Enligt panelen har prevalensen av fosterskador från SSRI undanhållits allmänheten
Kvinnor blir inte informerade om de potentiella riskerna, t.o.m. ljugna i ansiktet om att SSRI inte medför några risker för fostret.
En del skador som tas upp är abort, autism, FAS, hjärtfel.
Det centrala temat i panelen är att det saknas informerat medgivande och forskningen är snedvriden till läkemedelsbolagens fördel.
Utöver det tar de upp att SSRI inte har en påvisad effekt på depression, så att du utsätter fostret för fara utan att det är till gagn mot depressionen.
The NICE review data suggest that selective serotonin reuptake inhibitors do not have a clinically meaningful advantage over placebo, which is consistent with other recent meta-analyses. In addition, methodological artefacts may account for the small effect seen. Evidence that antidepressants are more effective in more severe conditions is not strong, and data on long term outcome of depression and suicide do not provide convincing evidence of benefit. In children, the balance of benefits to risks is now recognised as unfavourable. We suggest this may also be the case for adults, given the continuing uncertainty about the possible risk of increased suicidality as well as other known adverse effects.
https://pmc.ncbi.nlm.nih.gov/articles/PMC558707/
Detta är oroande med tanke på det kraftigt ökande bruket av SSRI världen över, men i synnerhet här i norden. Kvinnor här i Norden tar ca 2/3 av alla antidepressiva som skrivs ut.
https://nhwstat.org/health/pharmaceutical-products/prevalence/antidepressants-prevalence
Informeras kvinnor ordentlig här i Sverige? Erkänner man att dessa skador existerar, eller försöker man lägga locket på här med?
Paxil var en antidepressiv som orsakade en skandal över fosterskador.
GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.
https://pmc.ncbi.nlm.nih.gov/articles/PMC558707/
Two studies have found an association between first trimester paroxetine use and congenital malformations, notably cardiac malformations. The first study, completed in 2005, showed “a trend towards a 1.5-fold increased risk for cardiovascular malformations for paroxetine compared to other antidepressants. This study also showed a statistically significant increased overall risk of major congenital malformations (inclusive of the cardiovascular defects) in infants exposed to paroxetine compared to other antidepressants.”1
In the second study, an analysis of data from the Swedish Medical Birth Register revealed an association between use of paroxetine and cardiovascular congenital defects, most notably ventricular and atrial septal defects.2 On the basis of these two studies and at the FDA's request, GlaxoSmithKline downgraded their rating of paroxetine safety in pregnancy to category D.3
https://www.aafp.org/pubs/afp/issues/2012/0415/p747.html
Är vi mitt i en sådan skandal just nu?
Artikel om panelen
FDA panel weighs risks, benefits of antidepressants during pregnancy
https://www.healio.com/news/womens-health-ob-gyn/20250721/fda-panel-weighs-risks-benefits-of-antidepressants-during-pregnancy
Panellisterna:
Kvinnor blir inte informerade om de potentiella riskerna, t.o.m. ljugna i ansiktet om att SSRI inte medför några risker för fostret.
En del skador som tas upp är abort, autism, FAS, hjärtfel.
Det centrala temat i panelen är att det saknas informerat medgivande och forskningen är snedvriden till läkemedelsbolagens fördel.
Utöver det tar de upp att SSRI inte har en påvisad effekt på depression, så att du utsätter fostret för fara utan att det är till gagn mot depressionen.
The NICE review data suggest that selective serotonin reuptake inhibitors do not have a clinically meaningful advantage over placebo, which is consistent with other recent meta-analyses. In addition, methodological artefacts may account for the small effect seen. Evidence that antidepressants are more effective in more severe conditions is not strong, and data on long term outcome of depression and suicide do not provide convincing evidence of benefit. In children, the balance of benefits to risks is now recognised as unfavourable. We suggest this may also be the case for adults, given the continuing uncertainty about the possible risk of increased suicidality as well as other known adverse effects.
https://pmc.ncbi.nlm.nih.gov/articles/PMC558707/
Detta är oroande med tanke på det kraftigt ökande bruket av SSRI världen över, men i synnerhet här i norden. Kvinnor här i Norden tar ca 2/3 av alla antidepressiva som skrivs ut.
https://nhwstat.org/health/pharmaceutical-products/prevalence/antidepressants-prevalence
Informeras kvinnor ordentlig här i Sverige? Erkänner man att dessa skador existerar, eller försöker man lägga locket på här med?
Paxil var en antidepressiv som orsakade en skandal över fosterskador.
GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.
https://pmc.ncbi.nlm.nih.gov/articles/PMC558707/
Two studies have found an association between first trimester paroxetine use and congenital malformations, notably cardiac malformations. The first study, completed in 2005, showed “a trend towards a 1.5-fold increased risk for cardiovascular malformations for paroxetine compared to other antidepressants. This study also showed a statistically significant increased overall risk of major congenital malformations (inclusive of the cardiovascular defects) in infants exposed to paroxetine compared to other antidepressants.”1
In the second study, an analysis of data from the Swedish Medical Birth Register revealed an association between use of paroxetine and cardiovascular congenital defects, most notably ventricular and atrial septal defects.2 On the basis of these two studies and at the FDA's request, GlaxoSmithKline downgraded their rating of paroxetine safety in pregnancy to category D.3
https://www.aafp.org/pubs/afp/issues/2012/0415/p747.html
Är vi mitt i en sådan skandal just nu?
Artikel om panelen
FDA panel weighs risks, benefits of antidepressants during pregnancy
https://www.healio.com/news/womens-health-ob-gyn/20250721/fda-panel-weighs-risks-benefits-of-antidepressants-during-pregnancy
Panellisterna:
Anick Bérard, Ph.D.
Professor of Perinatal Epidemiology, University of Montreal, Faculty of Pharmacy, and CHU Ste-Justine in Montreal; and Adjunct Professor at the Faculty of Medicine, Université Claude Bernard
Jay Gingrich, M.D., Ph.D.
Director, Institute for Developmental Sciences, Professor of Developmental Psychology (in Psychiatry), Columbia University Irving Medical Center
David Healy, M.D., Fellow of the Royal College of Psychiatrists
Founder and CEO of Data Based Medicine, North Wales, UK (formerly Professor of Psychiatry at McMaster University in Canada, and Bangor and Cardiff Universities in the UK)
Jeffrey Lacasse, Ph.D., M.S.W.
Associate Professor, College of Social Work, Florida State University
Michael Levin, Ph.D. (virtual)
Distinguished Professor, Department of Biology and Director of the Allen Discovery Center at Tufts University
Roger McFillin, Psy.D.,
American Board of Professional Psychology
Clinical Psychologist, Executive Director of the Center for Integrated Behavioral Health
Joanna Moncrieff, M.D. (virtual)
Professor of Critical and Social Psychiatry at University College London and practising psychiatrist
Kay Roussos-Ross, M.D.
Professor and Chief, Division Academic Specialists in General Obstetrics and Gynecology, Director of Perinatal Mood Disorders Program, Department of Obstetrics and Gynecology and Psychiatry, University of Florida College of Medicine
Adam Urato, M.D.
Chief, Maternal-Fetal Medicine, MetroWest Medical Center
Josef Witt-Doerring, M.D.
Psychiatrist, Taperclinic (Former FDA Medical Officer)
Professor of Perinatal Epidemiology, University of Montreal, Faculty of Pharmacy, and CHU Ste-Justine in Montreal; and Adjunct Professor at the Faculty of Medicine, Université Claude Bernard
Jay Gingrich, M.D., Ph.D.
Director, Institute for Developmental Sciences, Professor of Developmental Psychology (in Psychiatry), Columbia University Irving Medical Center
David Healy, M.D., Fellow of the Royal College of Psychiatrists
Founder and CEO of Data Based Medicine, North Wales, UK (formerly Professor of Psychiatry at McMaster University in Canada, and Bangor and Cardiff Universities in the UK)
Jeffrey Lacasse, Ph.D., M.S.W.
Associate Professor, College of Social Work, Florida State University
Michael Levin, Ph.D. (virtual)
Distinguished Professor, Department of Biology and Director of the Allen Discovery Center at Tufts University
Roger McFillin, Psy.D.,
American Board of Professional Psychology
Clinical Psychologist, Executive Director of the Center for Integrated Behavioral Health
Joanna Moncrieff, M.D. (virtual)
Professor of Critical and Social Psychiatry at University College London and practising psychiatrist
Kay Roussos-Ross, M.D.
Professor and Chief, Division Academic Specialists in General Obstetrics and Gynecology, Director of Perinatal Mood Disorders Program, Department of Obstetrics and Gynecology and Psychiatry, University of Florida College of Medicine
Adam Urato, M.D.
Chief, Maternal-Fetal Medicine, MetroWest Medical Center
Josef Witt-Doerring, M.D.
Psychiatrist, Taperclinic (Former FDA Medical Officer)