• 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.

     Information about:   APRIL's Conferences   Report your experience:

    text

  • APRIL's Blog

    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

    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

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    1.                         Gareth Iacobucci

    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 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.ukwww.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

     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


    British Medical Journal Analysis of Study 329


    David Healy’s website on the controversy of Study 329


    Restored Study 329



    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 

    Our submission to the Government Suicide Prevention Inquiry can be viewed on the Parliamentary web site: 
    http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/health-committee/suicide-prevention/written/37700.pdf

     We take the opportunity to request if you may please consider a contribution to help us continue in our work.

    Donations towards the upgrade of the web site will be appreciated - please read our Fundraising Appeal here:

    Link to Charity Choice Fundraising site, click on 'Our Appeals : https://www.charitychoice.co.uk/april

    Direct link to the Appeal:
    https://www.charitychoice.co.uk/april/appeals/psychiatric-side-effects-major-resource-upgrade-of-web-site/626

    Latest news on activities of APRIL


    Please share the link for this remarkable new video documentary by Katinka Newman but can only be viewed on a computer - not on mobile devices unfortunately!
    https://www.youtube.com/watch?v=eEeJtRB5hqg


    Oxford University Press International Journal of Neuropsychopharmacology

    A newly published paper = October 2016  referring to rigged clinical trials covering up suicides and other ADRs caused by antidepressants is also worth reviewing:

    http://ijnp.oxfordjournals.org/content/early/2016/10/25/ijnp.pyw092


    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
    Saved 158 times between August 24, 2000 and April 26, 2016.

    Antimalarial drug
    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


    Follow her on twitter too: @VictoriaLive 

    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.

    details are here:

    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:
    http://www.bbc.co.uk/programmes/b07mxk4g  BBC broadcast 9th & 10th August 2016

    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. 

    Antidepressants double risk of aggression & suicide for young, according to meta analysis of data
    Children and adolescents have a doubled risk of aggression and suicide when taking one of the five most commonly prescribed antidepressants, according to findings of a study published in The BMJ today. (The following is taken from the email sent to APRIL by the BMJ.)

    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. 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.

     

    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.

     

    ©JBforAPRIL

     

    Further Reading

     

    Article on Study 329


    British Medical Journal Analysis of Study 329


    David Healy’s website on the controversy of Study 329


    Restored Study 329



     

    Acne drug Dianette (Diane-35) obtains new depression and suicide risk warning


    Foreword to readers:

    Thanks to women who contacted APRIL and those who have heeded our request to report side-effects for Dianette (Diane-35).

    It is due to the efforts of APRIL for many years requesting the Medicines & Healthcare Products Regulatory Agency to review the emails we received from women, with detailed explanations of the way Dianette affected them, that eventually the MHRA reviewed the drug for safety issues. This review, started in 2006, led to the manufacturers adding an additional warning about depression which previously had been listed under MILD side effects.

    The MHRA requested APRIL to urge these women to report using the Yellow Card system. Compliance with this request has led to reports of psychiatric adverse drug reactions (ADRs) soaring in a few years from 3% of all reports to 33% of all reports by 2011. Due to the increased number of reports recorded on Drug Analysis Prints by the MHRA the manufacturer has added the warning as mentioned below in this post.



    Dianette, the hormonal acne treatment manufactured by the German pharmaceutical company Bayer, has had a label change in the UK, following a number of reports of depression and suicidal thoughts.

    Patient Information Leaflets should now include this warning in each box of Dianette:

    “Post-marketing reports of severe depression (including very rare reports of suicidal ideation or behaviour) in patients using Dianette have been received.  However, a causal relationship between clinical depression and Dianette has not been established.”

    The drug is prescribed to 62,000 British women and millions of women worldwide each year for acne and excessive body hair (hirsutism). Hundreds of adverse drug reactions and some fatalities have been reporting for people taking Dianette, also known as Diane-35 and other generic names.

    In the USAthe medication has not been approvedby the Food and Drug Administration (FDA), and France banned the drug altogether in 2013** after its links to at least four French deaths from blood clots and 125 patients suffering serious side effects. The European medicines agency released a statement reported on BBC News(27 February 2013)about the decision of the French medicines agency ANSM to stop distribution:

    “ANSM considered that Diane-35 and its generics carry a risk of thromboembolism which has been well known for many years, while their effectiveness in treating acne was only moderate and alternative treatments for acne are available.”

    Dianette can be taken off-label as a contraceptive pill, but is unlicensed for this purpose due to its significantly higher risk of blood clots compared to other pills. Professor Dominique Maraninchi, director-general of the ANSM, believes doctors are giving women the drug as a contraceptive off-label too often, saying:

    "Diane-35 is an acne treatment that also blocks ovulation. We have several inquiries going on that show that this non-authorised use is significant."

    Between 2010 and 2013, the MHRA revealed that seven women in the United Kingdom have died whilst taking the drug, with 83 reports of side effects such as thrombosis and depression.

    Last year, a Dutch report revealed up to 27 women, most of whom under 30, died from blood clots believed to be caused by Dianette.

    Despite being listed as a Black Triangle Drug under further review by the medicine’s regulator, Dianette and its generic counterparts remain on license in the UK.

    Earlier this year Jessica Eales, a young sailing champion, took her life after her 17th birthday, following 4 months of using Dianette as an acne treatment. The coroner Graham Short could not conclude any links between her suicide and the drugas she had not presented any noticeable signs of depression before this. The coroner quoted the European Medicines Agency review of Dianette in his report, which had concluded the benefits of the drug outweigh its risks. However, the EU report only took into account the risks in respect of thrombosis; the risk of depression and suicidal thoughts and actions was not considered in this review.

    Following the death of Charlotte Porter, who died of a blood clot in 2010 whilst on Dianette, an MHRA spokesman announced: ‘Dianette is an effective medicine for treating the distressing conditions of severe acne and excessive hair […] Despite recent developments in France, we have no new concerns.’ German manufacturer Bayer said: ‘Bayer believes that Dianette has a favourable benefit-risk profile when used in accordance with the label.’

    Prior to the publicity instigated by APRIL, we were told of many instances where antidepressants were prescribed to women who complained of depression, and left uninformed of the link or told to stop taking Dianette. APRIL’s research on patient safety collated 102 adverse drug reaction reports sent in by 2011 by women on their use of Dianette. Several personal accounts document that once removing themselves from the drug, their mood clears, following severe depression in some instances.  One patient described how “The cloud lifted when I stopped taking Dianette”. Woman’s hour described similar stories in their programme about contraceptive pills and mood.

    This change in patient information is one step forward to informing the patient of the risks to their mental health when taking Dianette. Once a change in a patient leaflet is made, however, the GP may not be aware of the new information. However, we are hopeful that following this change in labelling, there may be further consideration of Dianette’s psychiatric side effects taken by prescribers as well as by coroners.

    Crucially we urge those affected to report adverse side-effects using the Yellow Card reporting system in the UK. From this, we can build a stronger and more accurate profile of this drug for both prescribers and the prescribed to be aware of its risks.


    Jacqueline Bond 

    ** Edit: The ANSM's decision to suspend Dianette was overruled as the European Commission's decision to maintain marketing authorisation was implemented in all EU Member states.

    Non-psychiatric drugs linked to suicidal behaviour and depression in new study

    Adverse side effects of medicines can be underestimated and often not recognised as such. 110 drugs prescribed on the NHS have been linked to depression, self-harm and suicidal behaviour in a scientific study of patient Yellow Cards drug reaction reports sent to the Medicine’s Regulatory agency, the MHRA.

    The paper published this September 2014 in the journal BMC Pharmacology & Toxicology is believed to be the first UK systematic review of psychiatric side-effects. Researchers found reports of 11,000 cases of depression, self injurious and suicidal behaviour following prescribed drug use between 1964 and 2011. This number covered 1.65% of all reports received in this time period.

    Anti-depressants, acne, smoking cessation and weight-loss drugs were most frequently linked with serious psychiatric adverse drug reactions (ADRs). Clozapine, the anti-psychotic drug, had the highest reporting rate of suicide, with 78 reports between 1998 and 2011 linking the fatality to the drug.

    Both nervous system and non-nervous system drugs met the study’s thresholds of at least 20 reports for depression, 10 for non-fatal suicide and 5 for fatal suicide between 1998 and 2011. Topping the charts with most frequent reports of depression were smoking cessation medicine, varenicline (Champix / Chantix) and bupriopion (Wellbutrin / Zyban), followed by paroxetine (Seroxat or Paxil), the SSRI antidepressant. Also high on the list of drugs linked to depression were the acne treatment, isotretinoin (Roaccutane / Accutane), and rimonabant (Acomplia), a drug for weight loss. For suicidal and self injurious behaviour, SSRIs, varenicline and clozapine occurred most often.

    Figures found in the study are likely to underrepresent the true count of iatrogenic effects (drug-induced side effects) as the Yellow Card reporting system remains relatively underused by both patients and healthcare professionals.

    The paper recommends the drugs most commonly arising in patient reports for grave psychiatric conditions need further analysis to understand the reasons why these drugs might be causing undue harm.

    When a drug is licensed for prescription, pre-market trials do not undergo full powered studies into adverse drug reactions (ADRs) as this would require larger numbers of participants. Post-marketing pharmacovigilance using the Yellow Card reporting system and its careful analysis is therefore one of the main ways we can achieve a fuller picture into the neglected area of patient experience with medication.
    Due to poor publicity and the underpowered studies of iatrogenic effects, psychiatric drug reactions and withdrawal effects are neither sufficiently well recognised nor analysed in the medical community. A study published in 2004 found that fewer than half of pharmacy programmes and medical schools provided students with a guide to reporting ADRs. Yet NHS Education for Scotland (NES), in a press release published in June 2014, stated that 7% of acute hospital admissions were due to ADRs. The NES have thus launched six new e-learning modules to support healthcare professionals identifying and reporting iatrogenic symptoms. Clinical pharmacologist Dr Simon Maxwell published an article reporting that undergraduate study is in urgent need of review to improve the safe and effective use of drugs in patients. 74% of medical students felt the amount of teaching in this area of safe prescribing  was ‘too little’ or ‘far too little’, and most disagreed that their assessment ‘thoroughly tested knowledge and skills’.

    If we are to reduce the effect of ADRs on the population, and their economic impact that costs the NHS an estimated £2 billion each year, healthcare professionals and pharmaceutical companies need to make best use of new information made available by patient reporting.

    Jacqueline Bond blogging for APRIL

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