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How One In TWELVE Women Carry Mutation That Increases The Risk Of Blood Clots When Taking The Pill... So Why DON'T Doctors Test For Genetic Quirk Before Dishing Out The ...
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.
WHAT IS THE FACTOR V LEIDEN MUTATION?The genetic mutation — inherited from one or both parents — is a variant of Factor V itself, a protein needed for blood to clot properly.
The first indication of the disorder may be the development of an abnormal blood clot. Some clots, however, do no damage and disappear on their own.
Experts suggest up to one in 12 women carry one copy the Factor V Leiden gene mutation.
Fewer than 1 in 1,000 will inherit two — significantly raising the risk of clots.
The mutation can affect both men and women.
Sufferers of factor V Leiden are also at greater risk of strokes, mini-strokes and deep-vein thrombosis.
The risk of blood clots can also be raised for those taking HRT.
But many often unknowingly live with the condition.
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 confirming the presence of the genetic mutation.
AdvertisementYet 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.'
Patient With Life-threatening Blood Clots Gets New Life
Vadodara: A 41-year-old man who had large life-threatening blood clots in both right and left pulmonary arteries got a new lease of life after undergoing mechanical thrombectomy (removal of blood clot from artery or vein) at a city-based hospital.The patient faced severe shortness of breath, fatigue and giddiness. He and his family were worried as medicines were not improving his condition. The 2D Echo and ECG revealed that the patient had elevated right-sided heart pressure suggesting pulmonary embolism. His CT pulmonary angiography indicated large blood clots in both his pulmonary arteries which if increased can prove fatal.After he was admitted to the ICCU at Baroda Heart Institute and Research Centre, he was given thrombolytic therapy, a clot-dissolving medicine, for 24 hours. Yet, his right-sided heart pressure did not reduce."The patient was very critical and required ventilator support. In such situations, pressure in the lungs rises, the heart starts failing and as the blood flow to the lungs gets reduced due to occlusive clots, the oxygen levels in the blood start falling to dangerous levels which become incompatible with life," Dr Parvindar Singh, an interventional cardiologist told TOI."Clots in the lungs needed to be removed urgently to save his life. Open heart surgery in such a situation carries a very high risk," said Singh, who along with the team of interventional cardiologists — Dr Mahesh Basarge, Dr Falgun Panchal, Dr Husain Bhatia, Dr Sagar Shah, Dr Sheshrao Pawar decided to undertake a high-risk life-saving intervention. Using a specialized device, special tubes were negotiated through the heart into the lung arteries and the clots were gradually sucked out of the main and the major branches of the pulmonary arteries."Patient underwent successful mechanical thrombectomy of pulmonary artery. During the procedure as the clots were removed his condition stabilized, oxygen levels improved, blood pressure stabilized, and he could be taken off ventilator support. He has now been discharged," said Singh.We also published the following articles recentlyMumbai: Timely intervention by conductor saves life of elderly passenger in BEST busArjun Lad, a conductor, showed presence of mind and saved the life of a 62-year old passenger in a BEST bus. The passenger, Rohidas Pawar, fainted and had a heart attack while traveling on route number 453. Lad rushed to his rescue and performed CPR. He then took Pawar to ESIS Hospital Thane for treatment. Due to Lad's timely intervention, Pawar's life was saved. The BEST plans to felicitate Lad for his actions, as several conductors were recently trained on CPR. As temp dips, uptick of patients with heart ailments, brain stroke at RimsThere has been an increase in the number of cases of brain stroke, cold and cough, and heart-related issues in Ranchi as winter sets in rapidly. The drop in temperature triggers an increase in blood pressure, making individuals more susceptible to heart-related issues. The state-run Rajendra Institute of Medical Sciences witnesses a surge in heart-related cases. Cold causes arteries to shrink and blood to thicken. Brain strokes surge in the morning due to nerve contraction. The golden hour is critical in saving a patient brought to the hospital on time. Arpora accident: Police await blood reports of Russian driverRussian national Anton Bychkov, who killed three Indian tourists in a car accident, is still undergoing treatment at GMC, Bambolim. The police have sent his blood samples for examination to determine if he was under the influence of alcohol or any narcotic substance. Bychkov is being treated for injuries and alcohol intoxication. The Indian tourists were leaving a pub when they were hit by Bychkov's car, which eventually plunged into a nullah. Bychkov and the owner of the car have been booked for culpable homicide.Statins Help Decrease Vein Blood Clot Risk In Women Taking Hormone Therapy
Hormone therapy is available to postmenopausal women to help alleviate some uncomfortable symptoms, such as hot flashes.
There are some potential risks to taking menopausal hormone therapy, a few of which center around the heart. These include a risk of stroke when hormone therapy is started later in menopause, as well as a higher risk of blood clots.
Now, researchers from the University of Texas Medical Branch have found that statin therapy may help lower the risk of venous thromboembolismm (VTE) or deep vein thromboembolism (DVT) — a condition that happens when blood clots form in the veins — in women taking menopausal hormone therapy.
The study was recently published in the journal JAMA Network Open.
Corresponding study author Dr. Susan C. Weller, professor in the Department of Population Health Science and Health Disparities at the University of Texas Medical Branch, noted the Women's Health Initiative results appeared two decades ago.
This means many clinicians have been reluctant to prescribe estrogen therapy because of the Women's Health Initiative finding that menopausal therapy caused women to have venous thromboembolism, she said.
"Venous thromboembolisms are potentially life threatening clots that can form in the arms and legs and may travel to the lungs," Dr. Weller told Medical News Today. "And indeed, oral conjugated equine estrogen — with and without progestin — is associated with (a) higher risk of possible clots."
In a previous study, Dr. Weller said she and her team of researchers found that transdermal estrogen — for example, the estradiol patch — with or without a progestogen was not associated with a higher risk for venous thromboembolisms.
"However, we found that women 50–64 years of age who took oral contraceptives, or birth control pills, whether for menopause symptoms or prevention of pregnancy, were at three times higher risk of venous thromboembolism than women on menopausal hormone therapy," she added.
Given that women suffering from menopausal symptoms may not be prescribed hormones because of clotting risks, Dr. Weller said it was important to find that there might be some hormonal options for menopause symptoms that are much safer than others.
"During our previous research on statin therapy, we learned what statin therapy can do. Systematic reviews indicate statins can reduce the risk for venous thromboembolisms as well as major vascular events. If statins generally reduce venous thromboembolism and hormone therapy raises that risk, the next step was a natural extension: what happens if you take both? Our new study tested whether statin therapy might reduce hormone-associated venous thromboembolism risk."
— Dr. Susan C. Weller, corresponding study author
For this observational study, Dr. Weller and her team examined data from almost 224,000 women ages 50 to 64 between 2007 and 2019.
Within this study participant pool, researchers reported almost 20,000 had recent hormone therapy exposure and about 36,000 had current statin exposure.
When analyzing the data, scientists found the risk of venous thromboembolism was 53% higher in women recently exposed to hormone therapy without current statin therapy.
They also discovered that venous thromboembolism risk dropped to only 25% in women recently exposed to both hormonal therapy and current statin therapy.
"Some types of estrogens may change the way that the body's natural clotting processes work, increasing the activity of clotting cascades," Dr. Weller said.
"Statins reduce venous thromboembolism and it isn't really clear how it happens, though the scientific evidence so far suggests it is related to decreased inflammation. What we do know, however, (is) that statins are generally well-tolerated, are widely prescribed for cardiovascular disease, and reduce the risk for major vascular events."
Based on the results of this study, Dr. Weller said it appears that if a patient has a reason that statin therapy would be recommended, it does not necessarily mean that hormonal therapy can't also be prescribed and that initiation of hormonal therapy early in the perimenopausal period may carry less risk than initiating in later years.
"The observed risk in our studies was lower than the rates observed in the large clinical trials two decades ago, but in those trials, the higher rates may have been due to the route of exposure (oral), the type of estrogen (conjugated equine estrogen), and the majority of women initiated hormone therapy after 60 years of age," she explained.
"(And) we would like to remind women and clinicians there remains the possible risk for breast cancer with hormone therapy and statins have not been shown to reduce that risk," Dr. Weller added.
"We invite clinicians to consider whether hormone therapy is right for their patients, given that the risks of venous thromboembolism may be lower with careful choice of type of estrogen, route of exposure, and statin therapy," she continued. "While venous thromboembolism risk may still be present with menopausal hormone therapy, that risk may be tolerable to patients and clinicians when compared to the alternative of suffering through hot flashes and other menopausal symptoms. High-intensity statins, particularly, appeared to reduce risk by about 30% in women taking hormone therapy."
— Dr. Susan C. Weller, corresponding study author
MNT also spoke about this study with Dr. Jennifer Wong, a board certified cardiologist and medical director of Non-Invasive Cardiology at MemorialCare Heart and Vascular Institute at Orange Coast Medical Center in Fountain Valley, CA. Dr. Wong was not involved in the research.
Dr. Wong said that studies like this not only reiterate the potential small risks of hormone therapy, but they offer preventive options for those who need to take hormone therapy.
"Hormone replacement therapy has long been known to increase the risk of blood clots, which for most people may not be clinically significant, but occasionally will lead to serious consequences," she explained.
"Statins have long been sought to decrease clot formation in both the veins and arteries likely by inflammation and adhesion of clotting factors along the vessel walls, so it makes sense that it can decrease your risk of venous thrombosis."
"[The next steps for this research should look] at women on hormone replacement therapy, who may not otherwise meet criteria to be on statin drugs, randomized to statin therapy or no statin, and then see if statin therapy decreases the risk for venous thromboembolism in women who may not otherwise have increased risk for cardiovascular disease."
— Dr. Jennifer Wong, board certified cardiologist
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