Is Contraceptive Pill, Rigevidon, Safe?

Is the contraceptive pill, Rigevidon, safe? Well, the MHRA seem to think so, unless, of course, they have been misquoted by the press.

I don't normally write about drugs outside of the psychiatric medication circle but this one grabbed my attention as it's from Birmingham and we can see clearly how the MHRA operate. To be honest, I'm flabbergasted at their shrug of the shoulders. I'll explain why later. First, here's the story...

Teaching assistant Fallan Kurek, 21, Tamworth, died after taking the contraceptive pill, Rigevidon and an inquest into her death has opened this morning.

According to the Birmingham Mail, "A scan revealed that Fallan had a large clot on her lung, causing the right side of her heart to become inflamed." Furthermore, her parents claim that doctors told them that she may have died as a result of taking the contraceptive pill, Rigevidon.

The shoulder shruggers, the Medicines and Healthcare products Regulatory Agency (MHRA), were contacted by the Birmingham Mail and  "insists the pill is safe and that women should continue to take it."

Wait a minute here...

Here we have parents of a dead girl who claim that doctors told them that their daughter may have died as a result of taking a drug - and the MHRA are disputing this because they claim the pill is safe?

So, let's just get this straight.

If a doctor, or doctors, file an adverse reaction report to the MHRA implicating a drug in the death of someone then the MHRA (because they are already convinced of a drug's safety) dismiss the adverse reaction? Furthermore, they go public with their opinion?

I'm somewhat baffled. Isn't the premise of the regulator to investigate adverse reaction reports impartially?

How are they being impartial in this instance with such a broad statement?

Let's take a look at the patient information leaflet (PIL) for Rigevidon, ironically hosted on the MHRA website.


The pill and thrombosis

Your chances of having a blood clot are only increased slightly by taking the Pill.

• Of 100,000 women who are not on the Pill and not pregnant, about 5 will have a blood clot in a year.
• Of 100,000 women taking a Pill such as Rigevidon, about 15 will have a blood clot in a year

So, 10 more women are more likely to develop a blood clot when taking Rigevidon, yet the MHRA claim it's "safe and that women should continue to take it."

The leaflet goes on to tell us...

Venous thrombosis

The use of any combined pill, including Rigevidon, increases a woman’s risk of developing a venous thrombosis (formation of a blood clot in vessels) compared with a woman who does not take any contraceptive pill.

Yet the MHRA claim it's "safe and that women should continue to take it."

The leaflet goes on to tell us possible side effects...

Like all medicines, Rigevidon can cause side effects, although not everybody gets them.

These side effects have been reported in women using the pill, which can occur in the first few months after starting Rigevidon, but they usually stop once your body has adjusted to the pill.

The following serious adverse events have been reported in women using combined oral contraceptives...

• Venous thromboembolism (a blood clot in vessels)
• Arterial thromboembolic disorders (the blocking of an artery)

Yet the MHRA claim it's "safe and that women should continue to take it."

Maybe the Birmingham Mail misquoted the MHRA or maybe the MHRA have now decided to ignore warnings on patient information leaflets?

I'm perplexed as to why the MHRA can claim a drug is safe and that women should continue taking it when the patient information leaflet suggests otherwise.

Rigevidon is marketed and manufactured by Hungarian pharmaceutical company, Gedeon Richter.


Bob Fiddaman.


**UPDATE**

Coroner returns narrative verdict.

http://www.birminghammail.co.uk/news/midlands-news/fallan-kurek-inquest-contraceptive-pill-10755513

MHRA: Follow-Up Rate at a Price

I've been at loggerheads with the British drug regulator, the MHRA, for many years. I saw a window of opportunity a few years ago when I was (finally) given the chance to sit with their (then) CEO, Kent Woods, to discuss the struggles patients were having when trying to withdraw from SSRi- type medications. (Notes on that meeting can be viewed here) Any such meetings with them these days would be kinda frowned upon by me - their current CEO being the former World Safety Officer for GlaxoSmithKline - Safety and GlaxoSmithKline, two words, combined, that just don't sit right with me. I don't wish to sit at the same table as him or anyone connected with GSK for that matter, well, not unless they have some sort of apology to offer me. (See here)

Some months after my meeting with Kent Woods I finally gave up communicating with the MHRA. The final correspondence between myself and Kent Woods is detailed in my book, The evidence, however, is clear: the Seroxat scandal. (US - UK) - In a nutshell, the MHRA did not agree with a US Court's findings that Seroxat, known as Paxil in the US, is a tearatogen (an agent or factor that causes malformation of an embryo.)

From time to time I still send in Freedom of Information requests to the MHRA, it's all very formal, no name-calling or accusations that they are limp-wristed and incompetent.

A recent request sent in to them has been going back-and-forth - apparently my wording confused them in an original request of mine so I had to wait almost two months for their reply.

My question was, I thought, pretty straight forward but I amended it for their ease.

Please provide total number of yellow cards and total number of full investigations into the alleged adverse reaction for the following years... 2011 to date (where full investigation = how many of the affected persons, or the affected persons health care professionals, did the MHRA contact to see what happened to them or to discuss with them the adverse drug reaction)

Basically, I want to see if the MHRA ever contact any person who sends in a report of an adverse reaction, after all, the patient is the one suffering here.

It's worthy to note also that the MHRA list the number of reports sent in by patients, healthcare professionals on their website. They will list, for example, the number of reported fatalities sent in via their yellow card reporting system but, and here's the crunch, they don't provide information as to whether their team of investigators have actually discussed the adverse reaction with the patient or doctor. They also claim that just because xxx fatalities have been reported with drugs x,y and z, it does not necessarily mean that drugs x,y and z caused the deaths. How, then, can they know for sure that, for example, a suicide has been caused by a drug? Leaving the public, and doctors, second guessing just adds to the woeful way the Yellow Card Reporting System is run.

Anyway, here is their reply - looks like I need to pay money up front - £600 (minimum)

So, let's just get this straight. Me (a patient) is asking for information that, I feel, is important - in as much that I wish to try and find out if the MHRA investigative team actually respond to patients or doctors on a personal level. An example here would be a yellow-card report sent in by the family of a suicide victim, or indeed the victim's doctor - I just want to know if the MHRA would, during their investigation, contact the family to ask questions about their loved one taking his/her life and if this victim displayed suicidal thinking before he/she had taken the drug.

It seems the MHRA are avoiding the question and putting other excuses in place. (Just an opinion of mine so no need to label me vexatious)

• It is important to note that each report is different and not every report requires follow up. 
• Some reporters request they do not wish to be contacted again by the MHRA 
• The MHRA determine which cases should be followed up, on a case by case basis. 

I understand that my request would take up many man hours so I sent back the following to them. It's short and sweet and yet, my lack of confidence in the MHRA tells me that they may further stonewall me with their next reply.

Dear MHRA,

I'm somewhat bemused by your answer but, I guess, I will have to take it on trust that you are not trying to pull the wool over my eyes.

Simple question as a follow-up to your reply...

Do the MHRA actually follow up any Yellow Card Report sent in by the original reporter, ie; do they,or have they, ever contacted the patient who sent in the original yellow card?

This simple question, one would think, could be answered in the blink of an eye. However, it appears that I may now have to wait a further 21 working days for a reply that I suspect will be decorated with bricks and mortar.

I hope they prove me wrong.

That will be a first!

It's simple. How many reports have the MHRA followed up by speaking with the original reporter?

I'd draw a picture for them but art was never really my thing, I draw horses that resemble hedgehogs and even my stick-men have deformities.

If the answer to the question embarrasses the MHRA, ie they don't ever follow-up with the original reporter, then why don't they just say so instead of, seemingly, putting up these stonewalls?



Bob Fiddaman

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

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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

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Rxisky Business - The Importance of Being Earnest

I've always wanted to use film titles as a title for a post, the above, Rxisky Business - The Importance of Being Earnest, kills two birds with one stone and, if I say so myself, is pleasing on the eye.

So, what am I trying to say here and why have I misspelled the word 'Risky'?

Well, this post is about the importance of filing adverse reactions to prescription drugs on RXISK.ORG, a reporting system with a difference in as much that they actually follow through the reports you send to them.

So, why report to RXISK opposed to the FDA, MHRA, TGA or Medsafe?

Paxil Behind the Closed Doors of the FDA

"We have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer."

Adverse reactions to Paxil [also known as Seroxat and Aropax]] reported to the FDA - June 2011 [Source]


Whilst reading through the adverse reactions, such as death, birth defects, withdrawal problems and hostility,  please remember the mission statement of the company that manufacture and promote Paxil.

GlaxoSmithKline Mission Statement:

"We have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer."


7580479 PAXIL
29-Jun-11
Female
Abortion Induced, Anencephaly, Drug Exposure During Pregnancy

7577731 PAXIL
28-Jun-11
Male
Congenital Anomaly, Drug Exposure During Pregnancy, Heart Disease Congenital, Kidney Malformation, Maternal Drugs Affecting Foetus, Pulmonary Malformation

7578105 PAROXETINE HYDROCHLORIDE
28-Jun-11
Male
Drug Dependence, Drug Ineffective, Hypertension, Intentional Drug Misuse, Suicide Attempt, Tachycardia, Withdrawal Syndrome

7578229 PAXIL
28-Jun-11
Female
Aggression, Drug Withdrawal Syndrome, Dyskinesia

7591796 PAROXETINE HYDROCHLORIDE
27-Jun-11
Death Neonatal, Maternal Death Affecting Foetus

7568358 PAROXETINE HCL
23-Jun-11
50
Female
Psychotic Disorder

7568362 PAXIL
23-Jun-11
Female
Drug Exposure During Pregnancy, Heart Disease Congenital, Pulmonary Artery Stenosis Congenital

7563384 PAXIL
22-Jun-11
Male
Coarctation Of The Aorta, Drug Exposure During Pregnancy

7560179 PAXIL
21-Jun-11
Female
Tachycardia

7577533 PAROXETINE HCL
21-Jun-11
80
Female
Depressed Level Of Consciousness, Disorientation, Drug Interaction, Incoherent, Respiratory Depression, Somnolence

7554502 PAXIL
17-Jun-11
75
Male
Parkinsonism

7555056 PAROXETINE HCL
17-Jun-11
Male
Abdominal Pain Upper, Agitation, Asthenia, Blood Pressure Increased, Chest Discomfort, Decreased Appetite, Depressed Mood, Depression, Dizziness, Drug Dependence, Drug Ineffective, Drug Withdrawal Syndrome, Dyspnoea, Fear, Hyperhidrosis, Impulsive Behaviour, Insomnia, Nausea, Paraesthesia, Suicide Attempt, Tachycardia, Tinnitus, Tremor, Vertigo

7560642 PAROXETINE HCL
17-Jun-11
Male
Obsessive Thoughts, Panic Attack, Product Substitution Issue

7551759 PAXIL
16-Jun-11
54
Male
Abnormal Behaviour, Mood Altered, Thinking Abnormal

7541988 PAROXETINE HCL
13-Jun-11
56
Female
Grand Mal Convulsion, Loss Of Consciousness, Syncope

7542630 PAROXETINE HCL
13-Jun-11
Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Feeding Disorder Neonatal, Hypotonia, Respiratory Distress

7561055 PAROXETINE HCL
11-Jun-11
33 Male
Aggression, Drug Abuse

7571367 PAROXETINE HCL
11-Jun-11
33
Male
Aggression, Drug Abuse

7540512 PAXIL
10-Jun-11
Female
Arnold-chiari Malformation, Atrial Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy

7540539 PAROXETINE HCL
10-Jun-11
Female
Agoraphobia, Amnesia, Claustrophobia, Dependence, Drug Ineffective, Fatigue, Feeling Abnormal, General Physical Health Deterioration, Headache, Hypoglycaemia, Malaise, Muscle Twitching, Nausea, Psychomotor Hyperactivity, Suicidal Ideation, Teeth Brittle, Thinking Abnormal, Vision Blurred, Weight Decreased, Withdrawal Syndrome

7540560 PAXIL
10-Jun-11
75
Male
Parkinsonism

7540563 PAXIL
10-Jun-11
Completed Suicide

7545129 PAROXETINE HCL
10-Jun-11
Female
Decreased Appetite, Economic Problem, Inappropriate Schedule Of Drug Administration, Mania

7536690 PAXIL CR
09-Jun-11
Female
Drug Exposure During Pregnancy, Fallot's Tetralogy, Lung Disorder, Patent Ductus Arteriosus

7536696 PAXIL
09-Jun-11
Male
Drug Exposure During Pregnancy, Pneumomediastinum

7536704 PAXIL CR
09-Jun-11
Female
Atrial Septal Defect, Drug Exposure During Pregnancy, Pulmonary Artery Stenosis Congenital, Transposition Of The Great Vessels, Ventricular Septal Defect

7556669 PAROXETINE HYDROCHLORIDE
09-Jun-11
55
Male
Drug Interaction, Loss Of Consciousness, Pulse Absent, Syncope, Torsade De Pointes

7532673 PAXIL
08-Jun-11
Female
Anhedonia, Autophobia, Brain Injury, Decreased Activity, Depression, Educational Problem, Emotional Disorder, Ill-defined Disorder, Intentional Self-injury, Myocardial Infarction, Palpitations, Product Quality Issue, Psychiatric Symptom, Scar, Suicide Attempt

7532705 PAROXETINE HCL
08-Jun-11
Female
Aggression, Autophobia, Depression, Drug Ineffective, Intentional Self-injury, Palpitations, Product Quality Issue, Suicide Attempt

7532705 PAXIL
08-Jun-11
Female
Aggression, Autophobia, Depression, Drug Ineffective, Intentional Self-injury, Palpitations, Product Quality Issue, Suicide Attempt

7532750 PAXIL
08-Jun-11
Female
Atrial Septal Defect, Drug Exposure During Pregnancy, Patent Ductus Arteriosus

7532755 PAXIL
08-Jun-11
Male
Atrial Septal Defect, Coarctation Of The Aorta, Drug Exposure During Pregnancy, Patent Ductus Arteriosus, Ventricular Septal Defect

7532757 PAXIL
08-Jun-11
Female
Atrial Septal Defect, Cardiac Murmur, Drug Exposure During Pregnancy

7532791 PAXIL
08-Jun-11
Aggression, Personality Disorder

7529403 PAXIL
07-Jun-11
Female
Cardiac Malposition, Drug Exposure During Pregnancy, Fallot's Tetralogy, Maternal Drugs Affecting Foetus, Pulmonary Artery Stenosis Congenital, Right Ventricular Hypertrophy, Ventricular Septal Defect

7529710 PAROXETINE HCL
07-Jun-11
Female
Abnormal Dreams, Abortion Induced, Amnesia, Anger, Antisocial Behaviour, Cold Sweat, Depressed Mood, Depression, Drug Exposure During Pregnancy, Headache, Hyperhidrosis, Malaise, Nervousness, Panic Attack, Paraesthesia, Recurring Skin Boils, Self-injurious Ideation, Suicidal Ideation, Therapy Cessation, Tremor, Vertigo, Withdrawal Syndrome

7545472 PAROXETINE HYDROCHLORIDE
06-Jun-11
42
Female
Coma, Self Injurious Behaviour

7523387 PAXIL
03-Jun-11
Ulcer Haemorrhage

7519659 PAXIL
02-Jun-11
Male
Parkinsonism

7535819 PAROXETINE HCL
02-Jun-11
Female
Confusional State, Disorientation

7536981 PAROXETINE HCL
02-Jun-11
32
Male Dysarthria, Hypotension, Multiple Drug Overdose Intentional, Respiratory Depression, Suicide Attempt, Tachycardia, Vomiting

7515898 PAROXETINE HYDROCHLORIDE
01-Jun-11
30
Female
Anxiety, Drug Prescribing Error, Incorrect Storage Of Drug, Panic Attack, Withdrawal Syndrome

7515898 PAXIL
01-Jun-11
30
Female
Anxiety, Drug Prescribing Error, Incorrect Storage Of Drug, Panic Attack, Withdrawal Syndrome

7540521 PAXIL
01-Jun-11
83
Female
Blindness Unilateral, Eye Haemorrhage, Reading Disorder

7563268 PAXIL
01-Jun-11
49
Male
Balance Disorder, Cerebrovascular Accident, Chest Pain, Emotional Disorder, Hypoaesthesia, Psychotic Disorder

7563399 PAXIL
01-Jun-11
90
Male
Food Aversion, Hallucination, Refusal Of Treatment By Patient


Here's the British drug regulator, the MHRA, and former GlaxoSmithKline spokesperson, Alistair Benbow, telling millions of UK viewers how safe Seroxat [Paxil] is.

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

MHRA Come Under Fire From Lancet Editor

 "The operating principle of the MHRA seems to be to do nothing until something goes wrong." -  Richard Horton  The Lancet.

Far be it for anyone to criticize the failure of the UK medicines regulatory agency...they may be labelled vexatious - However, this does not seem to have deterred the editor of The Lancet, Richard Horton.

In an article published in today's Independent, Horton states, "The operating principle of the MHRA seems to be to do nothing until something goes wrong."


His scathing attack comes after Health Secretary, Andrew Lansley, announced last week that there was to be a review of the regulation of medical devices.

Don't hold your breath folks, the MHRA have been criticized for years, they are still in place, still safeguarding human health by monitoring drugs, such as suicidal Seroxat and devices such as substandard breast implants, both of which they were warned about, both of which they did nothing about.

I echo what Richard Horton said although I'd add that even when they [MHRA] do realize something is wrong...they do nothing about it, apart from hold safety reviews with panels of industry-tied relics who tout that benefits outweigh risks...without actually ever trying out the products they review.

The scathing attack from the editor of The Lancet can be seen in full HERE.

Incidently, two questions tabled in parliament today which the MHRA have fence sat on for many years:

Eric Ollerenshaw (Lancaster and Fleetwood): To ask the Secretary of State for Health, what warnings his Department has issued on possible teratogenic effects of the use of benzodiazepines; when such warnings were issued; and on what scientific evidence they were based. 

 and

Eric Ollerenshaw (Lancaster and Fleetwood): To ask the Secretary of State for Health, whether his Department has assessed Seroxat [paroxetine] as being teratogenic. 

I fully anticipate that  the Secretary of State for Health shall contact the MHRA and be given the runaround in his search for the truth.

In the meantime, here's some more evidence of the British regulatory agency causing annoyance. [vexatious].




Another Boob From the MHRA

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA In Buck-Passing Specialist Cahoots

MHRA - More on the Mysterious "Ghost Specialists"

MHRA Wishing To Call The Shots



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ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE


AUSTRALIAN ORDERS HERE

Tamiflu: Yet More Side-Effects

It's being reported that the swine-flu drug, Tamiflu, is under scrutiny as more and more side-effects have been reported to the MHRA. The Daily Star is claiming that 14 new adverse reactions were added to the drug’s profile in November including back, joint and muscle aches, fever, menstrual pain, herpes, sinusitis and earache.

A small price to pay to fend off a killer virus, which was basically a different strain of the flu.

The MHRA, the agency that regulate the drugs you and I take, have claimed that the benefits of taking Tamiflu outweigh any risks, a standard response when their regulation is put into question.

Swiss pharmaceutical giant Roche, who manufacture Tamiflu, are themselves the subject of an investigation regarding claims that they withheld vital data about the effectiveness of Tamiflu from scientists.

The Cochrane Collaboration, an independent watchdog who are not funded by the pharmaceutical industry [unlike the MHRA] have announced that a report, to be published on January 18 shows how their investigation was hindered by Roche’s refusal to provide full clinical data. The Bureau of Investigative Journalism writes:

This claim was made public today by one of the founders of the Cochrane Collaboration at a British Medical Journal conference held in London.

 Other Cochrane reviewers are to reassert this claim in a further article due to be published by the Public Library of Science (PLoS). In the article, three of the Cochrane reviewers write:

‘In December 2009, after we voiced serious concerns in the BMJ about Tamiflu’s alleged ability to reduce compliations, Roche wrote that it was ‘very happy to have its data reviewed by the appropriate authority or individuals’ and publicly pledged to release 10 ‘full study reports’ in the ‘coming days’”. They went on to state that “despite extensive correspondence over the next year and a half Roche refused to provide any more than portions of the clinical study reports.’

The MHRA were recently in the news for failing to respond quickly enough to faulty PIP breast implants. They have also been criticised for sending out information to UK healthcare professionals regarding SSRi withdrawal and, it appears, have informed doctor's of the existence of SSRi withdrawal "specialists" when no such specialists actually exist. [LINK]



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE

MHRA Described As "Toothless Watchdog"

MHRA described as "toothless watchdog"

Today's Mail Online is running with an article which describes the British drug regulator as a "toothless watchdog."

The article refers, in the main, to the MHRA's lack of response regarding the silicone breast implant ruptures, a story which I highlighted HERE on the 2nd January.

John Naish's brilliant piece highlights the incompetence of a regulator put into place to help protect the public and it's refreshing to see a journalist raising their past failings.

Naish writes:

Sadly, this is not the first time the agency has been criticised for acting slowly and ineffectually.

In September 2010, for instance, the diabetes drug Avandia was finally banned in Britain after the European Medicines Agency ruled there was a serious risk it could lead to heart attacks or stroke.

Evidence against Avandia had been building since 2007.

And, while denying it had failed to reveal the risks when they showed up, in July 2010 the drug’s maker, GlaxoSmithKline, reportedly paid out £304 million in damages to settle about 10,000 patient lawsuits in the U.S.

However, in the same month an advisory body to the MHRA warned it that the ‘risks (of Avandia) outweigh its benefits, that it no longer has a place on the UK market’ and called for prompt action.

The MHRA did not reveal this warning to the public; it simply passed its information on to European authorities. A few years earlier, media pressure was required to force the MHRA to act over another prescribed-drug danger. Again, it was a GlaxoSmithKline medicine — the antidepressant Seroxat.

Specialists had been warning for years of the raised risk of suicide in children. But the MHRA, relying on evidence from the manufacturer, issued assurances that there was no suicide link.

AMEN BROTHER NAISH!

On the subject of the Seroxat debacle the MHRA claimed, "...it wanted to require drug makers to share more information about clinical trials — but admitted that, without stronger legislation in place, there was no chance of prosecuting the company for what it called an ‘ethical lapse’."




lapse
noun  
A temporary failure of concentration, memory, or judgment.

Glaxo must have been victims of their own product as concentration, memory and judgement are all impaired when taking Seroxat...that's probably why kids have killed themselves whilst taking it!

For the MHRA to even suggest that the suppression of clinical trial evidence was just a lapse smacks of a body of ancient freemasonary types whose fingers are either in the pharmaceutical pie or who are just too scared to speak up against the very same industry that fund them.

It's fair to say that I'm not one of the MHRA's biggest fans, nor they mine. In my book, The evidence, however, is clear, the Seroxat scandal, I write about my past correspondence with the MHRA Chairman, Kent Woods and his failure to accept that Seroxat is a known teratogen. Evidence supplied to the MHRA [taken from disclosure in the Kilker v GlaxoSmithKline trial] failed to alter their stance on whether Seroxat was a proven teratogen.

This from the Kilker trial: 

Doctor Sloot's paper demonstrated that Paxil [Seroxat] was a clear teratogen, that it was not just an effect of developmental or birth-weight related effect, that it was a direct teratogen, and that there was a spectrum of defects observed in rat embryos at low doses, establishing that it was a very potent teratogen, more teratogenic than cocaine and retinol, clear teratogens in their own right.

Furthermore, the MHRA have recently sent out an SSRi Learning Module to healthcare professionals in the UK. They have recommended to doctor's that any patient suffering severe SSRi withdrawal should be referred to a 'specialist'. On asking the MHRA exactly who these 'specialists'' were, they could not answer me. Further probing resulted in the MHRA telling me that they would not answer any more questions on the subject.

Boo Hoo!

In truth, these 'specialists' don't exist and it appears the MHRA have shot themselves in the foot by suggesting that they do.

I've labelled the MHRA 'limp-wristed' in the past, 'toothless watchdog' seems so much better.

Read John Naish's article in full HERE

Related:


Another Boob From the MHRA

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA In Buck-Passing Specialist Cahoots

MHRA - More on the Mysterious "Ghost Specialists"

MHRA Wishing To Call The Shots



Fid


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE


AUSTRALIAN ORDERS HERE

Q: Is It Safe To Take Actos? A: "Talk To Your Doctor"

With the MHRA recently rolling out their SSRi Learning Module [Links at bottom of post] and once again buck-passing the emphasis of safety onto healthcare professionals and pretend "specialists" it got me thinking why the MHRA would do something like this.

They refuse to debate with me any more about the fake specialists they conjured out of thin air so, once again, they wish to play by their rules. Sorry guys, that just does not happen in my world.

In the news recently is the Diabetes type 2 drug, Actos.

Actos is manufactured by Japanese pharmaceutical giants Takeda Pharmaceuticals and was seen as a direct competitor to GlaxoSmithKline's diabetes drug Avandia.

Avandia was shelved after it was learned that patients taking it increased their chances of having a stroke and heart attacks. This was known for some time but nobody did anything about it. GlaxoSmithKline, after years of denial, eventually paid out settlements to those harmed by Avandia.

Actos has been reviewed by the European Medicines Agency [EMA]. After reviewing recent data as well as old data they found that there is an increased risk of bladder cancer in patients who take the drug longer than a year.

How do the MHRA respond to the findings?

Advice for patients Patients should not stop taking pioglitazone without consulting their doctor. Patients receiving pioglitazone should immediately report any visible blood in their urine or bladder problems such as pain while urinating or urgency to urinate, to their doctor. Patients receiving pioglitazone will have their treatments evaluated by their doctor at their next scheduled appointment. [LINK]

Were British doctor's privy to the investigation carried out by the EMA? Nup.

Of course, many British healthcare professionals will play down the bladder cancer risk in Actos because they won't want to alarm those patients already on it. Well, they need to and the MHRA should make sure that they do and not just send out warnings, many of which will probably find the bin in the doctor's office.

It's not enough to send out a warning letter. They should be warning the patients taking it and not those prescribing it. A full-page advertisement in the mainstream media papers and a series of radio and TV commercials warning of the dangers would be a start. Alas, the MHRA much prefer to campaign about buying fake drugs over the Internet. A series of cinema and TV commercials saw them team up with pharma giants Pfizer to promote that particular safety issue - so why not do the same with Actos?

MHRA's Promotional Push About Fake Drugs - Made in Conjunction With Pfizer

I'd want to know if the drug I was taking could cause me bladder cancer, I wouldn't want to wait for a doctor to tell me. Although it would come as a complete shock to read about it in a full page advert or see it on TV, it would, at the very least give me the choice to stop taking it. In all honesty I'd sooner pull a rat out of my mouth then be told news that the prescribed medicine I was taking had caused my bladder cancer!

At the start of the year California lawyers Baum, Hedlund, Aristei & Goldman, P.C filed a lawsuit in the Los Angeles on behalf of three couples whose lives have been turned upside down due to taking a drug that should have made their lives more comfortable.

The 12 point cause of actions include failure to warn, defective design and civil code violations. It's also alleged that Takeda Pharmaceuticals knew about the bladder cancer risk but concealed that information from the public. I doubt if a lawsuit will be launched here in the UK, going up against the pharmaceutical industry here one has to overcome many hurdles.

The MHRA won't help if you have been harmed from a drug, in fact, they seem to do everything but help. The on-going Seroxat litigation here in the UK is evidence of that - one only has to look at GlaxoSmithKline's expert witnesses in that case, one being an ex-employee of the MHRA.

So folks, always remember to take your medication, if you feel that you are having trouble with it or that your bladder cancer, heart strokes or suicidal thoughts may be a result of the drug you are taking then you could always talk to your doctor about it. The very same doctor that prescribed it to you in the first place!

More about the Actos bladder cancer link HERE


Related:

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I 


MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip" 


MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine


MHRA In Buck-Passing Specialist Cahoots


MHRA - More on the Mysterious "Ghost Specialists"


MHRA Wishing To Call The Shots


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE


AUSTRALIAN ORDERS HERE

Another Boob From the MHRA

2012 sees the MHRA bowing to public pressure [once again], this time over breast implants.

For years they have fence sat [unsurprisingly] with regard to the safety of breast implants made in France  and filled with gel meant for mattresses.

Figures suggest that the MHRA have downplayed the chance of rupture with the implants, in fact, down played by as much as eight times!

Today's Mail Online reports that silicone leaks from the implants are causing agonising pain as well as swelling and lumps under the armpits. Fears have also been relayed that the implants may increase the risk of cancer.

The Mail online writes:

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has been accused of playing down the dangers. Over the last fortnight it has repeatedly urged women not to panic, simply saying that anyone who was worried should contact her surgeon. While it banned further use of the implants, it said that there was only a 1 per cent chance of rupture, compared with a 5 per cent rate reported in France.

But on Friday night the MHRA received new data from one of Britain’s biggest chains of plastic surgery clinics. This placed the rupture rate at around 8 per cent, although it was not clear if the figure applied to patients or to individual implants.

The MHRA have recently slammed the door closed on a line of questioning I put to them regarding apparent SSRi withdrawal "specialists" that they claim exist in the UK. Upon asking them for the names of these "specialists" they, more or less, stonewalled me and told me that they would not answer any more of my questions on the subject.

No problem, I can still speculate, can't I?

I'm left wondering if the MHRA only act when reports of dodgy medical devices, drugs and/or vaccines hit the mainstream press. Their house was supposedly put in order when BBC's Shelley Jofre exposed them in a Panorama documentary and it was only with mounting public pressure that they investigated GlaxoSmithKline for suppressing clinical trial evidence relating to Seroxat - the findings of that investigation were what we already knew, the action taken by the MHRA was to send GlaxoSmithKline's, then CEO, JP Garnier, a "You've been a naughty boy, don't do it again" type of letter.

So, now it appears that the MHRA have received "new data" regarding the breast implant debacle.

One has to ask why the British drug regulator are, seemingly, always last to hear about the dangers of drugs or devices. An agency put in place to monitor the safety of drugs/devices should not only be alert, they should also alert the people they were put in place to protect. The post-marketing surveillance team at the MHRA are clearly unable to do their job...it's left to the British press and/or bloggers to give the MHRA the proverbial kick up the backside.

They are supposed to be a watchdog, I think pharmaceutical lapdog would be a more appropriate term.

Related:


MHRA Wishing To Call The Shots







Fid


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE


AUSTRALIAN ORDERS HERE

GlaxoSmithKline's Cervarix Under The Spotlight [Again]

Fresh from paying off a recent fine of $3 billion for illegally marketing it's brand of drugs, Paxil, Wellbutrin and Avandia, pharmaceutical giants, GlaxoSmithKline, were yesterday embroiled in another tale of woe regarding another of their products.

This time it's their widely promoted safe vaccine for teenage girls, Cervarix.

Many of the British newspapers are covering the story of Lucy Hinks who, at the age of just 13, has been left in a "waking coma" after suffering suspected side effects from the Cervarix vaccine.

Glaxo, in usual style, have rolled out the tired and trusted one-liners that has stood them firm for years when defending drugs such as Avandia and Seroxat.

This from MSN News:

"It [Cervarix] has been shown to be generally well tolerated".

and the old faithfull:

"...we take these reports very seriously."


Ring any bells?

2002 [BBC] GlaxoSmithKline spokesperson Alastair Benbow defending Seroxat with:

"Seroxat is an effective and generally well tolerated treatment for the management of depression."

Or

"We take the safety of our medicines extremely seriously." - Transcript GSK Tape – Panorama Interview – Dr Alastair Benbow 9 October 2002


Personally, I think the comments from GSK spokespersons are being generally well tolerated by the British public, be nice if we had some transparency occasionally, doncha think?

In June 2008 a promotional DVD was sent to every G.P in the UK just hours before the launch of the Cervarix vaccine in the UK. The DVD was posted with the G.P. magazine and was a clever marketing strategy aimed at busy G.P.'s to 'brainwash' them into believing that the Cervarix vaccine protected young women from the perils of cervical cancer.

The comments at the start of this video juxtapose the claims made by GSK in the promotional video.



For more information:

http://sanevax.org/ 
http://www.americanchronicle.com
http://vactruth.com/

Warnings, Studies and Adverse Reactions on Psychiatric Drugs Database

Here's what the pharmaceutical companies and medicine health regulators won't tell you. Your prescribing doctor may not tell you either, because he/she could be as misinformed as you.

Check out the CCHR database. If you don't like what you find, tell your doctor and/or medicines regulator.

Seek the truth and don't buy into the spin that people actually need these drugs and it's dangerous to suggest otherwise.

Database HERE

Alternatively, you could contact the FDA, MHRA, Health Canada or the TGA, the "independent" bodies of drug regulators who all claim that the benefit of taking these drugs outweigh the risks...risks that include:

Suicidal thoughts
Actual suicide
Homicidal thoughts
Actual homicide
Horrific withdrawal problems
Akathesia
Long term brain damage

Choice is yours...always remember that.


Fid 


ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING 


AUSTRALIAN ORDERS HERE

Mounting Fears Over Adverse Drug Reactions

When Sky News run with a headline like this, one has to sit up and take notice.

I hope the MHRA have televisions in their offices.

Gamal Fahnbulleh, Sky News reporter, writes:

Scientists have written to the Prime Minister and Health Secretary Andrew Lansley expressing their concern about drug failures and adverse drug reactions.

More than 10,000 people die every year from bad reactions to prescribed treatments and scientists are calling for a fresh approach.

The experts believe adverse drug reaction has reach "epidemic proportions" amid rising costs in prescriptions.

Drug testing on animals before they are used on humans is being partly blamed.

Nice quote from the MHRA is also included in the article:

A spokesman from the regulatory body Medicines and Healthcare products Regulatory Agency said: "The use of non-animal testing has been extended wherever possible and the MHRA will continue to encourage this approach.

"It is very important to recognise that at present there are no laboratory methods available to totally replace animal testing of medicines."

It doesn't take Albert Einstein to work out that patients taking these drugs are actually in the fourth phase of the clinical trial. We are basically lab rats folks - one only has to pick up a telephone and ask the likes of GSK what the results were for people who had been on Seroxat for 5 years plus. They don't know, they never studied long term use - it's patients that take Glaxo's drug that are part of that long term study - this, after it has already been granted a licence by the MHRA, the same body of people who profess to safeguard human health! Incidently, the head of licensing at the MHRA is Ian Hudson, he is the former World Safety Officer at SmithKline Beecham [Now GSK] - Smell a lab rat, anyone?

Anyway, I get bored writing about the MHRA, pointless having a regulator who can't/won't regulate.

Benefits outweigh risks? Yeh, right they do!

FULL ARTICLE HERE

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

US/CANADA COPIES HERE 
UK/IRELAND FROM CHIPMUNKA PUBLISHING