nuvaring blood clots

Fatal Blood Clot Precipitated by the NuvaRing

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Brittany Malone - Nuvaring precipitated fatal blood clot

We never expected that a simple decision, one that thousands of women make every day, would change our lives forever. The decision that our daughter made to use the NuvaRing as birth control seemed reasonable–it is a convenient method used by many women. If only we knew then what we knew now.

When the Crisis Started

It was Friday night like any other except that our 2 oldest daughters, Ashley (24) and Brittany (23) who graduated from Chico State the previous year, were driving up to visit their younger sister, Morgan (21) who was in her junior year at Chico State. The past 4 years my daughters shared the best of times together at Chico State. They were neighbors, played intramural sports together, volunteered together, attended adventure outings, shared friends, rode miles in Bidwell Park, shared clothes and simply hung out together as sisters do.

It was 12:30 a.m. on December 1, 2012 when my wife and I were awoken by 2 simultaneous phone calls. The first call came from our youngest daughter Morgan to my wife’s (Dana) cell phone which she keeps at her bedside every night. The 2nd call came to me from our eldest daughter Ashley to my cell phone. When my wife’s phone rang, she stepped out of our bedroom to take the call and I immediately could tell that something terrible had occurred. Ashley told me that she was calling from the hospital and that Brittany has been taken by ambulance to the emergency room after she her head rolled back suddenly and she stopped breathing at Morgan’s house.

We immediately threw some clothes on and left for Chico which is normally a 3 hour drive. I called the hospital and they said that they would have the head nurse in charge of the Neuro ICU call back as soon as she was able to give us an overview of Brittany’s situation.

I called Ashley and she explained that the 3 of them had gone out for the evening as planned even though Brittany was not feeling 100%. While they were out, Brittany was feeling “anxious” and said that she felt like her heart was racing, but she wasn’t sure if she wanted to go home or not because we suspect she didn’t want to disappoint Morgan by leaving early. Brittany then commented that the music was too loud so they decided they better go back to Morgan’s house so Brittany could relax. When they arrived back at Morgan’s’ house, Brittany sat on the couch while she drank a glass of water and ate a snack in hopes that she would relax and begin to feel better. Ashley and Morgan were sitting on either side of Brittany in an effort to help her feel at ease. A few minutes later Brittany’s head went back and she started gurgling and stopped breathing.

Ashley called 911 immediately and began to administer CPR to Brittany. The paramedics were dispatched and got there within minutes. When they arrived, Brittany was still not breathing so they continued CPR and used paddles to deliver electric shock a number of times with no luck. They inserted a breathing tube and then transferred Brittany to Enloe Medical Center where she was revived.

Ashley said that the nurse told her this was very serious and that we needed to get there ASAP. I assured her we would be up there as fast as my car would go. After hanging up with Ashley, we drove in silence for the next few minutes until my phone rang again. My heart sank as I realized that Brittany had been without oxygen for more than a few minutes, and while I didn’t know how long the brain could go without oxygen, I had a real bad feeling about this. I gave Dana a summary of the conversation that I had with Ashley and we drove in silence for the next few minutes until my phone rang again.

It was the head nurse from the Neuro Trauma Unit and she explained that Brittany had arrived at the hospital after suffering sudden cardiac arrest as well as respiratory failure with pulmonary hemorrhaging and was now in a coma in critical condition. She said that it was not clear how long Brittany had gone without oxygen before they were finally able to resuscitate her. The nurse made it very clear to us that this was very serious and that we needed to get to the hospital as soon as possible. For the next 2 hours we raced to the hospital in complete silence.

Trying To Figure Out What Was Wrong

When we arrived at the hospital, the Neuro ICU was full of Doctors and Nurses actively trying to save Brittany’s life. My poor daughters, Ashley and Morgan were completely traumatized by what they had just experienced with their sister. Then we met with a team of doctors that were struggling to understand why a perfectly healthy 23 year old woman could arrive at the hospital in her condition. They ask a series of questions like, does she smoke, do drugs, take prescription drugs, vitamins, herbs etc. Our answers were “no” just like her sisters had told them. About a couple hours later Dana remembered that she was on birth control, called NuvaRing. It’s seems like it’s a class all to itself…birth control…but it’s really a prescription drug. None of us thought anything of it at the time as Ashley and Morgan were also using the NuvaRing contraceptive device.

Toxicology reports came back immediately and were all negative. Over 40 blood tests were initiated to determine if Brittany had an autoimmune blood condition such as vasculitis or lupus that might be causing the pulmonary hemorrhaging. A number of these tests would take up to a week to come back, so a process called plasmapheresis was started in order to filter Brittany’s blood of any autoimmune cells that may have caused Brittany to hemorrhage. This process is similar to dialysis.

The First Hint Of A Blood Clot

As part of the preparation for the plasmapheresis process, a doctor attempted to insert a line into a deep vein in Brittany’s right leg, but he was unable to get it to feed into the vein due to a massive blood clot that was discovered. This was the first indication that the blood clot may be the root of a series of cascading events that led to Brittany’s condition. The doctors immediately removed the NuvaRing as they said it was likely related to the extensive deep vein thrombosis (DVT) in her right leg.

Once the blood clot was detected, the doctors suspected that a condition called Disseminated Intravascular Coagulation (DIC) had taken place. DIC is a condition that presents itself when the consumption and subsequent exhaustion of clotting proteins (soldiers in our blood that help the blood to clot) causes bleeding in other areas of the body. With Brittany, the clotting proteins were “used up” by the DVT in her leg which likely left the rest of the body depleted of the necessary clotting factors required to stop the bleeding in her lungs. In some cases like Brittany’s, the doctors explained that bleeding simply starts on its own without any injury due to how “thin” the blood becomes.

The doctors suspect the DIC event triggered the cascading effects which in turn lead to an acute onset Diffuse Alveolar Hemorrhage (DAH) causing blood to collect within the alveoli in her lungs. We were told that Brittany’s blood likely became so thin that it caused the blood cells surrounding her lungs to actually leak into her lungs and flood the alveoli. The alveoli are part of the lungs that are responsible for the exchange of oxygen in our lungs. These alveoli inflate and deflate with inhalation and exhalation. If enough alveoli are affected, gas exchange is disrupted and the brain is starved of oxygen.

The Fatal Consequences Of the Blood Clot

Here is a summary of the cascading events that we understand lead to Brittany’s death.

1. DVT – A large blood clot developed in a deep vein in her leg, which we believe was caused by the NuvaRing.

2. DIC – Disseminated Intravascular Coagulation. This condition occurs when the consumption and subsequent exhaustion of clotting proteins (soldiers in our blood that help the blood to clot) induces severe bleeding in other areas of the body. With Brittany, the clotting proteins were “used up” by the DVT in her leg which likely left the rest of the body depleted of the necessary clotting factors required to stop the bleeding in her lungs.

3. DAH – Diffuse Alveolar Hemorrhage. Blood began to weep into her lungs and into the clusters of alveoli which look like individual grapes in a bunch. The individual alveoli are tightly wrapped in blood vessels, and it is here that oxygen exchange occurs. When the blood leaked into the alveoli, her lungs began to fill up with blood instead of exchanging oxygen. Normally the oxygen-rich blood returning to her heart via the pulmonary veins is pumped back into systemic circulation. Unfortunately, the amount of oxygen flow diminished rapidly, effectively starving Brittany’s heart and brain from oxygen. This correlates with the “anxious” feelings that Brittany was describing to her sisters and her boyfriend. Her brain was not receiving enough oxygen, so it signaled her heart to beat faster and faster until she reached hypoxemic respiratory failure, had a heart attack, and lost consciousness.

4. This is when Brittany’s life began to quickly slip away. Unfortunately, the brain cannot survive more than 3 to 5 minutes without oxygen before brain damage begins. A scan of Brittany’s brain was done right after she arrived at the hospital and the initial results did not indicate any sign of brain damage, but the neurologist warned us that the results of hypoxia (lack of oxygen to the brain) don’t typically show up within the first 24 hours.

Over the next 2 days, the neurologist conducted a series of extensive neurological evaluations on Brittany to determine the extent of brain damage that had occurred. I watched each of these tests hoping for a sign of life, but instead, I felt like I watched her die over and over again. These testes were extremely painful to watch as the reality sank in that Brittany’s brain was seriously damaged. No parent should ever have to witness these tests, but I could not give up hope, so I watched until I my heart could take no more. Eventually I could no longer witness these tests. I will live with these horrific memories the rest of my life.

The doctor was preparing us for the worst case scenario which turned out to be true. Brittany had irreversible brain damage, and a final CT scan indicated brain death. He ordered a second opinion and the results were consistent with the first. We arranged for a 3rd opinion and held out hope as we were desperate to save her life. Our entire family was with us and we all prayed for a miracle, but unfortunately, our prayers were not answered. Our beautiful, healthy, sweet, responsible, funny and loving Brittany was gone forever…and there wasn’t anything I could do for her or for my other precious daughters.

Her death diagnosis was acute respiratory failure, diffuse pulmonary hemorrhage, diffuse venous thromboembolism with deep venous thrombosis, severe anoxic brain damage. We believe the blood clot (DVT) which was caused by the NuvaRing is the true cause of death. Without the clot, none of the events that followed would have occurred.

All of the tests that were conducted to determine if Brittany had some sort of an autoimmune blood condition came back negative, so this solidified our theory that the NuvaRing caused Brittany’s death.

True to form, Brittany continued her life journey of compassion all the way to the end. Five people around the nation were blessed with Brittany’s greatest gift of all…her vital organs. Her lungs are now breathing fresh air in North Carolina; her heart is beating strong in Texas and her kidneys, liver and pancreas were early Christmas presents to patients throughout the Bay Area.

Brittany was on the NuvaRing for 2 1/2 years and had just inserted a new ring the day before she stopped breathing. Brittany and all of us who loved her are now robbed of what could have been.

We have formed a parent group to help educate women on the serious and real side effects of the NuvaRing birth control device and help share the information they need to make a more informed decision based on a combination of safety, efficacy and convenience. Not a week goes by without being contacted by a young woman or a parent whose lives have been seriously impacted by a death or near death due to what they believe was a side effect of the NuvaRing.

How many young women have to die in order for something to be done?

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

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Blood Clots With Hormonal Contraception

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blood clots with hormonal contraceptives

Over 80 percent of American women use hormonal contraception at some point in their lives. Many women who have taken birth control pills, or used other hormonally-based birth control methods such as implants, patches, vaginal rings, and hormone-emitting IUDs are probably familiar with the common side effects like fatigue, loss of libido, mood effects, headaches and breast pain. However, many women may not be aware that taking almost any form of hormonal contraception increases their risk of developing blood clots, a condition that can range in severity from asymptomatic to fatal.

The risk of developing a blood clot varies depending on the type of hormonal birth control used. One might assume that the newer methods would be safer, but in fact, they are more dangerous. The newer birth control pills (formulations containing drospirenone, desogestrel, gestodene and dienogest) confer a higher risk of blood clots than older formulations (containing norethindrone acetate or levonorgestrel, as well as the newer norgestimate). And the risk from patches and vaginal rings are the highest of all. It seems that regulatory agencies are willing to lower safety for the sake of user convenience, something that most women using hormonal contraception probably would not agree with, if they knew they were being put at risk.

The overall risk is considered low, with about 1 in 10,000 reproductive age women per year developing a blood clot. However, the older birth control pills increase the risk by about four-fold, and the newer birth control pills by five to seven-fold compared to non-users of hormonal contraception. There has been a substantial increase in the incidence of blood clots for the period of 2001 to 2009, compared to the years prior, likely because of the increase in use of newer hormonal birth control pills and the vaginal ring (Nuvaring). And because approximately 20 million American women use hormonal contraception, these relatively small risks translate into significant numbers of cases each year.

Every woman who is using hormonal contraception deserves to know accurately what the risks are, in order to make an informed choice of method of contraception, yet these risks are not often being communicated by doctors. And considering that taking any form of hormonal birth control at all raises the risk of developing a blood clot, every woman on hormonal contraception should know what the warning signs are, and seek medical help if they experience those signs or symptoms. Knowing these warning signs could save your life. Described below are signs of blood clots in various locations in the body.

Blood Clots In Legs, Arms, and Lungs

Blood clots can develop in any vein but most commonly develop in the leg, and sometimes in the arm. This type of blood clot is called a venous thromboembolism (VTE). These clots can break off from the spot where they initially form in the body, and travel to the lungs, causing a pulmonary embolism (PE), which is fatal in about 10 percent of cases within the first hour, and 30 percent of cases subsequently. Sometimes the VTE leading to the pulmonary embolism was asymptomatic or undiagnosed, and PE is the first indication of the presence of a blood clot. Even pulmonary embolism is often misdiagnosed at first.

Signs of VTE include pain or tenderness only in one leg or arm, swelling and/or red or blue discoloration of the affected limb or an area of the limb, and the leg or arm may be warm to the touch. Signs of a PE include sudden shortness of breath, chest pain that is sharp or stabbing and may get worse with deep breathing, rapid heartbeat, and cough (sometimes with bloody mucous). For information about how VTE and PE are diagnosed, see How is DVT Diagnosed? and How is PE Diagnosed?.

Blood Clots In the Veins of the Brain

Cerebral venous thrombosis (CVT), which is a type of stroke, is caused by blood clots in the veins of the brain. This condition is even more under recognized than DVT and PE, and comprises about one percent of all strokes. Using oral contraceptives has been shown to increase the risk of CVT up to 22-fold. This study is on the older side, performed before more widespread use of newer birth control pills, so the risk is likely even higher. In the past, this condition was fatal much more often, but now the diagnosis has been improving, and the mortality in various studies ranges from 5 to 30 percent. About 15 percent of patients who survive can have continued neurological impairment. CVT can be diagnosed using a combination of clinical signs and symptoms, and imaging such as MRI.

Signs and symptoms of CVT can vary depending on where the clot is in the brain. Headache is a common symptom, sometimes accompanied by nausea and vomiting. Seizures can also occur. In addition, neurological problems can be present, such as: paralysis or weakness on one side of the body, decreased vision on one side, difficulty speaking, or dizziness.

Blood Clots In Arteries

Like in veins, blood clots can form in almost any artery in the body. And similar to venous blood clots, clots that initially formed in one artery can break off and travel to arteries within almost any organ in the body. A blood clot in an artery in the brain causes a stroke (just like a blood clot in a vein in the brain), and a blood clot in an artery in the heart causes a heart attack. Hormonal contraception also increases the risk of these types of blood clots. In some cases larger strokes are preceded by smaller strokes, called transient ischemic attacks (TIA)—this occurs when a blood vessel is blocked temporarily by a blood clot. The incidence of stroke has increased significantly, especially in young people, from 1995 to 2008.

Symptoms of strokes caused by a blood clot in an artery are similar to those described above for CVT. Early treatment of a stroke results in significantly better outcomes; therefore the American Heart and Stroke Association has developed the following acronym to help people recognize the early warning signs: F.A.S.T.

  • F: Face drooping
  • A: Arm weakness
  • S: Speech difficulty
  • T: Time to call 911.

Warning signs of a heart attack in women include:

  • Chest pain—can feel like uncomfortable pressure, squeezing, fullness or pain in the center of the chest.
  • Pain or discomfort in one or both arms, back, neck, jaw or stomach.
  • Shortness of breath with or without chest discomfort.
  • Nausea, light-headedness, or breaking out in a cold sweat.

It should be noted, that women may experience the signs of a heart attack differently than men and diagnosing heart attacks in women is sometimes more complicated requiring great persistence on the part of the patient and the family. An example of this can be found here.

Other Factors That Increase Risk

An individual’s risk of getting a blood clot depends on a combination of genetic factors, acquired conditions, and environmental/lifestyle factors. Although many women may be familiar with the oft-cited risk factors of being overweight, smoking, and being over age 35, many women might be surprised to realize that some of the seemingly innocuous factors described below, or undiagnosed genetic conditions, can combine to increase the risk substantially.

Genetic Factors

Certain inherited conditions, known as inherited thrombophilias, can increase the risk of developing a blood clot. Many people with these inherited conditions have no signs or symptoms of a blood clotting disorder until an environmental or acquired risk factor or factors comes into the picture (such as a hormonal contraceptive), at which point their risk of developing a blood clot increases substantially. These inherited thrombophilias include antithrombin deficiency, protein C deficiency, protein S deficiency, Prothrombin (factor II) mutation, factor V Leiden mutation and hyperhomocysteinemia (which can be caused by MTHFR mutation). The effect of the increased risks from hormonal contraceptives and inherited thrombophilias is synergistic, meaning the risk is much larger than the risk of the two added together; for example, in hormonal contraceptive users carrying a factor V Leiden mutation, the risk of a blood clot is increased 35 fold. Inherited thrombophilias can be detected by genetic testing, but are not routinely screened for. More information about inherited thrombophilias can be found on the National Blood Clot Alliance website.

Acquired Conditions

The acquired condition that is most commonly associated with an increased risk for blood clotting is an autoimmune condition called anti-phospholipid syndrome (and less commonly anti-cardiolipin antibodies, or anti-B2 glycoprotein 1 antibodies). These antibodies can occur on their own, in the absence of other autoimmune diseases, or they can occur secondary to autoimmune diseases such as lupus. These conditions can cause other symptoms in addition to blood clots, such as miscarriage and migraine. Cancer, especially metastatic cancer, is also a recognized risk factor for thrombosis. Hyperhomocysteinemia can also be an acquired condition due to nutritional deficiencies, some chronic illnesses, and medications. Chronic inflammatory conditions such as Crohn’s disease also increases the risk of blood clots.

Environmental or Lifestyle Factors

Certain lifestyle factors are also known to increase the risk of blood clots, including:

The risk of developing a blood clot also increases with increasing age.

It must be stressed that one does not need to have a genetic or acquired risk factor to develop a blood clot, or even to have a fatal blood clot. Following are just a few of many stories of young, healthy women who were seriously affected or died from blood clots while on hormonal contraception.

These women unfortunately did not realize that their choice of birth control was putting them at increased risk. For these women, knowing that they were at increased risk, and knowing the warning signs of a blood clot, could have saved their lives. That is why we are urging all women to become aware of these warning signs, investigate your personal risk, make smart, informed choices of birth control methods, and seek medical attention immediately if you are experiencing signs of a blood clot.

In Memory

This article was inspired by and written in memory of Karen Langhart, who tragically took her own life four years after her young, healthy, vibrant daughter Erika, died suddenly from bilateral massive pulmonary embolisms caused by the Nuvaring. Since Erika’s death, Karen had worked tirelessly to ensure that other families would not suffer the tragedy that hers did.

Hormones Matter will be covering this important topic in more detail in the coming months, so please follow this website, or follow us on Facebook and Twitter at and @HormonesMatter. If you have experience with contraceptive induced blood clots and would like to contribute a personal story or research article, please consider writing for Hormones Matter.

Image by starline on Freepik

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Deadly Blood Clots from the NuvaRing: Erika’s Legacy

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Erika's Legacy

Erika Langhart was planning to make a difference in the world.  She was never given that chance.

At just 24 years old Erika was struck down by a massive, double pulmonary embolism (blood clots that had traveled to her lungs), as a direct result (per her pulmonologist) of the NuvaRing.  Investigative journalist, Marie Brenner, wrote an in-depth report (“Danger in the Ring”) for Vanity Fair magazine about Erika and her classmate at American University, and Olympic Athlete, Megan Henry regarding the dangers of this drug.

CNN Anderson Cooper 360 was subsequently inspired to air a special report: Families, lawsuits, raise questions about NuvaRing.

It is our greatest hope, with what remains of our lives, to fulfill our daughter’s goal of making a difference in the lives of others by helping to inform women about the dangers of not only the NuvaRing; but all hormonal contraceptive drugs – the pill, patch, ring and implants. We believe women deserve to be informed of the full truth about these powerful drugs.

Erika Langhart’s Case for Wrongful Death was dismissed on September 10, 2015 because we refused to settle with Merck.  We never agreed to anything other than having her case heard in front of a jury for the purpose of exposing the truth about the NuvaRing and Merck.  Following  is our statement read to the Superior Court of the State of California for the County of San Francisco, NuvaRing Products Case #CGC-12-520371.

We were promised that Erika’s case would be filed in the state of Virginia, via the rocket docket, for a jury trial by the end of 2012.

We can only imagine the outcome had this promise been kept. We believe the truth about this drug, and Merck, would have been exposed through this trial and hundreds of women’s lives since 2012 would have been saved. We now have the very dubious honor of being friends with the parents of many of the young women who, unnecessarily, lost their lives to this drug.  We hope you try to imagine what that is like for a moment…we can assure you there is nothing more painful to endure than losing a child to, what we view, as murder.

How you were able to convince/coerce the FDA into changing the NuvaRing label to a WEAKER label in October of 2013, all while more and more reports of injury and deaths were being filed with the FDA’s own MedWatch is stunning…and disgusting.  Of course by doing so, you have effectively shut down all legal avenues for women who have been injured or who have lost their lives to this drug…

So, Congratulations!…however, we believe Justice will eventually reach you.

May God have Mercy on your souls for allowing, and helping, these tragedies to continue. You are putting money and profits before the very lives of innocent young women – we do not know how you sleep at night…as, we believe, you will certainly, eventually, meet your deserved justice on your own judgment day.
How you are able to defend Merck, and other members of these legal (and we use this word loosely) drug cartel corporations, is beyond us and perhaps you would do well do pay heed to the words of Dr. Benjamin Rush – a signer of the constitution and George Washington’s physician….

“Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship…To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic and have no place in a republic. The Constitution of this republic should make special privilege for medical freedom as well as religious freedom.”   – Benjamin Rush, MD.

You are, in our opinion, facilitating the dangerous, and by principle un-Constitutional, Medical Industrial Complex through your actions…which is unnecessarily taking the lives of an untold number of American citizens, all in the name of Greed.

Merck’s “official statement” in response to being questioned about the danger of the NuvaRing follows:

“Blood clots have long been known as a risk associated with combined hormonal contraceptives. The FDA approved patient information and physician package labeling for NuvaRing include this information. We remain confident in the safety and efficacy profile of the NuvaRing – which is supported by extensive scientific research – and will continue to always act in the best interest of patients,” as published in Vanity Fair.

A more truthful statement of risk might read something like this: (our additions to their statement are in bold)

“Blood clots have long been known as a risk associated with combined hormonal contraceptives”.

We cannot explain, except by pure greed, why these drugs continue to be given to women when there are safe and effective alternatives for Birth Control available.

“The FDA approved patient and physician package labeling for the NuvaRing include this information”,

as negotiated by our highly paid consultant, and former FDA administrator of the Women’s Health division, Dr. Susan Allen, for the benefit of Merck.

“We remain confident in the safety and efficacy profile of the NuvaRing – which is supported by extensive scientific research” –

Paid for by us with expected outcomes supportive of future profits from the NuvaRing but ignores the independent, unbiased, extensive scientific research conducted by Dr. Lidegaard which does not support future profits for Merck from the NuvaRing –

“and will continue to always act in the best interest of patients”,

which we have to admit is a lie as evidenced by our track record with many of our other drugs such as Vioxx.

Congratulations on the continued growth of Merck profits for the NuvaRing at the expense of women’s lives; $723 million last year (K-10 report), alone, achieved in conjunction with the injury and death of hundreds, if not thousands, more women who are apparently just “acceptable risk factors” to Merck.

A $100 million dollar settlement was really a bargain for you to keep these kinds of sales going – the settlement even helped increase sales for Merck! Unbelievable, and criminal, in our opinion.

These words have been spoken in honor and memory of our beloved daughter Erika and the thousands of other young women who have unnecessarily been injured, or have had their lives taken, by Merck’s drug – The NuvaRing.

We would like to note that the judge in this case said that he was truly sorry and could not imagine this kind of loss of life.

Readers  may be interested in viewing a short video by Dr. Peter Gotzsche regarding Big Pharma operations.

Real Risk Study: Birth Control and Blood Clots

This story is one of a series about women who have developed blood clots while using hormonal contraception. These articles are part of the Real Risk Study: Birth Control and Blood Clots, a research project to help women gauge their actual risk with hormonal birth control. For more information, or to participate click here.

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Five Half-truths of Hormonal Contraceptives – The Pill, Patch and Ring

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Brittany Malone - Nuvaring precipitated fatal blood clot

Have you ever wondered if the pharmaceutical companies and doctors are telling you the whole truth about the risks for side effects with the drugs they sell or prescribe? Do the side effect warnings seen in advertisements or on prescription inserts make any sense to you? If you are like me, probably not. In fact, if you’re like me you probably don’t give side effects much thought at all. Or at least I didn’t, until my daughter suffered from a serious side effect of a common medication, a medication millions of women take every day for years. My daughter died last year from hormonal contraceptive induced blood clots. You can read her story here: Brittany Malone. Now, I have made it my mission to educate other women and families about the very real risks associated with hormonal contraceptives and the incredible lack of data and information available to women to make an informed choice.

Playing Fast and Loose with the Numbers: Hormonal Contraception Carries Real Risks

For too long, the pharmaceutical industry and most likely your doctor, have been telling you what they want you to know about birth control drugs; instead of educating you with the information that you need to know to help you choose the birth control method that works best for you.

The communication of risk and benefit is a core component of health care counseling and should begin with the most fundamental principles of medicine: “First, do no harm.” I am not sure that is what is happening now. It didn’t with our daughter and many of the women and families we have met who have suffered similar tragedies.

What women really need to know is how a particular contraceptive drug or method compares to other types of contraception in terms of safety and effectiveness. In more personal terms, you need to know what the chances are that a particular contraceptive formulation or device will adversely affect your health. What I have learned since my daughter’s death is that this information is not easy to come by. In fact, it either doesn’t exist entirely or the manner in which it is presented is so convoluted that it is indecipherable and utterly useless.

The terms used by pharmaceutical companies as well as some leading contraception experts to describe these risks are either gross simplifications of the actual risk to life, or are enveloped in complex statistical and/or medical jargon that the lay person and even the physicians prescribing these meds cannot understand.

Here is what I mean. Below is a list of the most common half-truths regarding hormonal contraceptives and the risk for deadly blood clots.

Half-truth # 1: Blood Clots with Combined Hormonal Contraceptives are Rare

The increased risk of developing a dangerous blood clot when using combined hormonal contraceptives (CHCs) is a well-recognized, serious and potentially fatal adverse event associated with these medicines. A recent study published in the British Medical Journal (abstract) says there are even higher rates of blood clots than previously thought see Fresh Evidence Confirms Links between Newer Contraceptive Pills and Higher Risk of Venous Thromboembolism.[1] Unfortunately, most patients are unaware of this potential risk and if they are aware, they have no idea that a blood clot “cardiovascular event” can lead to their death. More studies can be found here on Birth Control Safety.  Any time a drug is prescribed that is proven to cause death, even if it is associated with a small percentage of the users, the provider is responsible for explaining the risks factually, and in terms a lay person can understand. Consider these data:

  • On average, 307 women die in the U.S. every year due to a pulmonary embolism (blood clot in the lung) as a direct result of the use of the pill, patch or ring – a combined hormonal contraceptive.
  • Up to 2,600 women in the U.S. will develop a pulmonary embolism (blood clots in the Lung) as a result of the pill, patch or ring. Pulmonary emboli are potentially catastrophic and can lead to death.
  • Up to 7,700 non-fatal cases of deadly blood clots in the U.S. occur each year, due to the effects of the pill, patch or ring.

If you are like most doctors and all patients, you will be shocked to learn how many women are harmed annually by hormonal contraceptives.

For a full report, see Birth Control Safety.  This report compares the estimated impact of blood clots across 2nd, 3rd and 4th Generation Combination Hormonal Contraceptives.

Unfortunately, most doctors leave their patients believing that combined hormonal contraceptives (the pill, patch and ring) are safe. As you can see from the data stated above, these drugs are safe for some people and very dangerous for others.

Half-truth #2: Only Smokers and Women Over 35 are at Risk for Blood Clots

The reality is that the estrogenic effects of combine hormonal contraceptives increase the risk of a potentially life threatening blood clot (venous thromoboembolism or VTE) by between 400% – 700% for ALL women at any age including those that don’t smoke and those that do smoke.[2] (Comparing Annual VTE Impact across 2nd-4th Generation CHC’s in the U.S. 2013). The risk of smoking increases that risk by 40% compared with non-smokers [3]. That means, the increased risk of blood clots effects all users by 400-700% and the risk associated with smokers and for women over the age of 35 is even higher. This form of warning is misleading as many who read this think, “I don’t smoke and I’m under the age of 35, so this cardiovascular risk doesn’t apply to me. I’m safe to use it.” Even worse, this false sense of security is proven to mask the early warning signals of a potentially deadly blood clot.

The following is included as a “black box” warning in the most recent version (2013) of the NuvaRing patient information and reads as follows:

“Who should not use the NuvaRing?” Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination oral contraceptives. This risk increases even more if you are over age 35 and if you smoke 15 or more cigarettes a day. Women who use combination hormonal contraceptives, including NuvaRing®, are strongly advised not to smoke.”

This statement infers that if you are a non-smoker and under the age of 35, that you should be able to safely use the NuvaRing. It also infers that if you are a smoker, even though you need to be concerned, you don’t need to be too concerned unless you smoke 15 cigarettes a day AND are over 35. This is misleading; intentionally misleading, I think.

In the same 2013 NuvaRing package insert, under the heading “What is the most important information I should know about the NuvaRing? Comes the answer:

“Do not use the NuvaRing if you smoke cigarettes AND are over 35 years of age. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination hormonal contraceptives (CHC’s), Including death from heart attack, blood clots or stroke. The risk increases with age and the number of cigarettes you smoke.”

Again, I think this statement falsely misleads women who do not smoke about their risks for blood clots. A more appropriate warning label might say something like this:

The estrogenic effects of combined hormonal contraceptives increase the risk of potentially life threatening blood clots by between 400% – 700%.

Hormonal Contraceptive Risk Counseling Misses Real Risks

Below are three videos that exemplify the lack of appreciation physician give to the real risks of blood clots with hormonal contraceptives. These are videos used to train physicians, nurses, pharmacists and other healthcare practitioners.

The Contraceptive Counseling Training Video below is a perfect example of how doctors and nurses are being taught to promote the effectiveness and safety of the pill, patch and ring without counseling women on the fact that these drugs to cause great harm, even death to some users.

Contraceptive Counseling Training Video

I find it very interesting that time is taken to review the side effects of spotting, bloating, nausea and breast tenderness, but the discussion of the dangerous side effects like blood clots, strokes, heart attacks which can lead to death don’t even come up. This has to change. Given the reoccurring annual loss of life attributed to these drugs, the true risks and early wanting signals of a dangerous blood clot need to be reviewed and thoroughly understood.

This next video is a great example of a typical visit with a nurse practitioner can unfold with zero safety information being shared relative to the increased risk of blood clots. Even worse, the question is asked “do you smoke at all,” and when the patient says I used to smoke and the nurse responds with the doctor’s advised you that you shouldn’t smoke while using the pill, the patient responds with yes. This is a great example of how the pharmaceutical companies have brainwashed doctors and nurses to highlight the risks associated with smoking, which leave a non-smoking patient to believe they are not at all exposed to any increased risk of developing a potentially catastrophic blood clot.

Brenda Oral Contraceptive Pill Counseling

In this final video, a patient shares that she smokes 10-15 cigarettes a day and the recommendation of the doctor/nurse is as follows “I’ve reviewed your family history and is it quite safe for you to take the pill. What I suggest is that you take the combined oral contraceptive pill. This is an example of the clinical issues that are putting our loved ones and friends’ lives at risk. Given that the increased risk of blood clots with CHC’s is well recognized, serious and potentially fatal, this practice of uninformed counseling is dangerous and needs to change before more women are killed.

A Contraception Consultation in Pharmacy

In each of these practitioner training videos, the real risks for blood clots associated with hormonal contraceptives is minimized. Women are not given the data needed to make informed decisions. As a result, when these risks turn to reality, they often go unrecognized. There are hundreds of stories of young women that were perfectly healthy and didn’t smoke that died suddenly from massive blood clots linked to the pill, patch and the ring. Birth Control Safety: Women’s Stories.

Half-truth # 3: All Hormonal Birth Control Methods are Equally Safe

Evidence confirms that newer contraceptive drugs have a higher risk of blood clots. In fact, the 3rd and 4th generation contraceptives (Yasmin, Yaz, Ocella, NuvaRing etc.) increase the overall risk by an additional 200% – 300%, above and beyond the risk for blood clots associated with earlier formulations. I think women should know this before choosing a method of contraception. I think physicians should make this information very clear to their patients. Unfortunately, I don’t think this is happening. Most patients and physicians alike do not understand the different risk profiles that each formulation of hormonal contraceptive carries. Prescribers especially should be aware and consider how the risk of blood clot with a particular combined hormonal contraceptives compares with other methods (see table 1) and help their patients make informed decisions. Currently available data provides compelling evidence that both 3rd and 4th Generation CHCs have higher risk of venous thromboembolism (see table 1) than the older 2nd Generation drugs, despite attempts to develop safer contraceptives for women.

Table 1. Risk for Blood Clots with Different Hormonal Contraceptives

Table 3- Comparing Annual VTE rate

Half-truth # 4: Blood Clots are more Common During Pregnancy and Postpartum

Pharmaceutical companies maintain the enormous market for hormonal contraceptives by telling doctor’s and women that it’s safer to use the pill, patch or ring than it is to get pregnant. This is a false comparison and here’s why. These dangers are of an unnatural substance interfering with body processes. Pregnancy however is a natural process, which the body is prepared to deal with. The pill, patch or eing actually introduce cardiovascular disease (blood clot) into your body (Confessions of a Medical Heretic, p29)[4]. Women who have already made the decision to use contraception have taken pregnancy off the table, so the real question is, how does the pill, patch and the ring compare to other forms of contraception in terms of both safety and effectiveness?

Women in the U.S. have on average of 2 births in their lifetime. The risk of these two period of life, pregnancy and postpartum periods, that total 30 months of time, cannot be compared to the risk that a women experiences while using a combined hormonal contraceptive continuous over the course of their child bearing years which may be as long as 25 years. This type of comparison (that the risk of a blood clot or other complication is many times greater during pregnancy), defies both logic and science. Comparisons of contraceptives should be between the various methods of birth control as this helps women make the most informed decision of which method of birth control works best for them. They have already made the decision to control birth (not get pregnant), so there is no need to compare these drugs to pregnancy.

Pregnant women often pay more attention to their bodies because they are concerned about their own health and the health and safety of their unborn child. Medical professionals more closely monitor pregnant women than hormonal contraceptive users. The identification of a venous thromboembolism is more likely to occur in a pregnant woman, as she has more frequent contact with the medical community. When a healthy woman is prescribed birth control, there is a “set it and forget it” treatment plan where the health provider may say, “Call me if you have any problems and come back in a year.”

This false comparison of risk of VTE in pregnancy versus the pill, patch and ring creates a false sense of safety with hormonal contraceptives compared to pregnancy. It minimizes the possibility that something terrible could happen while using a combined hormonal contraceptive. This is like warning someone to watch out for the charging elephant but failing to pay attention to the charging buffalo. Yes, an elephant’s foot may be bigger and heavier, but if a buffalo charges you will still have a problem.

The oversimplified and inappropriate presentation of the risk during pregnancy minimizes the increase rate of risk between 2nd, 3rd and 4th generation combined hormonal contraceptives. Newer is not better. In fact, the newer 3rd and 4th generation drugs increase the life threatening risk of blood clots and bring no incremental benefits outside of expanded choice.

Half-truth # 5: Double a Rare Event is Still a Rare Event

Healthcare professionals need to stop using that phrase “Double a rare event is still a rare event” when it comes to women’s lives. This is a statistical view of the mathematics that make up traditional risk management practices that minimizes the very risk of serious side effects, including fatality, associated with these medications. Even if these side effects develop in a small percentage of the users, the patient needs to understand these risks and it is the provider that is responsible for explaining the risks factually and in context that patients can comprehend.

In reality, if we double the rate of venous thromboembolism and pulmonary emboli, the number of related deaths grows from an average of 307 to 614 per year. The number of women impacted by the most dangerous type of blood clot, a pulmonary embolism, which has a 12% mortality rate, grows from an average of 2,560 to 5,120 women annually. Pulmonary embolism survivors are subject to additional treatment, which typically includes anticoagulant medications (blood thinners) and varies in type of treatment and duration based on severity. Some women need immediate emergency treatment, others can be treated as an outpatient. Patients are typically treated for 3-12 months, but some must remain on blood thinners for extended period of time.

As you can imagine, this dismissive, although witty, statement does not attune the health care community to pay serious attention to the possibility that real people will die or be permanently injured. Furthermore, when you multiply a small number by a large number of users the impact of these “rare events” equates to many more deaths than anyone realizes. Rare events DO happen and they happen to real human beings! It is also an insult to the thousands of women (and their families) who have been injured or died particularly when there are much safer and more effective alternatives available

The Bottom Line: Hormonal Contraceptives Carry Significant Risks

FACT – Combination hormonal contraceptives dramatically increase the risk of dangerous blood clots.
FACT – Blood clots (acute thrombotic events) are known to lead to sudden death or lifelong problems.
FACT – Pulmonary embolism (blood clot in the lungs) are the most dangerous form of thromboembolism which has a 12% mortality rate.
FACT – 20%-25% of pulmonary embolism related deaths present as sudden death (No Warning) [5].
FACT – A woman is 20 times more likely to become pregnant if she uses birth control pills, a patch or a ring than if she uses an IUD or an implant [6].

References

  1. Jick S, Fresh evidence confirms links between newer contraceptive pills and higher risk of venous Thromboembolism BMJ 2015;350:h2422 doi: 10.1136/bmj.h2422 (Published 26 May 2015).
  2. Comparing Annual VTE Impact across 2nd-4th Generation CHC’s in the U.S. 2013 – Birthcontrolsafety.org).
  3. Goldhaber S, The Clot Blog of Medscape.com, VTE risk in women who smoke; http://www.medscape.com/viewarticle/801689 last sourced 9-15-2015.
  4. Mendelsohn S, Confessions of a Medical Heretic, Chapter 2, page 28.
  5. Beckman M, Hooper WC, Critchley S, Ortel T. Venous thromboembolism: a public health concern. Am J Prev Med. 2010;38(4 Suppl):S495-501.
  6. American College of Obstetricians and Gynecologists, Frequently Asked Questions FAQ#184 Contraception: Long-Acting Reversible Contraception (LARC): IUD & Implant.

Related posts:

No knowingHormonal Contraceptives: Do We Really Know What We Think We Know? testing for clotting disordersWhy Aren’t Women Tested for Factor V Leiden and Other Clotting Disorders?

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