Millie Kieve's Adverse Psychiatric Reactions APRIL_charity blog
Adverse drug reactions (ADRs) caused by everyday medicines, or anaesthetics can include depression, anxiety, insomnia, suicidal feelings. Pharmaceutical drugs for pain, infections, acne, anxiety, depression, may cause immediate or withdrawal reactions. Genetic differences may put individuals at risk Refer to our updated web site: www.april.org.uk for extensive information, Please follow us on Twitter @APRIL_charity APRIL (Adverse Psychiatric Reactions Information Link) www.april.org.uk

AVOIDABLE DEATHS DUE TO MEDICINES ADVERSE SIDE-EFFECTS AND WITHDRAWAL REACTIONS.

May 2019

The UK Royal College of Psychiatrists have finally agreed, after years of denial.

Withdrawal from antidepressants and benzodiazepine drugs at last being recognised as sometimes causing serious adverse effects harming many people.

National clinical guidelines are currently being updated.

Wendy Burn, president of the Royal College of Psychiatrists, said she wanted to see the guidelines "more in keeping with what we're hearing from some patients - and GPs - about the range of experiences of coming off antidepressants".

The number of prescriptions for antidepressants in the UK nearly doubled between 2007 and 2017, from around 40 million to more than 82 million, a report by the College shows.

The Royal College of Psychiatrists now accepts that it has not paid enough attention to patients suffering from severe withdrawal symptoms when coming off antidepressants.

The new stance by the Royal College follows a Lancet Psychiatry paper co-authored by David Taylor, the director of pharmacy and pathology at the Maudsley Hospital in London, who has himself experienced withdrawal, describing it in a recent New Yorker article as a “strange and frightening and torturous” experience that lasted six weeks. “Although the withdrawal syndrome can be differentiated from recurrence of the underlying disorder, it might also be mistaken for recurrence, leading to long-term unnecessary medication,” reads the paper.

Despite current guidelines recommending a taper of two to four weeks, “tapers over a period of months and down to doses much lower than minimum therapeutic doses have shown greater success in reducing withdrawal symptoms”.

Back in 2014 APRIL_charity was contacted by a desperate relative, trying to convince the psychiatrists it was withdrawal causing the problems. The psychiatrists only wanted to prescribe more and more medication.

They told us:

“I was saying that it was a result of withdrawal in the end it slightly registered but they will only treat on the basis of diagnosis and relapse and it's always more medication. I think you're right it is the way they are trained. You're website is really helpful and a gem to find when such information is so valuable and rare. Thanks once again for taking the time out of your busy day and I will continue to visit your site and support where I can.”

In 2018 the headline in the British Medical Journal was:

Government must investigate rising excess deaths in England and Wales, experts warn

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k2127 (Published 11 May 2018) Cite this as: BMJ2018;361:k2127

Research experts have urged the government and MPs to investigate rising numbers of deaths in England and Wales, after new figures showed over 20 000 “excess deaths” so far in 2018.

Earlier this year an analysis of the Office for National Statistics’ data on weekly provisional deaths in England and Wales, published in The BMJ,1 found that by week seven of 2018 (ending 16 February) 10 000 more people had died than the average from the past five years.

Doctors in the dark about how medicines work
Do Doctors have to prove they know how drugs work and can recognise Adverse Drug Reactions (ADRs) before - or even after they qualify?

The newly established Prescribing Safetly Assessment has been available for medical students across the UK only for the past 3 years.
https://www.medschools.ac.uk/our-work/assessment/prescribing-safety-assessment

This is a step forward and follows the campaign 19 years ago, we participated in to persuade the General Medical Council (GMC) to re- introduce Clinical Pharmacology into the medical schools curriculum for medical education, as in the GMC guidline manual called ' Tomorrow's Doctors'.

The subject of Clinical Pharmacology and Therapeutics had been withdrawn as an essential subject for medical students in the early 90's due to the GMC preferring 'Integrated Medicine'. As one Medical Consultant friend said to me " They will learn as the coffins are driven past the surgery windows!".

Many U.S. adults take medicines that can cause depression

Details of study in Journal of American Medical Association June 2018 repeats what we at APRIL have been warning for the past 20 years.

The researchers, from the University of Illinoisat Chicago, looked at how more than 26,000 people from 2005 to 2014 used medications.

They found one third of Americans at risk of depression as a potential adverse effect. The medicines include those for acid reflux, birth control, allergies, high blood pressure, and we know of course drugs for acne and anti-malarial are also high risk for possibly causing depression and suicidal thoughts and actions..

The news of this study spread through the world but for some reason not picked up in the UK as far as we know. There is a video of interview with a doctor on ABC news

https://abcnews.go.com/GMA/Wellness/american-adults-prescription-drugs-depression-study/story?id=55846725

Regulation of medicines safety
An excellent talk by Professor John Abraham is well worth listening to

https://www.youtube.com/watch?v=0qBd4KRbXNc

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Keep your own medical records

NHS boss reveals loss of further 162 000 pieces of medical correspondence

BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j4822 (Published 17 October 2017) Cite this as: BMJ2017;359:j4822

1. Gareth Iacobucci

The loss of more than 700 000 items of NHS clinical correspondence, reported earlier this year, has been compounded after officials admitted that a further 162 000 patient files went missing over five years.
The scandal first emerged in March 2016, when it was discovered that hundreds of thousands of files, including test results and diagnoses, were misplaced between 2011 and 2016 before they were delivered to hospitals and GPs in England by NHS Shared Business Services, an agency co-owned by the Department of Health and the IT company Sopra Steria. In June this year a National Audit Office inquiry identified around 1700 cases where patients could have been harmed as a result

APRIL charity web site now back on line at www.april.org.uk

APRIL - Adverse Psychiatric Reactions Information Link

Our web site is back on line now click here to access www.april.org.uk for information about many medicines linked to neuro-psychiatric adverse reactions, support groups, articles, videos of doctor's advice, personal experiences and much more.

If you previously found the url www.april.org.uk redirected you to this blog site, that was just during the time the new web site was being created. You may need to 'clear Internet History' to access the new web site.

Please continue reviewing this APRIL charity blog from time to time for updates on latest research or news by inserting https://aprilcharity.blogspot.co.uk into the url box.

Our new web site at www.april.org.uk will continue being updated with content, so please refer back on a regular basis for added content.

Adverse Drug Reactions (ADRs) and withdrawal effects changing mood and behaviour, need to be studied and understood.

We hope the information will be valuable for doctors and prescribers and those of us who rely on them to stay well.

Informed choice is the key, as awareness saves lives.

How many more stories like the Sodium Valproate tragedy, of harm from medicines, will we have to hear before the medical profession have the kind of education we believe they are deprived of? Not only were women not informed, some prescribers played down the risks.

We all have a right to know about even so called rare adverse drug reactions (ADRs) . Who knows how rare, when less than 10% of serious ADRs are reported? (MHRA statistic)

The warnings are often overlooked by prescribers and informed choice denied to patients. The voices of those who suffer, or are bereaved, often fall on deaf ears.

APRIL, the charity that believes Awareness Saves Lives

posted by Millie Kieve
www.april.org.uk www.april.org.uk

Please donate to APRIL the charity acting on behalf of victims of adverse drug reactions

Please donate to help APRIL as we rely on supporters, friends and family
to continue our efforts to improve patient safety. http://www.charitychoice.co.uk/april

Another tragic suicide linked to acne drug Roaccutane
http://www.eadt.co.uk/news/our-happy-go-lucky-luke-changed-after-taking-acne-drug-colchester-family-say-after-son-s-suicide-1-5005927

The tragic suicide in May 2017 of 21 year old Luke Reeves is so sad and one wonders if the consultant who prescribed the drug Roaccutane (isotretinoin) was taken in by the manufacturer's claim that suicides linked to the drug are 'rare'. The need to monitor patients on some drugs know to have psychiatric adverse effects is often not followed.

isotretinoin called Accutane in the USA and Roaccutane in the UK is a drug derived from Vitamin A with known serious adverse side effects, works for some people to reduce their acne - but for others it can lead to tragic ill health, long term depression and in some cases suicide.

I just sent the following information to a journalist:

My main comment is that parents should look a the pharmaceutical company data sheet

http://www.medicines.org.uk/emc/medicine/32477

which states under the heading
4.4 Special warnings and precautions for use:

Psychiatric disorders

Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with isotretinoin (see section 4.8). Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary. However, discontinuation of isotretinoin may be insufficient to alleviate symptoms and therefore further psychiatric or psychological evaluation may be necessary

And further, what they found in the original clinical trials is nothing to go by as the clinical trials can be rigged (talks on APRIL’ Vimeo site by Dr BenGoldacre https://vimeo.com/15986864

and Prof David Healy explain how this is done! Even if they reccon 1 in 10,000 dies by suicide how many millions are given the drug and how many hundred or thousands of families lose their lovely kids. – oh and the MHRA admit less than 10% of serious ADRs (Adverse drug reactions) are reported!

The data sheet also contains the following information for istotretinoin /Ro-Accutane under the heading:

4.8 Undesirable effects

Psychiatric disorders:

Rare (≥ 1/10 000,<1 o:p="">

Very Rare (≤ 1/10 000)

Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations

Abnormal behaviour, psychotic disorder, suicidal ideation, suicide attempt, suicide

Nervous system disorders:

Common (≥1/100, <1 o:p="">

Very Rare (≤ 1/10 000)

Headache

Benign intracranial hypertension, convulsions, drowsiness, dizziness

Another tragedy I know of and was at the inquest for was Angela Lee – no report was put in about the drugs as the Coroner said she jumped under a train. I sat next to the driver who told the jury Angela ‘staggered and fell’

The poor girl was convinced Roaccutane had destroyed her skin but was put on another 3 drugs linked to suicide and none of her doctors had communicated with each other onhow to protect a vulnerable girl…her brother had contacted me 3 months prior to her tragic death and I warned him of the risk of suicide not knowing she was also on Prozac, Zopiclone and Dianette – Dianette being a drug I have spent years campaigning about.

Important to note in the manufacturers data sheet they state stopping the drug may not alleviate symptoms as many of the suicides happen after the drug is stopped. Could this be like the antidepressants another drug with serious withdrawal complications?

This information below will appear on the new APRIL web site which is still being edited:

Roaccutane
Also known as Accutane Sotoret Amnesteem Claravis
Active ingredient isotretinoin

Indication:
Severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy.
Our mission
Roaccutane is a treatment for acne that can cause serious psychiatric side effects, such as depression and suicidal ideation. APRIL would like all patients, and ideally their families, to be aware of the severe nature of these side effects before choosing or whilst taking this medication.
APRIL has been informed of many cases from people who are suffering from long-term neurological and psychological adverse effects, including suicide attempts, apparently since taking roaccutane.
This article on David Healy’s Rxisk site blog discusses the history and extent of the pharmaceutical industry protecting this drug’s existence:
https://rxisk.org/roche-and-the-perfect-circle/
“Dying to have clear skin” is a BBC documentary on the extent of Roaccutane’s adverse effects on the lives of its patients. Please watch it here:
https://www.youtube.com/watch?v=PgpYS33kMVc
Please watch the APRIL interview with Jon Medland speaking about his son, a medical student, and his subsequent mood change and suicide whilst on Roaccutane for acne: http://vimeo.com/groups/aprilcharity/videos/16759077
Psychiatric Side Effects:
Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with isotretinoin (see section 4.8). Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary. However, discontinuation of isotretinoin may be insufficient to alleviate symptoms and therefore further psychiatric or psychological evaluation may be necessary.
http://www.medicines.org.uk/emc/medicine/32486
5% of all reported ADRs to Roaccutane are psychiatric reactions including depression, suicide and attempted suicide.
Product information for Roaccutane has been amended to strengthen warnings about depression and the possibility of suicide. Doctors are advised to monitor patients for signs of depression.
Bereaved father Liam Grant, was determined to take Roche to the High Court over the death of his son, he believed was due to Roaccutane:
http://www.independent.ie/irish-news/13-years-after-my-son-died-its-great-to-get-my-day-in-court-26663138.html

Patient Warnings and Advice
All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression.
Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary. [Action taken 08/12/05 Labeling revision]
Due to the excellent research and publicity regarding Roaccutane, the Committee on Safety of Medicines in their bulletin entitled Current Problems in Pharmacovigilance Volume 24 August 1998, issued a warning to doctors headed Isotretinoin (Roaccutane)
"Product information for Roaccutane has been amended to strengthen warnings about depression and the possibility of suicide. Doctors are advised to monitor patients for signs of depression"
The results of the above research will surely save lives – APRIL will raise funds to further the excellent work which would not have taken place but for the support of a bereaved parent.
For the latest research results see the Roaccutane Action web site www.accutaneaction.com
Evidence of side effects
The UK regulator is the Medicines and Healthcare Products Regulatory Agency (MHRA) received 1,588 reports of suspected adverse events experienced by people taking the drug between licensing in 1983 and September 2006. In 38 cases, people died and 25 of those were suicide. The MHRA says the safety of Roaccutane is under constant scrutiny. In June last year an expert working group recommended patients be monitored for signs of depression.
Further information
http://www.medicines.org.uk/EMC/searchresults.aspx?term=isotretinoin&searchtype=QuickSearch
If you have suffered a psychiatric adverse reaction please report them via the Yellow Card in the UK or to the FDA

Clinical Trial Study 329 Ghostwritten by GSK - reanalysis of review of Seroxat Paxil

Restoring Study 329 - The study that disproved anti-depressants’ efficacy

A major reanalysis of the infamous clinical trial, Study 329, has shown Paroxetine (also known as Paxil or Seroxat), one of the most commonly prescribed antidepressants, to be unsafe and no more effective than a placebo.

This new assessment directly contradicts the results of the clinical trial that claimed Seroxat to be “generally well tolerated and effective”, which was sponsored by and ghostwritten for GlaxoSmithKline, despite using the same original data.

The latest paper was published under the restoring invisible and abandoned trials (RIAT) initiative, in order to re-evaluate any conclusions drawn from evidence that had previously been hidden from public view.

Published in 2001, Study 329 generated a high level of controversy from patients and doctors after lawsuits were filed stating the side-effects were much more serious than those documented in the clinical trials.

Restoring Study 329, showed Paroxetine (Seroxat or Paxil) to have no significant reduction of depressive symptoms more than a placebo or previous anti-depressants, and gave users a higher chance of psychiatric side effects.

The original study came under intense scrutiny following revelations that it was ghost written by GSK authors and not those named on the study, and the primary data was not made publically available.

The findings of Study 329, originally published in 2001, was the first double blind patient study to report the efficacy of anti-depressants on adolescents.

It has allowed Seroxat to gain widespread approval by the healthcare industry, becoming the most widely prescribed anti-depressant in the US, with over 14 billion dolllars worth of sales between 1997 and 2004.

Following a decade of public and legal pressure, GSK finally released the original data to the public, making its reanalysis possible.

These devastating results overturning the original paper may come as no surprise to many who have already suffered loss and harm from the drug. In 2012 GSK were successfully sued $3 billion for fraudulently promoting Paroxetine to the public, and hiding key data in its study, such as reclassifying suicidal acts so that they would not count in the final analysis.

To this day however, GSK remain silent on the issue and continue to promote the drug to its customers, without any attempt to acknowledge the restoration of the study.

A personal note to our readers:

As we reveal these facts about Seroxat, we do not wish to condemn all use of anti-depressants nor encourage the immediate withdrawal from the medication. It is important to obtain advice from responsible health professionals who can help to plan any reduction in drugs that may cause dependence. It is also important to inform those close to you when you plan to start, reduce or stop taking antidepressants and to obtain professional medical or support group assistance and advice.

We wish to highlight the potential dangers and risks of Paroxetine and similar medication, and let readers understand that medical information to support the drug can be unreliable or biased.

Both starting and coming off anti-depressants is a serious undertaking and we strongly advise that users seek professional medical help as well as inform either close friends or family when doing so, as it can be a tough process which needs careful monitoring and support.

Dealing with life events can cause anxiety but may not be depression. We recommend considering talking therapy, possible CBT- cognitive behavioural therapy for those who have access to these services, as these have been shown to provide beneficial reductions of depression and anxiety with fewer and less serious side effects.

Specialised bereavement counselling is also of benefit as it is more difficult for some people to express grief when blocked by drug effects.

©JBforAPRIL

Further Reading

Article on Study 329

https://www.theatlantic.com/health/archive/2015/09/paxil-safety-bmj-depression-suicide/406105/

British Medical Journal Analysis of Study 329

http://www.bmj.com/content/bmj/351/bmj.h4629.full.pdf

David Healy’s website on the controversy of Study 329

https://study329.org/

Restored Study 329

http://www.bmj.com/content/351/bmj.h4320

Original Study 329 https://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/complaint-ex2.pdf

well worth watching and hearing psychiatrist Dr Joanna Moncrieff speak at the end of the video - her comments about 'Disease Awareness' campaigns and the fact there is no scientific evidence for the promotion by the pharmaceutical industry in their campaigns of a 'chemical imbalance' as a cause of mental distress should he heard by all medical students. Together with reading her book 'The Myth of the Chemical Cure' - if on the medical curriculum we may in the future see a reduction in iatrogenic illness. That is the ill health actually caused by the treatment. The rise in iatrogenesis is a public health crisis which the Department of Health would be wise to take into account when looking at the cost of emergency admissions to hospital.

The increase in emergency admissions to A & E caused by adverse drug reactions (ADRs) was highlighted in the Imperial College review of 10 years of hospital statistics. The increase by 76.8% was the fastest increase of any cause of admission. The human and financial cost is massive.

Adverse Psychiatric Reactions Information Link

Promoting awareness of medicines that can harm mental health