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and high doses of norethisterone, were given to over a million women from 1958 to 1978, when Primodos was withdrawn from the market because of concerns about possible teratogenicity.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.

MPs Call for Public Inquiry into Hormone Pregnancy Tests

Judge-led inquiry into pregnancy drug Primodos not “off the table”, the Government confirmed

There have been growing calls for a public inquiry into the “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests” scandal, after MPs debated the Primodos drug’s legacy.

Severals MPs have joined the Primodos campaigners to say that the Expert Working Group review was a complete whitewash.

House of Commons and House of Lords Debates

  • House of Commons’ talks ref “Hormone pregnancy tests“, 14 December 2017 – 15:20:54 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 10:40:26 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 17:53:45 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 13 October 2016 – 15:05:52 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 21 January 2016 – 11:06:20 parliamentlive.tv.

More About Primodos

Lower-Dose Primodos-like Contraceptives are Still being used Today : is it Safe ?

Primodos EWG Report : Marie Lyon Comments

Marie Lyon, Chair of the Association for Children Damaged by Hormone Pregnancy Tests, speaks live to Jason Farrell, Senior Political Correspondent for Sky News, about the growing anger among MPs over last month’s Government-commissioned report on the pregnancy drug Primodos.

Severals MPs have joined the Primodos campaigners to say that the Expert Working Group review was a complete whitewash.

  • To download the Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Testsgov.uk.

House of Commons and House of Lords Debates

  • House of Commons’ talks ref “Hormone pregnancy tests“, 14 December 2017 – 15:20:54 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 10:40:26 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 17:53:45 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 13 October 2016 – 15:05:52 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 21 January 2016 – 11:06:20 parliamentlive.tv.

More About Primodos