 
  • Hippocratic Oath…..Yeah Right!
  • I was determined to get an explanation for this insult to my humanity an answer for something no human should have to endure.

Mark Carter NZ

Coming soon Part III

Bob Fiddaman


Friday, May 10, 2013

SSRi Withdrawal - A Lesson For Doctors

Far be it from me, a blogger, to give doctors a lesson in managing antidepressant withdrawal... but I'm going to anyway.

I've been writing this blog for 8 years now and, over this period of time, have been inundated with emails from patients struggling with withdrawal issues from their medication. Most popular question is along the lines of "How long does it take before these terrible side-effects go away?"

A good 90% of the emails start off by telling me the side effects, crying, sweating, electric-like zaps in the head, shaking, most of these conditions, if not all, appear when the patient starts to taper off the drug on the advice given by their healthcare 'professional'.

When I have told those who have contacted me about their medication being available in a liquid form they are flabbergasted. Why didn't my doctor tell me this? is the normal reply.

The liquid formulation for SSRi type medication came about as a result of pharmaceutical companies being able to persuade doctors [via their reps] that patients who had difficulty in swallowing their medication could always use the liquid. These 'patients' were the elderly and children. The liquid was never intended to be used as an aid to help people wean off the medication.

Wait a minute, these medicines aren't meant for children. Correct, but that has never stopped the pharmaceutical industry reps in their quest to boost company sales in return for that big bonus at the end of each month or quarter.

So, what about adults who have no trouble swallowing tablets? Well, the gist I'm getting from the emails I've received is that doctors tend to read the company spin on withdrawal.

Pharmaceutical companies never liked the word 'withdrawal' as it implied giving the patient a hard time so they changed it to 'discontinuation'. Doctor's when reading the product monograph for any of the SSRi's will read that 'discontinuation syndrome should only occur for around two weeks'. There is no information given to the doctor or patient about how much he/she should reduce their dosage by.

Contact the manufacturer of your particular SSRi and you are taken on a frustrating journey.

Pharmaceutical companies will tell you that they are not allowed to discuss individual patient cases and will refer you back to your healthcare professional, who remember has at his disposal the product monograph that claims 'discontinuation should only last around two weeks'.

Truth of the matter is, discontinuation/withdrawal can last months even years. Your healthcare professional won't acknowledge this because all he has to go on is what the pharmaceutical company have provided him [product monograph]

Some of the advice given by doctors that I've seen personally has ranged from the ridiculous to the sublime. Here's some:

  • Cut your tablet in half
  • Take 20mg Monday, 10mg Tuesday, 5mg Wednesday then stop.
  • Try stopping altogether at the weekend as there will be less stress in your life, ie; work, dropping the kids to school. If you still feel bad then start again on Monday.

One patient, a 17 year old, was told by his trainee psychiatrist, to stop taking his Prozac at weekends so he could enjoy up to six bottles of beer then restart again after the weekend. That patient, Toran Henry, killed himself shortly after being prescribed a generic form of Prozac [Fluox]

So, where can doctor's go for their information on antidepressant reduction?

Product Monograph [Written by the manufacturers of the drug]
Patient Information Leaflet [Written by the manufacturers of the drug]
Medicines Regulator [A body fully funded by the pharmaceutical industry]

Where do patients go?

Well, they go to the one person they can trust, their doctor. It may take a while for the patient to realise that the doctor is as clueless as they are when it comes to withdrawal help, it's then that they turn to either friends or, more commonly these days, Google.

Many patients find themselves using search terms such as 'Escitalopram aggression', 'Seroxat Brain Zaps', 'Cipramil Agitation'. The hits, when I first started this blog, were few and far between. That's when I learned that Seroxat isn't called Seroxat in the USA, it's called Paxil. Back then I Googled the words 'Paxil + Withdrawal' - I hit the jackpot. Website after website, forum after forum appeared. Stories about brain-like zaps, aggression, suicidal thinking, self-harming. The same can be said today for Cipramil and Escitalopram [both brand names for drugs known in the US as 'Celexa' and 'Lexapro' - Try a Google search yourself and you will see much more can be learned by typing in the US brand names opposed to the British/European brand names.

Even if you do find evidence that you are not alone in this withdrawal hell don't expect your healthcare professional to thank you for bringing the evidence to his/her attention. More than likely you'll be told that it was he/she who went through med school, if he/she does tell you this then ask him/her how long he spent covering SSRi withdrawal.

He/she may also tell you not to do your own research as you are either not qualified in such matters or the information on the internet about SSRi's is just conspiracy theories.

What you, as a patient, must do is TELL your doctor that you need a liquid version of your antidepressant so you can taper safely and effectively. Remember, this is YOUR body.

Tapering by using the liquid is a very slow process but it is much safer than skipping doses or drastic reductions in dosage.

You may find the taste somewhat off-putting, Glaxo's Seroxat liquid is orange flavoured and tastes like 5 cups of sugar has been added. If you can get through the bad taste then it's better than having to endure mind-bending electric jolts through your head.

Apparently the liquid formulations of SSRi's cost more, probably one of the main reasons doctors won't write scripts for them.

Remember that SSRi withdrawal is your own experience, it does not belong to your doctor or anyone else for that matter. Don't frustrate yourself because the manufacturers of your medication won't help you - that's just their way of avoiding litigation. If they acknowledge you are having a bad time on their drug then they'd have to acknowledge that other people are too - that would just open the door and they'd be flooded with personal injury lawsuits.

So, how slow do you taper once you have the liquid? As slow as you need to is the answer. I came down 0.5mg per week. [20mg dose of Seroxat = 10ml of Seroxat liquid] It took me over a year to drop from 40mg per day to 22mg per day. I then quit cold turkey - not recommended.

So, if you are a healthcare professional using Google and you have stumbled on this post then I suggest you put your BNF to one side, disregard all the pharmaceutical propaganda you have at hand, take off your God hat and start listening to patients.

The pharmaceutical industry will get richer from you, the patient, snapping up their sickly, foul-tasting liquid but at least you will be reducing the money going in their pocket. What's it to be, a slow taper or a life-time hooked on SSRi's?

At the time of writing this I'm only aware of four SSRi's that are available in liquid. Namely, Fluoxetine, Sertraline, Paroxetine and Citalopram .

Bob Fiddaman


Wednesday, May 08, 2013


This year's 4th annual PharmedOut conference is hitting town and, judging by the speaker list, looks like it's going to be the best yet.

Highlight of this year's conference, for me at least, is the 'surprise guest' from a major pharmaceutical company who is going to be talking about ethical conflicts inside the industry.

PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.

Some of their goals are:

Document and disseminate information about how pharmaceutical companies influence prescribing

Foster access to unbiased information about drugs

Encourage physicians to choose pharma-free CME

Sadly, the conference is too far for me to attend but I'm sure it will be much talked about in the future.

So, if you are a lawyer, state government official, FDA official, or work for the pharmaceutical industry then you may just want to go and listen to what these speakers have to say... however uncomfortable it may be for you. Speakers include:

Marcia Angell MD, author of The Truth About Drug Companies: How They Deceive Us and What to Do About It;  former editor-in-chief, NEJM
Virginia Barbour MD, chief editor, PLoS Medicine
Elizabeth Loder MD, editor, BMJ
Carl Elliott MD PhD, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine and Better Than Well
Charles Ornstein, Senior Editor, ProPublica
Diana Zuckerman PhD, president of the National Research Center for Women and Families
A ghostwriter describing how he helped sell Low Testosterone Syndrome (“Low-T”)

You can register for the conference here.

Event start date: June 6, 2013 8:00 AM
Event end date: June 7, 2013 5:00 PM
Location: Georgetown University
Questions? Call: 202-687-1191


Bob Fiddaman


Monday, May 06, 2013

Sara Carlin - 6 Years On

18 year old Sara Carlin

Today [May 6] marks the 6 year anniversary of the death of Oakville teen, Sara Carlin.

Sara tragically took her life back in 2007 and her much publicized 2010 inquest saw her parents, Neil and Rhonda, face teams of lawyers representing doctors and GlaxoSmithKline.

Sara had, around a year or so prior to her death, been prescribed Glaxo's Paxil [paroxetine], a drug that is infamous for inducing suicide, particularly in children and adolescents.

Sara was just 18.

The inquest, that I labelled the Glaxo & Friends Vs The Carlin Family, rolled out apparent SSRi experts who made various claims that 'suicide is much more strongly related to cases of untreated depression' and in any event Paxil induced suicide is more common when first starting the drug.

Oh really?

Sara had missed her dose for three to four days leading up to her suicide. This was disregarded by the experts because "the information provided did not suggest that Ms Carlin suffered from the usual triad of symptoms seen with withdrawal" - Oh really?

Completed suicide is a symptom of withdrawal. There is no greater suffering than death Mr Expert Man!

Anyway, Sara's story went global and many, myself included, believe that her suicide was brought on by Paxil. Yes there were other factors, all of which were used by lawyers representing both Glaxo and doctors during the inquest. I've mentioned before how Glaxo like to blame everything but their product, Sara's inquest is a classic example of this.

We see this played out all the time in coroners courts. I don't envy anyone who has to sit through so called experts blaming the victim but softening the blow with terminology such as 'troubled youngster' or 'mentally ill'.

Coroners courts put the victim on trial and offer opportunity for people that didn't even know the victim to say how bad they was, be it through drinking, illegal drug-taking or being an uppity teen. We've seen victims of suicide bad mouthed before and after Sara's inquest, Toran Henry and Shane Clancy are two that spring to mind.

A whole heap of recommendations were made at the end of Sara's inquest. I have wrote about the word 'recommendation' before. It means nothing.

None of the recommendations made back in 2010 have been implemented.

Today my thoughts are with Neil and Rhonda

Here's a video I did for Sara back in 2010, a video that has been viewed over 13,000 times.

Nessun dorma Sara

Related Sara Carlin articles

Sara Carlin Inquest – Latest

Sara Carlin Inquest – Failure of Oakville Medical Profession

Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’

Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!

Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline

SARA CARLIN INQUEST - What The Jury Should Know

Sara Carlin Inquest - "Paxil likely played important role in teen's suicide"

Sara Carlin Inquest - The Eli Lilly 'Links' & Today's Recommendations.

**Exclusive - Sara Carlin Inquest: The Bias Of Coroner's Counsel, Michael Blain & Coroner, Bert Lauwers?

The Inquest of Sara Carlin and the Moderation of Yahoo Groups

Bob Fiddaman


Saturday, May 04, 2013

Guest Post: Like A Lamb to the Slaughter

As this blog grows I get more and more requests from readers asking if they can write a guest post. This has proved very popular and gives a chance for people, patients to vent... none more so than the author of this post, Mark Carter.

As you will learn, Mark is yet another victim of the over prescribing of psychiatric medication, another victim of off-label prescribing.

Mark's story... and this is just part 1 of 3, is nothing new. Thousands, if not millions, of unsuspecting patients are, within minutes, walking out of consultation rooms with pills that are nothing more than loaded bullets. They are being diagnosed with ailments, in Mark's case sore wrists and arms, and then prescribed drugs that have no indication to treat the diagnosis.

This is, sadly, on-going globally.

Mark is from Auckland, New Zealand.

Here's part I of his story.

Like A Lamb To The Slaughter - Part I

I have decided to do a posting for Bobs blog for the following  reasons:

1. It’s not acceptable to me, for SSRi’s  especially paroxetine [Seroxat, Paxil, Aropax] and including venlafaxine [Effexor] to continue to be on the market.

2. It is my wish that these drugs be exposed for what they truly are; toxins that disrupt and chemically damage the brain and body.

3. I feel morally obligated to communicate to the general public the dangers of these poisons , as I have been grievously injured by taking and subsequently discontinuing them,

4. A dangerous, negligent and appalling level of ignorance from doctors who have thoroughly hoodwinked patients into believing black is white, and  from whom no one has a chance of being informed of the truth.

5. I have nothing to hide only devastation to human life to expose

6. If I can stop one person from taking an SSRI or its evil cousins then its been worth it.

It all began in the summer of 2000. In December I presented to an Occupational Specialist Doctor D. with sore wrists and arms from keyboard overuse at my work site.

I was a 37 year old single, cheerful, happy, sports loving, opera chorus singing male. I had never smoked, drunk alcohol, or taken any drugs prior. I also had never had any psychological issues.

I was diagnosed with chronic pain syndrome and given what I now know to be a smorgasbord of poisons.

At the time I was like a lamb to the slaughter, naive, trusting and oblivious to oncoming danger.

I asked the right questions as anyone would, are these addictive, are there any side-effects?

I left assured they were not addictive but  may find they give me a dry mouth.

I was also assured they would heal my arm.

Arrived home that day with canisters of amitriptyline, nortriptyline, venlafaxine, and paroxetine . I was told nothing regarding tapering down or not stopping abruptly.

I never felt comfortable with the diagnosis of chronic pain syndrome. The term at the time was repetitive strain injury or occupational overuse syndrome.

I also was filled with dread at being sent back to a job that I clearly could not do any longer. I clearly had an injury in my hand in which pain and an inability to type was amplified when using a keyboard and receded when not using the keyboard.

I was told to take a course of each drug and if no benefit move onto the next one.

I was totally unaware that I was about to expose myself to some of the most dangerous addictive mind-numbing soul destroying potent body damaging chemicals ever manufactured for human consumption.

I was totally unaware of the nature or the toxic effects of venlafaxine and paroxetine.

In hindsight I felt pressured to take these drugs, I mean not taking anything was never a tabled option.

I worked my way through the drugs, on starting the venlafaxine I immediately started getting  floaters in my eyes. I was clueless. I also recall being incredibly fatigued, my walking became labored. I rang Dr D at the time from my former work site regarding  the struggle to cope and was told to double the dose. Not long after this, my employer, as I could no longer use a keyboard, fired me.

As I no longer had to bare  a workload and didn't really want to take drugs I  quit cold turkey the venlafaxine, as one would with a so-called non-addictive drug that was doing nothing except fatigue me.

What I didn't know at the time,  but I do now, is Dr D had persuaded me to take a sequence of drugs not authorized for use for my injury. He had in fact persuaded me to participate in the off-label use of the drugs and did it by obtaining my uninformed consent.

Shortly after this I started to manifest an uncontrollable anxiety, a kind of  psychological panic, a distressed tearful state. There was something clearly wrong with me and something I had never experienced before.

I was clueless as to the cause of this, and thought it may be due to some external stresses at that time.

Concerned  I now presented tearful agitated and confused to my family Doctor W of 20 years,… like a lamb to the slaughter. I can still remember my exact words at the time.

“There is something wrong with me, I don’t know what it is, you know me I’m so against the taking of drugs, but do you think I need something for this.”

Without any hesitation, enquiry or diagnostic checklist I was presented with a prescription for paroxetine 20 mg per day and sent on my way assured it was not addictive, safe and may cause a little weight gain.

And that was to be the start of a 10 year drug addiction with a sore arm somehow morphing into a drug induced 'mental illness'.

Stuck on paroxetine-Island only to be met by psychological and emotional shark infested waters every time I tried to leave.

And in addition totally unaware that I was now exposing myself to a slow chemical castration.

Mark Carter - New Zealand

Part II Coming Soon

If you would like to write a guest post then I can be contacted via the 'Contact' tab at the top of this blog.

Bob Fiddaman


Thursday, May 02, 2013

Patient Information or Litigation Disclaimer?

I was browsing through some SSRi patient information leaflets [PILs] earlier and have come to the conclusion that the manufacturers warnings about this, that and the other are merely coded messages to the consumer.

Years ago, when SSRi's first hit the market, there were few warnings of side-effects. Sure, back then we had dizziness, nausea, sweating etc but that's standard for most, if not all, prescription medicines.

Today, after US litigation, patient reporting and, it has to be said, internet activism, the PILs take on a completely different look. They [the manufacturer] are telling us we can't sue because we were told.

It's almost as if pharmaceutical compliance departments had a eureka moment and turned really bad news into something that could be productive in the future. "Hey if we stick broad but vague warning labels on our drugs then we cover ourselves from future litigation... quick, get the number for that medical ghostwriting team we used back in 1998"

Let's take a look at Seroxat for example. [NHS Information]

Motion to dismiss

1. Some people who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. 
Very vague statement but one that would certainly be used by GlaxoSmithKline attorneys if they were ever faced with a lawsuit. "There is no case for your client as my client clearly stated in the patient information leaflet that Seroxat wasn't for everyone."

2. "If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide.
"If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible."

Again, Glaxo attorneys could have a field day, "Your honour, we have reason to believe that the deceased did not contact their prescriber, yet my client clearly stated in the patient information leaflet for them to do so if they were feeling suicidal, therefore we argue that there is no merit in this case" 

 3. Seroxat is not suitable for everyone and some people should never use it.

"Your honour, if the deceased had killed themselves by touching an electrical fence despite there being a warning not to do so would my learned friends still be representing him in court?" 

4. Over time it is possible that Seroxat can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately.

"Your honour, the plaintiff may have become, over time, unsuitable for our client's product, he may also have had an adverse reaction to my client's product. At no time, leading up to his attempted suicide, did he contact his prescriber despite the fact that my client had advised this in the patient information leaflet."

5. You should only take this medicine during pregnancy if your doctor thinks that you need it
"Your honour, whilst my client has every sympathy for the birth defects the child in this case was born with, it was not my client's fault. My client never prescribed Seroxat to this young mother, it was her doctor."

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth

"Your honour, how many warnings did this mother need, was she illiterate, could she not read? My client refutes any responsibly with regard to the plaintiff's son being born with septal heart defects. In fact, my client believes that it should be the plaintiff who should be facing prosecution for acting irresponsibly."

 7. This medicine may decrease fertility in men.

"Your honour, he was warned."

8. Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

"Your honour, my client blames the plaintiff and both the doctor and midwife, they should have read the patient information leaflet."

Judge's summation - Sadly, it is with great regret that I am granting GlaxoSmithKline motion to dismiss on the grounds that they covered all bases for any future litigation by applying warnings to their patient information leaflet. I am, however, recommending that in future Glaxo elaborate on the warnings. My recommendations are underlined:

1. Some people, particularly those who are poor metabolizers, who take Seroxat may find that it intensifies depression and suicidal feelings in the early stages of treatment. GlaxoSmithKline nor your prescriber cannot tell you if you are a poor metabolizer so, in essence, by administering Seroxat you are playing solo Russian roulette.

2. If you are taking Seroxat, or you care for someone who is taking Seroxat, you need to look out for changes in behaviour that could be linked to self-harm or suicide. Changes such as an increase in depression, anxiety, an inability to sit still, a lack of empathy toward others, excruciating electric-like zaps in your head, horrific nightmares where the subject matter is death, homicide, suicide. Outbursts of anger, for no apparent reason, aimed at those you love. If you notice any of these changes or are worried about how Seroxat is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible. NHS Direct et al should then telephone a 24 hour hotline, manned by an independent body who have no financial ties to GlaxoSmithKline, and request a safe withdrawal protocol. The patient should be hospitalized, at GlaxoSmithKline's expense, and monitored at regular intervals. Any item of clothing that could be used as an instrument for suicide must also be removed. GlaxoSmithKline's CEO, Sir Andrew Witty, should be contacted, no matter what time of day or night it is. Sir Witty may then realise that bad things didn't just happen to patients under JP Garnier's watch, they are still happening and are not part of "an era". Sir Witty can sit with the patient while he/she experiences thoughts of self-harm and/or suicide. Because of the logistics and vast number of people who suffer these kind of adverse reactions to Seroxat it is recommended that Sir Witty handpicks a team of GlaxoSmithKline executives to be on emergency call to tend to the needs of Seroxat induced suicide victims.

3. Seroxat is not suitable for everyone and some people should never use it. Some people cannot excrete Seroxat from their system quicker than others. This means that they build up toxic levels of the drug, in fact these people are overdosing on Seroxat without actually knowing it. This simple fact should be made crystal clear in future patient information leaflets. Sir Witty and his handpicked team of executives should disseminate this information to the public by word of mouth. Alternatively  a full page advertisement can be used in popular mainstream newspapers to warn this vulnerable patient population. "Toxic levels of Seroxat may lead to self harm and suicidal thoughts" should also be added to the patient information leaflet.

4. Over time it is possible that Seroxat can become unsuitable for some people, particularly those who are poor metabolizers, or they may become unsuitable for it, particularly those who are poor metabolizers, If at any time it appears that Seroxat has become unsuitable, it is important that the prescriber is contacted immediately. The Prescriber should then contact GlaxoSmithKline to file an adverse reaction report. In turn GlaxoSmithKline should investigate the adverse reaction and report back to the prescriber with a causality assessment. This will then help the prescriber decide, in future consultations with patients, if Seroxat is the drug for them.

5. You should only take this medicine during pregnancy if your doctor thinks that you need it - This whole sentence needs drastic change. A doctor does not have access to the rat pup studies that GlaxoSmithKline has and kept from the public. Expectant mothers should be made aware of the Sloot study whereby Seroxat and other SSRi's were exposed to rat fetuses. Out of all the SSRi's used in this study only one came out as a clear teratogen - Seroxat. Another example of a teratogen, in case consumers are not aware of the word, is the anti-nausea and sedative drug, Thalidomide.

6. If you take this medicine during the late stages of pregnancy your baby may have some problems after birth. The sort of 'problems' are:

Persistent Pulmonary Hypertension of the Newborn (PPHN) – 6 times increased risk
Anencephaly (fatal neural tube defect) – 2.5 times increased risk
Clubfoot – 5 times increased risk
Craniosynostosis (craniofacial defect) – 2.5 times increased risk
Omphalocele (abdominal wall defect) – nearly tripled risk
Gastroschisis (abdominal wall defect) – 30 percent increased risk
Pulmonary Atresia – 3 times increased risk
Spina Bifida – 60 percent increased risk
Diaphragmatic Hernia – 80 percent increased risk
Anal and Esophagal Atresia – 30 percent increased risk
Heart Defects – nearly doubled risk
Septal Defects, including Atrial and Ventricular (also known as “hole in the heart” defects)
Hypoplastic Left/Right Heart Syndromes
Malformed or blocked heart valves that will not close
Transposition of the Great Arteries
Tetralogy of Fallot
Mitral Valve
Heart murmur

Like packets of cigarettes I make the recommendation that GlaxoSmithKline add a photograph to the packaging of Seroxat. An example is below.

Spina Bifida – 60 percent increased risk when taking Seroxat [1]

7. This medicine may decrease fertility in men. Given recommendation 6 this may not be such a bad thing, particularly if the female partner is also digesting Seroxat. Sir Witty and his team of handpicked executives may wish to visit any male patient who has decreased fertility as a result of taking Seroxat and, if requested, help to fill out some adoption forms for the wannabe father. GlaxoSmithKline shall foot the bill for the whole adoption procedure, including lawyers fees and expenses for the child up to the age of 19.

8. Before you have your baby you should discuss breast-feeding with your doctor or midwife as Seroxat can find a way into your baby when he/she breast feeds. This can cause serious implications for the newborn child and may result in Seroxat overdose, addiction, agitation and in some instances death. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. They will also offer you the court transcripts from the Kilker Vs GlaxoSmithKline birth defect trial where GlaxoSmithKline were found guilty for manufacturing a drug [Seroxat] that caused Lyam Kilker to be born with heart defects. This will  help expectant mothers to make a fully informed decision and may deter them from breast feeding given that Seroxat can harm a baby whilst it is still in the womb so chances are the baby can be harmed if ingesting breast milk that is still in the mother's system. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife and with the knowledge that your doctor or midwife actually know what they are talking about.

I make these recommendations with the knowledge that healthcare professionals and GlaxoSmithKline have the right to ignore them as do global medicine regulators and coroners. In fact, the word 'recommendation' means nothing. It just makes people like me seem as if I really care when in actual fact I'm just recommending what I think should be done but I know that the likelihood of any recommendations made simply means that nothing has to be adhered to. I'm a Judge and I have to be seen to be doing something. I use war as an example. World leaders got together to fight the might of Hitler. At some point it was only recommended that they intervene. They didn't have to but because they did they stopped Hitler, some would suggest that those recommendations to intervene should have been carried out earlier, maybe more lives would have been saved. Thing is, those recommendations were listened to, they were put into place and we are a better world for it.

I would urge for GlaxoSmithKline's CEO and handpicked executives to search their consciences but past litigation [in the US] has shown that these individuals blame everyone and everything but their product.

I would like to recommend that Seroxat is removed from the shelves but know I would face tough opposition from those who have been duped into believing that the benefits of this particular antidepressant outweigh the risks. The risks, all of them, should be printed out in clear laypersons terms, again, I can only recommend this. I do know that, after reviewing all the court documents in cases such as Seroxat induced suicide, Seroxat birth defects, Seroxat withdrawal/addiction, that I will never allow any family member of mine to take this drug. That's my privilege as I am a Judge.

Glaxo's motion to dismiss - Granted.

Rt Hon Judge I.M Pointless


Later that year the Rt Hon Judge I.M Pointless granted the same motions to Eli Lilly, Wyeth, Pfizer, Forest Labs, Lundbeck and other SSRi manufacturers, including those manufacturers that make generic versions of SSRi medication. 

He also made similar recommendations.

[1] Birth Defects Cased By Seroxat [Birth Defect Resource]

Bob Fiddaman


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