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Up to one in 12 women unknowingly carry a genetic mutation that increases their risk of having blood clots when taking the Pill.
Everyone inherits two copies of a gene called factor V (F5) from their parents, which is vital for blood to clot properly in the event of an injury.
However, eight per cent of people have a mutated version that triggers a disorder called Factor V Leiden. While it causes no symptoms, it raises their risk of strokes, mini-strokes and deep-vein thrombosis.
If this group take the contraceptive pill, they are 35 times more likely to have a stroke compared to those who do not have the condition and do not take the Pill.
Simple blood tests can reveal if people have Factor V Leiden.
Yet experts insist a programme that would screen women before they take the Pill is not necessary, arguing that ‘very few blood clots would actually be prevented’.
This is despite a coroner issuing a warning to women on the Pill and doctors prescribing it, after two women who unknowingly had Factor V Leiden died from clots just 10 days apart while on oral contraception.
Simple blood tests can reveal if people have Factor V Leiden. Yet experts insist a programme that would screen women before they take the Pill is not necessary, arguing that ‘very few blood clots would actually be prevented’. This is despite a coroner issuing a warning to women on the Pill after two women who unknowingly had Factor V Leiden died from clots just 10 days apart while on oral contraception. In September 2021, Isabella Rangimohia Alexander, a 17-year-old from Auckland, became breathless and collapsed while on a walk with her father. After being transferred by helicopter to Auckland City Hospital, she was found to have clots in the blood vessels of her lungs. She died the following day after her condition deteriorated
The proportion of Brits taking oral contraceptives has fallen by more than two-thirds, from 420,600 in 2012/13 to 126,400 in 2022/23, according to NHS data. Around 555,400 women turned to the health service’s sexual and reproductive health services in 2022/23 — equivalent to four per cent of 13 to 54-year-olds
As Factor V Leiden causes no symptoms, clots are often the first indication of it.
Some clots do no damage and disappear on their own, while others are fatal.
While up to one in 12 women carry one copy of the gene mutation, fewer than one in 1,000 will inherit two — significantly raising the risk of clots, making it up to 80 times more likely.
Factor V Leiden is identified by a blood test that screens for the presence of ‘sticky’ blood.
Then, if the screening test is positive, the mutation can be specifically identified using a laboratory test.
Yet medics advise that lifestyle focused approaches would instead ‘save many more lives than V Leiden testing’.
This is because blood clots are most common among those who are overweight, smoke or spend a lot of time sitting down.
Neither the Royal College of Obstetricians and Gynaecologists (RCOG) or the US Centres for Disease Control and Prevention recommend routine screening given ‘the absolute risk remains low’.
Dr Channa Jayasena, a consultant in reproductive endocrinology at Imperial College London, also told MailOnline: ‘Lots of British women, up to one in 12, have V Leiden. But almost none of these women will ever have blood clots after the pill.
‘If we tested everyone starting the pill for V Leiden, tens of thousands fewer women each year would take the pill, but very few blood clots would actually be prevented.
‘Previous blood clot, smoking, obesity, cancer or immobility are at greatest risk factors for blood clots — smoking cessation and weight loss would save many more lives than V Leiden testing.’
Meanwhile, Dr Sue Pavord, consultant haematologist at Oxford University Hospitals NHS Foundation Trust and president-elect of British Society for Haematology said: ‘Whilst the relative risk of someone with Factor V Leiden developing a blood clot when they start the combined contraceptive pill is 35-times greater than for someone with neither of these factors, the absolute chance of a blood clot in these women is extremely low, at around 0.35 per cent.’
However, a US study published in September found that women with the Factor V Leiden gene and a handful of other gene mutations who take the Pill have a ‘high risk’ of developing blood clots.
Those with the highest genetic risk score were six times more likely to develop clots in the first two years of use, than women with a low genetic risk score.
Writing in the American Journal of Obstetrics & Gynecology, they said women at high risk should be identified and advised to try ‘alternative methods of contraception’.
It comes after a coroner last month issued a warning to women on the Pill and doctors prescribing it, after two women in New Zealand died in the same month from similar complications.
One of the women, Georgia O’Neill, a 24-year-old makeup artist, was found dead in her room at her shared flat in Auckland by her housemate in September 2021.
Just hours earlier, she had texted her roommate and father complaining of severe lower back and leg pain that made her want to throw up.
Post-mortem results revealed she had suffered a pulmonary embolism — a blood clot that blocks blood flow to an artery in the lungs — and unknowingly had Factor V Leiden.
The NHS says natural family planning can be up to 99 per cent effective when done correctly and around 75 per cent if not used according to instructions. By comparison, the Pill, implant, IUS and IUD are 99 per cent effective with perfect use, while condoms are 98 per cent
As of this month, women in England can now obtain a first prescription of the pill by visiting their local pharmacy. The move will give women greater choice over where to get the pill and forms a package of measures aimed at freeing up 10million GP appointments by next winter. If women opt for the combined oestrogen and progestogen pill, they will have a check-up with a pharmacist to record their blood pressure and weight
Prescription records also showed she was taking the combined Pill with ethinylestradiol with cyproterone acetate.
Also often taken as acne medication, the Medicines and Healthcare products Regulatory Agency (MHRA) — which polices the safety of drugs used in Britain — notes the combined Pill ‘substantially increases their risk’ of blood clots.
In another case in September 2021, Isabella Rangimohia Alexander, a 17-year-old from Auckland, became breathless and collapsed while on a walk with her father.
After being transferred by helicopter to Auckland City Hospital, she was found to have clots in the blood vessels of her lungs. She died the following day after her condition deteriorated.
According to a coroner’s report, she had been taking Levlen ED, a ethinylestradiol and levonorgesterel combined Pill, not to avoid pregnancy but to stop having her period.
According to a coroner’s report, Isabella Rangimohia Alexander (pictured) had been taking Levlen ED, a ethinylestradiol and levonorgesterel combined Pill, not to avoid pregnancy but to stop having her period. She was only made aware she had the Factor V Leiden mutation after molecular blood tests in hospital
The safety information leaflet included in Levlen ED pack warns the Pill should not be taken if you have a blood clotting disorder, such as Factor V Leiden.
But at an initial consultation with her GP about the Pill, Isabella had reported no family history of venous thromboembolism.
It was only after results of molecular blood tests taken in hospital showed she had the Factor V Leiden mutation, that she was aware of her condition.
Under the recommendations put forward by her coroner, women who take the combined Pill — even those with ‘no or few risk factors’ — and doctors must be informed about the seriousness of blood clots and symptoms to look out for.
The Faculty of Sexual & Reproductive Healthcare, part of the RCOG, estimates that around one per cent of women using the Pill are at risk of suffering fatal blood clots.
But Dr Pavord told MailOnline: ‘These were tragic cases — for most individuals, this genetic condition causes no problems at all.’
She added: ‘Rather than routine screening, and denying this excellent method of contraception to the 1 in 20 women who have Factor V Leiden, it is more important to counsel about risk factors for blood clotting and maintain a healthy weight, hydration and regular mobility of the feet and ankles to encourage good venous blood flow.’
A swathe of studies have found that implementing a mass screening programme would be of little benefit.
Writing in the journal, Fertility and Sterility, US researchers concluded that over 92,000 factor V Leiden carriers would have to be identified and stopped from using the Pill to prevent one VTE death, costing an estimated $300million (£236million).
‘Screening for Factor V Leiden mutation before prescribing combination oral contraceptives is not a cost-effective use of US health care dollars,’ they said.
In 1996, Dutch researchers writing in the BMJ claimed that implementing a screening policy ‘might deny effective contraception to a substantial number of women’ while preventing just ‘a small number of deaths’.
They added: ‘Were screening to be initiated, about 20,000 women positive for factor V would be denied oral contraceptives in order to prevent one death.’
Instead, they recommended taking a personal and family history of DVT when prescribing oral contraceptives over mass screening.
Meanwhile, an analysis of Australian studies on the risk of clots in women taking different types of combined oral contraceptives concluded it was ‘at worst, very small in absolute terms’.
Published in the Australian Family Physician in 2016, it added that clots ‘should not be the sole factor considered when choosing the “right” combined oral contraceptive for each woman’.
Known side effects of the Pill — proven to be over 99 per cent effective at stopping pregnancy — include nausea, breast tenderness, mood swings and headaches.
Rarer side effects of the combined and the mini pill, however, can include a slightly heightened risk of breast and cervical cancer.
Under plans laid out in full by the Government last month, women in England can now obtain a first prescription of the Pill by visiting their local pharmacy, giving them greater choice over where to get it.
Pharmacists were only previously permitted to dispense contraceptive pills — after they have been initially prescribed by a GP — and offer advice on different types of contraception.
But now they can now sign up for the new service to dish out contraceptive pills without patients having to go through general practice.
However, some experts have claimed that with access to the pill being opened up to many more women, the risk of rare side effects may increase.
But pharmacy chiefs hit back, arguing it’s national launch operates under ‘robust’ NHS guidelines with pharmacists required to undergo further training before offering the service.
Dr Leyla Hannbeck, head of the Association of Independent Multiple Pharmacies told MailOnline: ‘The wellbeing of patients is key for community pharmacists and they will be operating based on robust guidelines set by the NHS with regards to the contraception service, including a consultation with the patient before the pill is supplied.
‘Pharmacists offering this service have gone through additional training.’
‘The quality and risk assessment of the service will not be different to what it currently is via the GP practices.’
She added: ‘Offering this service through pharmacies does not necessarily mean that more women are going to be using the contraceptive pill compared to the current levels, but that more women will be able to see and speak with a healthcare professional about the contraceptive pill at a time convenient for them, freeing up GP time and helping clear up the backlog.’
Meanwhile, James Davies, the Royal Pharmaceutical Society’s director for England, said: ‘The pharmacy contraception service’s national launch aligns with established guidelines, and pharmacists are well placed to ensure the safe and effective use of contraceptives.
‘While we understand the concerns, we recognise the complexity of national screening criteria and commit to collaborative efforts with the Royal College of Obstetricians and Gynaecologists and the Faculty of Sexual and Reproductive Healthcare to provide reassurance and support for individuals taking oral contraceptives, ensuring a thorough and responsible approach.’