Primodos EWG Report : Hannah Bardell MP Talks

Will the Primodos victims, and the new science evidence, be at the heart of the Government report ?

On 21 February 2018, Hannah Bardell, SNP MP for Livingston, raised concerns about the Primodos hormone pregnancy test drug, and asked important questions to the Health Secretary.

Primodos EWG Report : Emma Reynolds MP Talks

Will all Primodos victims be listened to ?

On 24 October 2018, Emma Reynolds, Labour MP for Wolverhampton North East, asked Health Secretary to guarantee women who took hormone pregnancy test Primodos will have time to tell their stories to review into claims it caused birth defects and miscarriages.

Families, including one in Reynolds’ constituency, must have confidence in the review. Answers long overdue.

Oral hormone pregnancy tests and the risks of congenital malformations

A systematic review and meta-analysis, October 2018.
Includes Primodos drug victims testimonials.

Overview

  • Sources :
    • read and/or download the full study (free access) Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, First published 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
    • read and/or download the full study (free access) The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, nature, Published 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • Testimonials : read some real stories told by the Primodos victims, see the post comment section.
  • Commenting : scroll down this page until you reach the header “Have your say! Share your views” and the box “Enter your comment here…“.

Abstract

Background
Oral hormone pregnancy tests (HPTs), such as Primodos, containing ethinylestradiol and high doses of norethisterone, were given to over a million women from 1958 to 1978, when Primodos was withdrawn from the market because of concerns about possible teratogenicity. We aimed to study the association between maternal exposure to oral HPTs and congenital malformations.

Methods

I am fully supportive of this article on the effects of hormone pregnancy tests as it stands. I have no substantive criticism of the content or methods.

Dr David Healy, professor of psychiatry, psychopharmacologist, scientist and author.

We have performed a systematic review and meta-analysis of case-control and cohort studies that included data from pregnant women and were exposed to oral HPTs within the estimated first three months of pregnancy, if compared with a relevant control group. We used random-effects meta-analysis and assessed the quality of each study using the Newcastle–Ottawa Scale for non-randomized studies.

Results
We found 16 case control studies and 10 prospective cohort studies, together including 71 330 women, of whom 4209 were exposed to HPTs.

Exposure to oral HPTs was associated with a 40% increased risk of all congenital malformations: pooled odds ratio (OR) = 1.40 (95% CI 1.18 to 1.66; P<0.0001; I2 = 0%).

Exposure to HPTs was associated with an increased risk of

  • congenital heart malformations: pooled OR = 1.89 (95% CI 1.32 to 2.72; P = 0.0006; I2=0%);
  • nervous system malformations OR = 2.98 (95% CI 1.32 to 6.76; P = 0.0109 I2 = 78%);
  • gastrointestinal malformations, OR = 4.50 (95% CI 0.63 to 32.20; P = 0.13; I2 = 54%);
  • musculoskeletal malformations, OR = 2.24 (95% CI 1.23 to 4.08; P= 0.009; I2 = 0%);
  • the VACTERL syndrome (Vertebral defects, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal anomalies, and Limb defects), OR = 7.47 (95% CI 2.92 to 19.07; P < 0.0001; I2 = 0%).

Conclusions
This systematic review and meta-analysis shows that use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.

Reactions

Prof. Henegan’s systematic analyses of epidemiological studies, is a scientific review which members of the Association for children damaged by HPT’s have waited over 45 years for. The findings are incredible and mirror the congenital abnormalities suffered by our members. It is a scandal that this epidemiological study was not commissioned by the Government Health Authorities and we cannot thank Prof. Heneghan and his colleagues enough, for the comprehensive and utterly compelling review.

Marie Lyon,
Assocation for Children Damaged by Hormone Pregnancy Tests, UK

Important Note

Are you a Primodos-victim ?
Send a request to join the group Primodos (The Forgotten Thalidomide) ACDHPT on Facebook.

Médicaments et grossesse : les bons réflexes, rappel ANSM 2018

De manière générale, l’utilisation de médicaments, y compris ceux vendus sans ordonnance, doit être évitée au cours de la grossesse

Points Clés

  • Prévenir son médecin d’un projet de grossesse
  • Pas d’automédication
  • Informer les professionnels de santé de sa grossesse
  • Ne pas arrêter un traitement sans avis médical

En cas d’affection aigue ou chronique le professionnel de santé peut envisager la nécessité d’un traitement médicamenteux chez une femme au cours de sa grossesse.

Si un traitement s’avère nécessaire, il revient au prescripteur d’en évaluer le bénéfice risque pour la patiente et son enfant à naître.

La patiente ne doit en aucun cas prendre un médicament sans avoir préalablement pris conseil auprès d’un professionnel de santé.

La patiente ne doit dans aucun cas arrêter ou modifier un traitement qui lui a été prescrit sans en avoir préalablement parlé avec son médecin, sa sage-femme ou son pharmacien. Cela peut entraîner des risques pour elle et/ou l’enfant à naître.

Dossier Spécial ANSM

MHRA has approved the brand name Xonvea® to be used for marketing Diclectin® in the UK

New NHS drug for “morning sickness”, approved July 2018

Alliance Pharma plc (AIM: APH), the specialty pharmaceutical company, announces that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the UK Marketing Authorisation Application for Diclectin®, a prescription product for the treatment of nausea and vomiting of pregnancy.

Alliance also confirms that the MHRA has approved the brand name Xonvea®, which will be used for marketing Diclectin in the UK. As previously indicated, Alliance anticipates Xonvea’s launch in autumn this year as the only medicine licensed in the UK for the treatment of nausea and vomiting of pregnancy.

Xonvea was in-licensed from Duchesnay Inc. of Canada (“Duchesnay”) for the UK in 2015 and for a further nine European countries in 2016 – Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Republic of Ireland and Switzerland.

Nausea and vomiting of pregnancy is the most common medical condition in pregnancy affecting approximately 690,000 women in the UK each year according to the Office of National Statistics and the Royal College of Obstetricians and Gynaecologists. Research shows that up to 40% of pregnant women report symptoms of nausea and vomiting of pregnancy sufficiently severe to interfere with daily life whilst NHS data shows that at least 33,000 women with the condition are hospitalised each year.

The Group estimates peak sales for Xonvea in the UK of approximately £10m and across the other nine European countries a further £30m approximately at peak sales. The Group will incur both upfront costs ahead of the launches in the UK and EU markets and further incremental costs to support in-market growth in these countries. Alliance expects to generate meaningful sales of Xonvea from H2 2019.

Xonvea is the most studied medicine in pregnancy, with a proven efficacy and safety profile from use in more than 30 million women over more than 30 years. Following marketing authorisation in the UK, Alliance is preparing to file the necessary applications for regulatory approvals in continental Europe.

Related : read What you don’t know about a leading morning-sickness drug, by Anne Kingston Oct 23, 2015 on macleans.

Endometriosis and pregnancy outcome : women with previously excised posterior DIE

Obstetric complications after laparoscopic excision of posterior deep infiltrating endometriosis: a case–control study

2018 Study Abstract

In this issue, Nirgianakis et al. present a retrospective analysis of the complications of pregnancy after laparoscopic excision of deep infiltrating endometriosis (DIE). Most important is that excision of DIE does not affect the increased risk of placenta previa, gestational hypertension, and intrauterine growth retardation (IUGR) associated with endometriosis. In addition, the risk of a vaginal delivery was not increased in the entire group or in the 26 women with a vaginal excision of endometriosis.

Read the full text (free access).
Fertility and Sterility, Volume 110, Issue 3, Pages 406–407, August 2018.

DES Exposure and Endometriosis

Can exposure to insecticide during pregnancy link to autism in children ?

Association of Maternal Insecticide Levels With Autism in Offspring From a National Birth Cohort

New research published in the American Journal of Psychiatry says that exposure to the notorious pesticide dichlorodiphenyltrichloroethane (DDT) during pregnancy could raise the risk of a child developing autism, ScienceAlert reports.

2018 Abstract

Objective
Autism is a complex neurodevelopmental disorder with a largely unknown etiology. To date, few studies have investigated prenatal exposure to toxins and risk of autism by using maternal biomarkers of exposure. Persistent organic pollutants are lipophilic halogenated organic compounds and include the insecticide dichlorodiphenyltrichloroethane (DDT), as well as its metabolite p,p′-dichlorodiphenyl dichloroethylene (p,p′-DDE), and polychlorinated biphenyls (PCBs). The objective of this study was to test whether elevated maternal levels of persistent organic pollutants are associated with autism among offspring.

Method
The investigation was derived from the Finnish Prenatal Study of Autism, a national birth cohort study based on a nested case-control design. Cases of autism among children born between 1987 and 2005 were ascertained by national registry linkages. In cases of childhood autism and matched control subjects (778 matched case-control pairs), maternal serum specimens from early pregnancy were assayed for levels of p,p′-DDE and total levels of PCBs.

Results
The odds of autism among offspring were significantly increased with maternal p,p′-DDE levels that were in the highest 75th percentile, with adjustment for maternal age, parity, and history of psychiatric disorders (odds ratio=1.32, 95% CI=1.02, 1.71). The odds of autism with intellectual disability were increased by greater than twofold with maternal p,p′-DDE levels above this threshold (odds ratio=2.21, 95% CI=1.32, 3.69). There was no association between total levels of maternal PCBs and autism.

Conclusions
These findings provide the first biomarker-based evidence that maternal exposure to insecticides is associated with autism among offspring. Although further research is necessary to replicate this finding, this study has implications for the prevention of autism and may provide a better understanding of its pathogenesis.

Primodos Hormone Pregnancy Test Testimonials, 2018

Hormone Pregnancy Test Drug Given to 1.5M Linked to Birth Defects

Three mums speak out as they believe it is the primodos drug that left their children with devastating health issues.

The women who were given a hormone pregnancy test have shared emotional stories of the terrible health problems their children are forced to live with.

Reference.

Le lien entre la prise de distilbène de la (grand-)mère et la stérilité de la descendance

Toute une histoire, vidéo publiée le 5 octobre 2015

Le distilbene est un “modèle” des perturbateurs endocriniens.

Le Distilbène DES, en savoir plus

Une fille Distilbène sans enfants témoigne

Extrait d’un journal de bord d’une femme numérique, juin 2017

“Il faut de tout pour faire un monde”,
… et …
“à toute chose malheur est bon”.

dit on… voici un témoignage, d’une fille distilbène, qui sort de l’ordinaire…

Le Distilbène DES, en savoir plus