Noresthisterone period delay pill now sold over the counter : is it safe ?

What will be the real cost of “giving women more choices” and messing with their bodies” ?

“The Period Delay Pill has been available on our Online Doctor service previously and now introducing it in our pharmacies and nurse clinics with a consultation and questionnaire allows women to make the choice easily and quickly should they choose to delay their period.”

Michael Henry, healthcare director for Superdrug.

Reported Side Effects

Asthma; cardiac dysfunction; conditions that may worsen with fluid retention; diabetes (progestogens can decrease glucose tolerance—monitor patient closely); epilepsy; history of depression; hypertension; migraine; susceptibility to thromboembolism (particular caution with high dose).

When used for contraception

Active trophoblastic disease (until return to normal of urine- and plasma-gonadotrophin concentration)—seek specialist advice; arterial disease; functional ovarian cysts; history of jaundice in pregnancy; malabsorption syndromes; past ectopic pregnancy; sex-steroid dependent cancer; systemic lupus erythematosus with positive (or unknown) anti-phospholipid antibodies with intramuscular use for contraception disturbances of lipid metabolism; history during pregnancy of deterioration of otosclerosis; history during pregnancy of pruritus; possible risk of breast cancer.

Cautions, further information

A possible small increase in the risk of breast cancer should be weighed against the benefits.

The product literature advises caution in patients with history of thromboembolism, hypertension, diabetes mellitus and migraine; evidence for caution in these conditions is unsatisfactory.

Read NICE guidelines about norethisterone.

“Like the contraceptive pill, period delay pills are not side-effect free. Norethisterone is a synthetic version of the naturally occurring hormone progesterone and, like the other synthetic hormones in contraception, it can cause breast tenderness, nausea, headaches, low libido and, crucially, ‘disturbances in mood’. What the NHS likely means by this is mental health side effects which can range from ‘feeling a bit low’ to full-blown depression and anxiety. No two women are the same and so no two women will respond to a pill in the same way.”

Read Why no one’s talking about the worrying side effects of period delay tablets on Metro, 10 Aug 2019.

Evidence that intrauterine exposure to oral contraceptives might slightly affect pubertal timing

Pubertal development after unintended intrauterine exposure to oral contraceptives: a nationwide cohort study

2019 Study Abstract

Objective
To study the associations between exposure to oral contraceptives before conception and early in pregnancy and pubertal timing in boys and girls.

Design
Population-based cohort study.

Setting
Not applicable.

Patient(s)
Overall, 15,800 children (70%) born during 2000–2003 into the Danish National Birth Cohort were categorized according to maternal use of combined oral contraceptive pills or progestin-only pills reported around gestational week 17: no exposure (reference), exposure 4 months before conception, and exposure in early pregnancy. Children self-assessed pubertal status using Web-based questionnaires from 11 years and biannually throughout puberty.

Intervention(s)
None.

Main Outcome Measure(s)
Adjusted mean age differences (months) for attaining individual pubertal milestones and overall pubertal timing. Proportion mediated by prepubertal body mass index.

Result(s)

  • In boys, intrauterine exposure to oral contraceptives showed a tendency toward slightly earlier mean age for voice break (months, −3.8; 95% confidence interval [CI] −6.5, −1.0) and first ejaculation (months, −2.9; 95% CI −5.9, 0.1) and a mean difference of −1.4 months (95% CI −3.3, 0.4) for overall pubertal timing.
  • Girls with intrauterine exposure tended to have slightly earlier age at menarche (months, −1.9; 95% CI −4.0, 0.3) and Tanner breast stages and had a mean difference of −0.9 months (95% CI −2.7, 1.0) for overall pubertal timing.
  • Exposure before conception was not associated with pubertal timing. Prepubertal body mass index did not play a mediating role.

Conclusion(s)
This study shows some evidence that intrauterine exposure to oral contraceptives might slightly affect pubertal timing.

EWG Primodos review criticised for ‘not assessing risks properly’

Sky News’ Exclusive, 4 Apr 2019

“Somebody, somewhere, has performed a meta-analysis.
At some point, there was a decision not to include that in the EWG report.”

Oxford University professor Carl Heneghan has told Sky News the evidence against the pregnancy drug Primodos suggests a significant link between it and birth deformities (see below).

On 23 April 2019, during the Westminster Hall debate on the Expert Working Group report on hormone pregnancy tests, some MPs also questioned the methodology used and asked why not use meta-analysis to assess primodos evidence ? Some others clarified the difference between correlation vs causation (in ref to primodos link to births defects), or said : with pharma funding the MHRA, can the EWG report be fully independent ?

More information

  • 2018 Studies :
    • Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
    • The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, Nature, 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • Westminster Hall debate pack : CDP-2019/0095, 18 April 2019.

With Pharma funding the MHRA, can the EWG Report be Fully Independent ?

Westminster Hall debate, 23 April 2019

” Yes we had a (Primodos) review, but I’m not sure we can call that ‘independant’ “

Yasmin Qureshi MP calls into question the independence of the MHRA in its central role on the expert working group (EWG), for their report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy including possible birth defects.

Westminster Hall debate, 23 April 2019. Video reference.

More information

Primodos Link to Births Defects : Correlation vs Causation

Westminster Hall, 23 April 2019

“There is an association. The Minister must go from this room knowing that, because that is what the science shows.”

Edward J Davey MP clarifies how to correctly interpret Carl Heneghan’s study (see below). Video (above) reference.

More information

Expert Working Group Methodology Used for Hormone Pregnancy Tests Report

Westminster Hall, 23 April 2019

“When the data was pooled together properly it shows a clear association with several different forms of malformations. …
…The Expert working Group completely failed to use the right approach for systematic reviews”. …

Yasmin Qureshi MP questions the technique used by the expert working group, for their review, on the use of hormone pregnancy tests (primodos drug) and adverse effects relating to pregnancy including possible birth defects. Westminster Hall debate, 23 April 2019. Video reference.

More information

Primodos hormone pregnancy test drug tragedy : what exactly is being covered-up ?

Westminster Hall, 23 April 2019

Is it the legal side involving the NHS, is it the pharma industry influence on the official report, on the MHRA, is it the government wrongdoing, or is it a bit of everything that is being covered-up ?

Sir Mike Penning MP argues that the Expert Working Group review on Primodos was a “cover-up”. Reference.

More information

Why Was the Primodos Drug Withdrawn in The UK ?

Westminster Hall, 23 April 2019

“…attempts have been made to shift the blame on to women, to say that they did not want to be pregnant and used the tablet as an attempt to abort”.

Yvonne Fovargue MP reminds us that the hormone pregnancy test drug was not withdrawn for commercial reasonsReference.

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Did Bayer Schering use Millions of Women as Guinea Pigs for Profit ?

Westminster Hall, 23 April 2019

“1.5 million women, were treated as human guinea pigs for the pursuit of profit by the company Schering now Bayer”.

Hannah Bardell MP uses strong words such as “a criminal cover-up“, and reminds the minister and the government that the HPT drugs campaigners, MPs and primodos-victims are not going away… Reference.

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Why Not Use Meta-Analysis to Assess Primodos Evidence ?

Westminster Hall, 23 April 2019

Gordon Marsden MP calls for Expert Working Group / MHRA’s to use meta-analysis to assess evidence.

Gordon Marsden MP questions Expert Working Group / MHRA’s reluctance to use latest systematic review and meta-analysis to assess evidence, pointing out that the method is widely used by organisations including most recently by NICE and others through out the world. Reference.

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