Are you feeling down or anxious? or is someone close to you causing concern due to changed behaviour?
Commonly used medicines and anaesthetics can cause psychiatric adverse drug reactions (ADRs) or withdrawal effects including: experiencing anxiety, mood swings, insomnia, nightmares, depression, agitation, self-harming, paranoia, suicidal or aggressive thoughts and actions.
APRIL (Adverse Psychiatric Reactions Information Link) is a UK charity promoting improved medical education and NHS support for those vulnerable to, or suffering from adverse drug reactions (ADRs,) dependence or withdrawal effects.
Millie Kieve's Adverse Psychiatric Reactions APRILcharity blog Adverse drug reactions (ADRs) caused by everyday medicines or anaesthetics can include depression, anxiety, insomnia, suicidal thoughts and actions and dependence.
Our web site is updated, so please refer to www.april.org.uk for extensive information, as well as reading this blog.
Please follow us on Twitter @APRIL_charity and view our videos: https://vimeo.com/user1816628.
APRIL (Adverse Psychiatric Reactions Information Link) www.april.org.uk
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
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1.The BMJ 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 - Adverse Psychiatric Reactions Information Link
Our web site is back on line now click here to access www.april.org.ukfor 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 insertinghttps://aprilcharity.blogspot.co.ukinto 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
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
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
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:
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 Evidenceof 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
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. In2012 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.
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.
Our web site is being updated Blog post - latest update 15 December 2016 You will have been re-directed to our blog while our web site is in the process of being upgraded and edited, for which we apologise. Please read here : our submission to the Parliamentary Health Select Committee Inquiry into Suicide Prevention The final report by the committee totally ignored the medication links to suicides, stating the view of those who gave oral evidence was that treatment with drugs is better than no treatment. How sad they could not discuss the fact there are suicide warnings for many psychotropic and everyday medicines. APRIL charity has had a web site for over 15 years - this is currently being upgraded. By early 2017 we should have an improved site up and running - In the meantime please read articles on this blog and view our videos from our groundbreaking conferences. Leading experts in clinical pharmacology, genetics and medical education. speak and answer questions about adverse drug reactions (ADRs), and dependence issues. Hear about the way clinical trials may be manipulated explained by Dr Ben Goldacre and Professor David Healy. The wonderful Professor Heather Ashton's wise words and many other experts in the field of medicine. A coroner's view and the stories of people, some bereaved, who kindly agreed to sharing their experiences with us. https://vimeo.com/user1816628 We also have a Youtube channel to which over 40,000 people have seen and some have commented. Well worth reading those comments to hear how people have suffered and how valuable our work of creating awareness is. Please find information about specific drugs on the pharma web site www.medicines.org.uk and review the data on the SPC (summary of product characteristics) for full information about some of the possible side effects. Please follow us on Twitter @APRIL_charity
Please scroll down this blog for important information about antidepressants, Dianette, Non psychiatric drugs linked to suicidal behaviour and depression in a recent study by Professor Munir Pirmohamed and others. Until the revised web site is available, it is still possible to research the information about medicines or other data on our web site archived by Wayback Machine - just go to the web site : http://web.archive.org/web/*/www.april.org.uk waybackmachine.org is a great resource and they state for www.april.org.uk it has been
31 August 2016 on BBC TV Victoria Derbyshire programme focus was partly on the #psychiatric adverse reactions to #Lariam #Mefloquine the drug recommended for prevention of #malaria
After hearing the evidence in the programme one may wonder why nothing was done to protect the public and our troops from the long term mental health issues triggered by this drug, there are suicides and homicides linked to the adverse effects too.
The answer is the pharmaceutical company threatened that if any kind of campaigning were to continue in the UK the cost would be too great.
APRIL has a dossier of testaments from the public about the dreadful effects of the drug. It may be of use for 'curing' malaria but as a preventative the harm seems to outweigh the benefit.
Apart from editing and revising the web site, Millie Kieve the founder of APRIL Tweets to doctors and others - Please follow us on Twitter @APRIL_charity This week a good result was when Dr Mark Porter mention Millie Kieve had tweeted to ask why he did not promote patient reporting of ADRs:
After radio 4 programme 'Inside Health' prog last week (2nd & 3rd August), item on statins, when they discussed the conflicting evidence re benefits and harms. I tweeted direct to Dr Mark Porter how important to balance the misinformation and why did he not promote the Yellow Card reporting system for patients as doctors so seldom report ADRS. (more than one tweet of course as words so limited in tweets!) - I believe the incidents of memory loss, depression and muscle weakness caused by statins is under reported!
And Dr Porter quoted my tweet to instigate a discussion on Yellow Card reporting in this week's prog and even mentioned my name!
This is about 15 mins into the programme after the hip treatment discussion.
I hope the MHRA will be pleased but still wonder why they don't do more to publicise the Yellow Card system. This lack of effort to promote the scheme to the public re-enforces the Health Committee Inquiry finding: The MHRA have a conflict of interest in trying to manage safety of medicines while they are supported by and have to promote the pharmaceutical industry.
However, the true risk for all associated serious harms, such as deaths, aggression, akathisia and suicidal thoughts and attempts, remains unknown for children, adolescents and adults, say experts. This is because of the poor design of clinical trials that assess these antidepressants, and the misreporting of findings in published articles.
Selective serotonin reuptake inhibitors antidepressants (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are the most commonly prescribed drugs for depression. A team of researchers from Denmark carried out a systematic review and meta-analysis of 68 clinical study reports of 70 trials with 18,526 patients to examine use of antidepressants and associated serious harms. These included deaths, suicidal thoughts and attempts as well as aggression and akathisia, a form of restlessness that may increase suicide and violence.
They examined double blind placebo controlled trials that contained patient narratives or individual patient listings of associated harms.
Harms associated with antidepressants are often not included in published trial reports, explain the authors. This is why they analysed clinical study reports, prepared by pharmaceutical companies for market authorisation, and summary trial reports, both of which usually include more information. In adults, they found no significant associations between antidepressants and suicide and aggression. However, a novel finding showed there was a doubling of risk for aggression and suicides in children and adolescents.
This study has shown limitations in trials, not only in design, but also in reporting of clinical study reports, which may have lead to "serious under-estimation of the harms," write the authors. They compared the results from the clinical study reports with data from individual patient listings or narratives of adverse effects. This revealed misclassification of deaths and suicidal events in people taking antidepressants.
For example, four deaths were misreported by a pharmaceutical company, in all cases favouring the antidepressant, and more than half of the suicide attempts and suicidal ideation, for example, were coded as "emotional lability" or "worsening of depression." In the Eli Lilly summary trial reports, almost all deaths were noted, but suicidal attempts were missing in 90% of instances, and information on other outcomes was incomplete. These were "even more unreliable than we previously suspected," write the authors.
Clinical study reports for antidepressants duloxetine, fluoxetine, paroxetine, sertraline and venlafaxine were obtained from regulatory agencies in the UK and Europe. Summary trial reports for duloxetine and fluoxetine were taken from the drug company Eli Lilly's website.
However, clinical study reports could not be obtained for all trials and all antidepressants, and individual listings of adverse outcomes for all patients were available for only 32 trials. "The true risk for serious harms is still unknown [because] the low incidence of these rare events, and the poor design and reporting of the trials, makes it difficult to get accurate effect estimates," they explain.
They recommend "minimal use of antidepressants in children, adolescents, and young adults, as the serious harms seem to be greater, and as their effect seems to be below what is clinically relevant," and suggest alternative treatments such as exercise or psychotherapy. They also call for the need to identify "hidden information in clinical study reports to form a more accurate view of the benefits and harms of drugs."
In an accompanying editorial, Joanna Moncrieff from University College London, agrees that "regulators and the public need access to more comprehensive and reliable data", and that clinical study reports "are likely to underestimate the extent of drug related harms." Over half the clinical study reports had no individual patient listings and "this begs the question of how many more adverse events would have been revealed if [these] were available for all trials, and raises concerns why this information is allowed to be withheld." Link to research Link to editorial
Additional information about antidepressant trial data added to this blog February 2017
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. In2012 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.
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.
We recommend considering talking therapy and CBT to 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.
