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Rapid Responses: Rapid Responses published:
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Paxil(Paroxetine) is useful in children
- Keith L Meloff MD,FRCPC (15 June 2003)
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Smile if you've been depressed.......
- Declan P Fox (15 June 2003)
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Re: Paxil(Paroxetine) is useful in children
- Dr. Tim J Williams, Cherie Benns. Clinical Psychology Intern (16 June 2003)
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"Off-Label" use of drugs in Children
- Deborah j Wood (20 June 2003)
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A setback in the treatment of youthful MDD?
- Mauri J Marttunen (25 June 2003)
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PANORAMA AND ADDED DRAMA
- Rita Pal (2 July 2003)
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Threat of suicide leads to ban of major antidepressants for children
- Macey L Murray, Corinne S de Vries and Ian CK Wong (16 December 2003)
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Keith L Meloff MD,FRCPC, Adjunct Professor of Pediatrics(Neurology) University of Western Ontario,London Ontario
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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 |
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Declan P Fox, Peripatetic primary care physician O'Leary, Prince Edward Island, C0B1V0, Canada
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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 |
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Dr. Tim J Williams, Senior Clinical Psychologist Christchurch College of Education, Christchurch 8006, New Zealand, Cherie Benns. Clinical Psychology Intern
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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 |
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Deborah j Wood, Home care RN Home care RN
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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 |
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Mauri J Marttunen, Head of department of Adolescent Psychiatry, peijas Hospital, Helsinki University Hospital Peijas Hospital, Metsolantie 4, FIN-01450, Vantaa, Finland
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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 |
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Rita Pal, Editor NHS Exposed www.nhs-exposed.com XXXXXXXXXXXXXXXXXX
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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. |
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Macey L Murray, Research fellow Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London, WC1N 1AX, Corinne S de Vries and Ian CK Wong
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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/ssrioverview_101203.htm (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. |
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