Paroxetine must not be given to patients under 18
BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7402.1282-b (Published 12 June 2003) Cite this as: BMJ 2003;326:1282
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Last year, I worked in the north. Panorama had just shown their
supposedly well researched material on Paroxetine. Firstly, I think there
seems to be an absence of clinical opinions on Paroxetine. I am therefore
going to take this opportunity to present my opinion because I feel that
clinical opinions from the person dealing with the side effects of the
potent drug known as Panorama should be examined.
Many of my colleagues agree that Paroxetine has helped many people.
Indeed, having treated many people with the drug, there has been a
significant improvement in their quality of life. Firstly, it should be
borne in mind that Paroxetine is used to treat depressed people. This
means the probability of suicidal ideation is much higher in this group of
patients by the nature of their illness. Suicidal ideation is dependant on
multiple factors eg environment, life events, mental state etc. No drug is
perfect but this means a number of studies need to be done before the DOH
issues guidelines based on a knee jerk reaction governed by Panorama.
After watching Panorama, a large amount of patients deteriorated as
they simply "stopped their tablets" because of Panorama. This is an
example where the media plays doctor. It is a known fact that abruptly
stopping Paroxetine will give a number of withdrawal symptoms. Over that
period of two weeks, we must have had about 40 patients suffering from
relapses. These are people who had been well for a number of years on this
drug.
Personally, having had the unfortunate experience of being in
personal contact with Panorama in the past; I found them to be
unscientific, jumping on whatever bandwagon they wish, featuring
interviews from patients whose histories were not examined ie whether they
were non compliant with medication or whether their suicide risk prior
and after treatment had been examined. Fear instilled in vulnerable
patients by a powerful medium like Panoram who have limited initial
information on Paroxetine is dangerous.
The scientific data measuring the number of relapses following the
Panorama programme is not publicised. Panorama should also take the
responsibility of leaving doctors to pick up the pieces that they have
created. They should also realise that they are playing with peoples'
lives - which is not worth the terror journalism that was featured.
Currently we see a knee jerk reaction to a media frenzy.People who
have recovered stop their medication and relapse badly. If Panorama want
to pay for the extra admissions that they have directly caused, then they
should provide me with their number. Indeed, perhaps they should sit up at
3am in the morning and take a look at what they have caused.
Journalists are not doctors. Indeed, some journalists feel they can
play God with peoples' lives simply for a media frenzy. I say this from
personal experience of many journalists including being questioned by
Panorama at one point. A certain researcher once asked me to take a camera
and film patients breaching their confidentiality. I refused. These people
are not concerned with the welfare of patients but simply " a story". They
also fail to be accountable for the vast range of problems they cause.
Kind Regards
Dr Rita Pal
www.nhs-exposed.com
PS I would be interested to know whether Panorama would fund the beds
we require for each relapsing patient with the first presenting line "
Doctor, I stopped Paroxetine because Panorama featured all the bad points
about it".
Competing interests:
Interviewed by researcher from Panorama on a different subject.
Competing interests: No competing interests
This news that the MHRA advises not to give paroxetine to patients
aged under 18 years due to increased risk for suicidal ideation or
behaviour is important from the viewpoint of clinical practice. According
to the news, the MHRAs advise is based on nine studies where 3.4 % of
subjects on paroxetine had suicidal ideation or behaviour compared with
1.2 % of those on placebo. Interestingly, the results of only one of the
studies was "in the public domain". This fact might reflect publication
bias in research.
Although suicide is a common consecuence of depression in adolescence
(Marttunen et al, 1991) surprisingly few published studies on the efficacy
of psychosocial or psychopharmacological treatment of youthful MDD report
changes in the subjects´ suicidality. To obtain more data on the issue
measures of suicidality should perhaps be included as secondary outcome
measures in future efficacy studies.
Due to lack of evidence of the efficacy of tricyclic antidepressants
in youth major depression (MDD)(Hazell et al, 1995), there are not too
many options in the psychoparmacological treatment of adolescent MDD.
Based on the increasing research evidence on the efficacy (e.g. Emslie et
al, 1997, 2002; Keller et al, 2001) of the selective serotonine reuptarke
inhibitors (SSRI) in youthful MDD many clinicians around the world
prescribe these agents to treat adolescent MDD.
Researchers and clinicians should have access to the data MHRAs
advise is based on. Therefore, as soon as possible, the data should be
published in a scientific journal using peer review.
I am a researcher and a clinician currently preparing a review on
antidepressants in the treatment of adolescent MDD and I would like to
refer to the MHRAs findings.
I was wondering whom I could contact to obtain more data on the relevant
studies the MHRAs advise is based on. Can you help me?
Mauri Marttunen, MD
References:
Emslie G, Rush AJ, Weinberg AW, Kowatch RA, Hughes CW, Carmody T,
Rintelmann J. A double-blind, randomized placebo-controlled trial of
fluoxetine in children and adolescents with depression. Arch Gen
Psychiatry 1997;54:1031-1037.
Emslie GJ, Heiligenstein JH, Wagner KD, Hoog SL, Ernest DE, Brown E,
Nilsson M, Jacobson JG. Fluoxetine for acute treatment of depression in
children and adolescents: a placebo-controlled, randomized clinical trial.
J Am Acad Child Adolesc Psychiatry 2002;41:1205-1215.
Hazell P, O´Connell D, Heathcote D, Robertson J, Henry D. Efficacy of
tricyclic drugs in treating child and adolescent depression: a meta-
analysis. BMJ 1995;310:897-901.
Keller MB, Ryan ND, Strober M, et al. Efficacy of paroxetine in the
treatment of adolescent major depression: a randomized, controlled trial.
J Am Acad Child Adolesc Psychiatry 2001;40:762-72.
Marttunen M, Aro H, Henriksson M, Lönnqvist J. Mental disorders in
adolescent suicide. DSM-III-R axes I and II in suicides among 13 to 19
year olds in Finland. Arch Gen Psychiatry 1991;48:834-839.
Competing interests:
None declared
Competing interests: No competing interests
No drugs should be allowed to be given to any child without clinical
testing and approval by the licensing government agency. Children deserve
to have all drugs tested for safety and effacacy to meet their special
requirements. The loss of one child because the drug was used "off-label"
is arrogantly offensive negligence because some physician deemed it
appropriate.
My son has been left with severe anoxic encephalopathy after being
given a drug "off-label" in ICU for sedation. He was also given 42 mg of
Ativan "off-label" in a 16 hour period for agitation, 26 of those 42 mg in
the 5 hour period preceding a bolus dose of Diprivan. No one considered
his mental illness and known paradoxical side effects of the Ativan. The
nurse just kept giving him more and more. The Diprivan order was given
telephonically by the on-call resident and the nurse gave the Diprivan.
His vital signs took an immediate turn to the worse, drop in blood
pressure, pulse, O2 sat's. The resident did not recognize the EKG reading
as "Sinus arrest- Idioventricular rhythm" and call the attending. My child
was coded for severe bradycardia and the Diprivan was put on "Hold" by the
arriving attending two hours later. The day shift nurse came on duty and
restarted the Diprivan 2 hours later without a restart order. He suffered
a catastrophic code, PEA, that has left him as he is now. The FDA
mandated a "Dear Doc" warning letter to all healthcare providers in 2001.
In spite of that and in spite of the hue and cry about malpractice rates,
doctors continue to defiantly defend and use Diprivan for pediatric ICU
sedation.
Now we will see the same defence of Paxil. No child, no family
should ever suffer as we have because a physican decided he/she knows
better than the governing entity that oversee's and trys to be unbiased in
its recommendations regarding the use of medications.
I commend the UK and the BMJ for what I know is the fairest reporting
of issues in regards to our children. I have gone to many hundreds of
sites and have read even more articles in regards to this issue. My
salvation is to try and impart caution in those who prescribe medications
to our vulnerable, trusting children.
He had also been given Paxil as part of his treatment at one time and
that seemed to exacerbate his depression. He was diagnosed as bipolar 2
rapid cycling, schizoaffective disorder probable early onset schizophrenia
at age 14. His illness surfaced at age 12. We had been warned we must
avoid psychotic breaks at all costs. He was never without the care of a
psychiatrist and therapist. Unfortunately here in Texas we have this
ludacrous law that states that a 16 year old child is in charge of their
therapy, whether to continue therapy and life saving antipsychotics. My
child, wanting to be "normal" and with the blessing of his psychiatrist
and the state of Texas, decided to stop the antipsychotics and try
Lithium. He ended up on Verapamil and Elavil several months later and
after seven weeks of that combination, he overdosed in a severe agitated
psychotic state.
We went through years of trial and error with psychiatrists,
therapists and medications. Mental illness is a lonely, socially
stigmatized nightmare. Use other medications that have been used safely
without causing more harm to the child.
Competing interests:
None declared
Competing interests: No competing interests
In response to Dr. Meloff's statement that there is a lack of
effective therapy for common child and adolescent disorders such as
conduct problems and anxiety disorders, we would encourage the doctor to
consult a wider range of published literature in this area. A search of
PsycINFO or Medline will guide the reader to a vast body of evidence-based
research on effective treatments for childhood and adolescent disorders.
As these approaches are primarily psychological in nature they have no
potentially lethal side effects and are safe for even the youngest
children. Furthermore, readers will note that this body of literature is
supported by robust research findings and that, unlike much of the
research in pharmacological treatments, it is designed for, and tested on,
the target population.
Competing interests:
None declared
Competing interests: No competing interests
When you have been depressed for a long time you sometimes reach some
kind of equilibrium with your condition, a bit like patients with chronic
pain where the manifestations differ from acute pain. Perhaps the
depression does not seem so bad if it is there all the time and you lack
the emotional energy to respond to it.
But when things start improving, the bad days seem a whole lot worse by
comparison with the good. A possible explanation for suicides on
treatment???
Yours
Declan Fox
Competing interests:
None declared
Competing interests: No competing interests
Your editorial advising against the use of Paroxetine in children
will create havoc in the care of children and adolescents with significant
neuropsychiatric problems such as obsessive-compulsive disorder, Tourette
syndrome, oppositional-defiant disorder, panic/phobia, etc.
Paroxetine is widely used in Canada for these problems, often with
considerable success. Your advice would be more acceptable if your experts
offered reasonable alternatives- a regrettable omission.
In fact, none of the alternatives for treating the above disorders has
been approved in children- and this is a global problem in drug
development, namely the lack of suitably controlled studies of
psychotropic medicines in the 6-18 age group. The BMJ owes it to its
readers to offer evidence-based recommendations for the treatment of
childhood mental health problems especially when issuing dire warnings.
Those of us engaged in the care of these children anxiously await your
response.
Respectfully submitted-Keith Meloff, MD, FRCPC
Competing interests:
None declared
Competing interests: No competing interests
Threat of suicide leads to ban of major antidepressants for children
Editor-The recommended withdrawal of the use of selective serotonin
reuptake inhibitors (SSRIs) in children, announced by the Medicines and
Healthcare products Regulatory Agency (MHRA)(1,2), has prompted us to
report our preliminary findings on the prescribing trends of
antidepressants (ATDs) in children and adolescents in general practice.
We are involved in a project called CHAPTER (Child and Adolescence
Psychotropic medication Therapy Evaluation Research), which evaluates the
safety and use of psychotropic medications in children and adolescents. We
are particularly interested in patterns of tricyclic antidepressants
(TCAs) and SSRI use, as their efficacy in paediatric depressive disorders
has been questioned. Our data come from the General Practice Research
Database(3), which covers approximately 5% of the UK population. We
carried out a study of ATDs utilisation between 1 January 1992 and 31
December 2001.
We found 23,999 children and adolescents were prescribed at least one
ATD, and the total number of ATD prescriptions issued was 88,522. Fifty-
nine percent of prescriptions were for TCAs, 40% were for SSRIs. The most
commonly prescribed ATDs were imipramine (25% of prescriptions),
fluoxetine (19%), and amitriptyline (18%). Paroxetine, sertraline,
citalopram, venlafaxine, and fluvoxamine made up 21% of all ATD
prescriptions issued. Sixty-three, 35 and 2 percent of patients were given
TCAs, SSRIs, and other ATDs respectively as the first ATD prescribed. Less
than 0.1% of patients received an MAOI.
In patients aged 10 years and less, the most commonly recorded
indication for TCAs use was enuresis (78%), whereas in those aged 15+
years it was depression (53%). In this older age group, ATDs use was three
times more common in girls than boys. Drug choice favoured TCAs in 1992
when they were prescribed to nine times more patients than SSRIs, whereas
by 2001, twice as many patients were prescribed SSRIs than TCAs.
Our findings show that SSRIs had gained popularity for the treatment
of depression compared with TCAs, but TCAs were still being used commonly
in the treatment of nocturnal enuresis. These trends may change following
the MHRA recommendation. However, TCAs are not useful in treating
depression in pre-pubertal children, and there is only marginal evidence
to support the use of TCAs in adolescents(4). This may leave us in a
situation where few effective pharmacological treatments are available, so
there is an urgent need to research more effective and safer medicines for
children and adolescents with depression. Children deserve equal rights
with adults in receiving evidence-based treatment(5).
Macey L Murray
Corinne S de Vries,
Senior lecturer,
Department of Pharmacoepidemiology, Postgraduate Medical School,
University of Surrey, Guildford GU2 7DJ
Ian C K Wong,
Director and reader,
Centre for Paediatric Pharmacy Research, School of Pharmacy, University of
London and Institute of Child Health, University College London
Acknowledgments:
IW's post is funded by Department of Health Public Health Career Scientist
Award
1. http://bmj.bmjjournals.com/uknews/news20031210.shtml (accessed
10/12/2003)
2.
http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/s...
(accessed 12/12/2003)
3. Walley T, Mangani A. The UK General Practice Research Database.
BMJ 1997;350:1097-9.
4. Hazell P, O'Connell D, Heathcote D, Henry D. Tricyclic drugs for
depression in children and adolescents. Cochrane Database Syst Rev.
2002;(2):CD002317
5. Wong ICK, Camilleri-Novak D, Stephens P. Rise in psychotropic drug
prescribing in children in the UK - An urgent public health issue. Drug
Safety 2003;26(15):1117-8.
Competing interests:
IW has received funding from various pharmaceutical companies including companies that produce SSRIs but none were related to this study. MM and CdV have no competing interests to declare.
Competing interests: No competing interests