nuvaring

Julia’s Story: NuvaRing Induced Disseminated Intravascular Coagulation

2367 views

Julia Ruth West Ross (1983-2013)

Julia, our middle daughter, lived in Southern California while earning an M.A. in Economics at UC Irvine. She enjoyed Southern California because there was so much she liked to do there.  She loved camping, beach trips, Mexican food, music concerts, hanging out with friends, beer tasting, and her two cats.  She started working at her first professional job in 2011 and she then met her husband Eric. Julia and Eric had just married and were so excited to be in their new apartment and all of us were so happy for them. It was a wonderful time.

Julia called me on Tuesday night on her way home from work. She was looking forward to the upcoming weekend as she was getting things packed for their delayed honeymoon cruise that coming Sunday. She was so happy.

Eric and Julia were married for just under five weeks when I got a call two days later from Eric that Julia was in the Emergency Room.

Early Signs of NuvaRing Clotting

Eric told me that Julia had been feeling tired for a few days, but that on Wednesday night, as she walked to her car after work, she felt faint, had tunnel vision and was short of breath. She got home and climbed into bed early. Usually full of energy, this was not like Julia, and Eric was surprised when he came home from work to find the house dark and Julia in bed. She told him she felt really tired and nauseous. He later told us that night “she threw up once or twice but it was mostly just dry heaving with just a little bit of liquid, the liquid though was very dark. Also, she had not eaten very much the last few days. I don’t remember the exact details but I think she had hardly eaten the day before and may not have really eaten that day either. If she did eat, it was a very small amount.” She also had diarrhea.

Thursday morning, thinking she had the flu; Julia stayed home from work, another unusual thing for her. Later that morning she called Eric, asking him to take her to an Urgent Care. She was feeling worse. She couldn’t breathe, felt very weak and faint. Eric rushed home and took her to Urgent Care.

At Urgent Care they saw she was in respiratory distress. Her blood pressure was low and her heart was racing. As they were preparing to intubate her, she fainted. They completed the procedure and transported her to the Emergency Room. We read later in her medical records that she told them she felt “a sense of impending doom,” and we also read that the ER doctor removed a NuvaRing.

Eric called again much later that Thursday night to tell us the doctors wanted to put Julia in the ICU and asked him if her parents knew. He also told us that the doctor said her kidneys weren’t functioning and they wanted to put her on dialysis. This was more than a standard emergency room visit. The ICU? Kidneys not functioning? Dialysis? Do her parents know? We didn’t know what to think. Alarmed, worried, and not understanding what was happening, my husband and I flew the 450 miles to be with Julia.

We arrived at the hospital on Friday morning, and saw Julia briefly. She was sedated, so she didn’t know we were there. The nurse sent us to the waiting room because she needed to do some things in the room. Waiting seemed to take forever.

Sepsis or Missed Pulmonary Emboli?

An hour later the ICU doctor came to tell us that they thought Julia had septic shock and they had put her on a sepsis protocol, giving her antibiotics and antifungals to treat any infection. They also had her on vasopressors to help increase her blood pressure. They were also trying to get a dialysis machine set up.

The ICU doctor assured us that Julia would recover, saying, “Julia is young and strong.” The doctor seemed very confident as she explained that Julia would be in the ICU for a few days and moved to another floor to recover for a week or more. The doctor sounded so sure of herself.  We were still anxious and just wanted to be with our daughter. Her dad and I again were allowed to see Julia briefly although we were told again that we needed to wait in the waiting room as they were setting up equipment. We waited with Eric, his parents and sister. We cancelled the cruise trip, thinking it was just a postponement until Julia got better.

An hour later, a nurse ran into the waiting room, yelling, “West family, we need you NOW!” and rushed us down the hall to Julia’s room. The ICU team was frantically doing CPR on Julia. Shocked, we huddled together in the doorway, clutching each other, as we watched the medical team frantically work on Julia.

The ICU team stabilized Julia and we all breathed a sigh of relief and moved out into the hall. Calm was restored to the room and the staff began drifting off to other tasks. Julia went into cardiac arrest again. Again we watched the team rush to perform CPR. We stood outside a set of large sliding glass doors to Julia’s room, with disbelief and increasing dread until Julia’s heart was again stabilized. Calm lasted for what seemed like minutes. Again and again Julia went into cardiac arrest, one after another for over four hours. The ICU team kept up their heroic lifesaving efforts to resuscitate and stabilize her.

One of the doctors on the team told us that we’d have to make a decision at the end of the next hour as to whether to continue resuscitation. We’d been in the hallway for hours and we were told that Julia’s chance of being severely brain damaged was 95% because her blood was so very thin and she’d had so little oxygen to her brain. At the end of that last hour, we reluctantly and painfully told them to stop. We felt we had no option but to let her go. We believe Julia wouldn’t have wanted to live a diminished life, even if they could have saved her. The staff stopped their efforts and left the room for us to gather around Julia’s bed. Within ten minutes of stopping CPR, she was gone.

Asking Why

We left the hospital profoundly shattered and in shock. We had been told that she had septic shock, but we couldn’t understand how that led to her death. We wanted to know what had happened to our wonderful daughter. We requested an autopsy, as did the hospital. We also ordered Julia’s hospital records.

Later, my husband and I flew home. Julia’s husband, her sisters and brother were as devastated as we were.

The autopsy report stated that Julia died from massive bilateral pulmonary embolisms. The autopsy also showed she had a deep vein thrombosis (DVT) in her left leg. The blood clots in her lungs were so massive that no amount of resuscitation could have brought her back due to the massive clots blocking her lungs.

None of this made sense to us. Only the month previous, Julia had a health check up through her employer that showed she was healthy. Her blood pressure was normal, as was her cholesterol.

We wanted to know why our daughter developed pulmonary embolisms and a DVT.  We discovered Julia was using the NuvaRing. We didn’t even know what a NuvaRing was. Our youngest daughter told us that she’d heard of women getting blood clots while on NuvaRing, so we began reading about the increased risk of blood clots for women on estrogen based birth control.

The ICU doctor told us that Julia had septic shock. We knew nothing about sepsis or septic shock. We wanted answers to everything, so we contacted the ICU doctor who had treated Julia and began asking questions, lots of them.

NuvaRing Induced Disseminated Intravascular Coagulation

We learned that Julia had been treated for a condition called Disseminated Intravascular Coagulation (DIC), a process characterized by the widespread activation of the blood-clotting cascade. We had to educate ourselves about DIC and found that DIC is caused by an underlying condition. The increased clotting in DIC uses up platelets and clotting factors in the blood. DIC can cause very small clots to form throughout the body’s small blood vessels. These small blood clots can reduce or block blood flow through the blood vessels, which can damage the body’s organs.  When platelets are used up, the body isn’t able to stop bleeding, as the blood is thin due to lack of platelets. Had tiny clots formed in the small blood vessels in Julia’s body? Was this why Julia’s kidneys stopped working efficiently?

In reviewing the hospital records, we noticed that the hospital had done a CT scan of her abdomen, but they only did x-rays of her chest. We learned that clots do not show up on x-ray. A chest x-ray can find other diseases, such as pneumonia or fluid in the lungs but not blood clots.

The hospital had not done an ultrasound on Julia’s legs to look for a DVT, but leg pain or soreness was not one of Julia’s symptoms. We also looked for lab results for infection that might have caused sepsis or septic shock, but the lab records didn’t show any positive results for anything they tested for.

Julia had not complained of all the typical symptoms that you read about for a DVT or a pulmonary embolism.  We learned that many people do not have the classic symptoms.

At that first phone call with the ICU doctor, after she reviewed the autopsy report, she told us they had not known Julia had pulmonary embolisms when she went into cardiac arrest.

NuvaRing and Julia’s Death

We asked the ICU doctor if the NuvaRing had anything to do with the pulmonary embolism. This doctor, who worked so hard to save Julia, was not familiar with the NuvaRing birth control and suggested we go to the company website for information. Her suggestion made me realize that she really didn’t know much at all about the NuvaRing. She told us that none of the lab tests had shown a cause for the sepsis. She also told us that the hospital would do a formal review of Julia’s case with a team of doctors, including those who had worked on Julia. The doctor couldn’t say more until after the formal review.

The hospital team eventually reviewed everything that happened to Julia, from her admission, treatment, and to her death. We spoke to the ICU doctor again after the review, and she told us she “did a lot of reading, a lot of research on the NuvaRing and strongly felt it had been a component in Julia developing such a massive pulmonary embolism.” She also explained that “a pulmonary embolism might have been brewing,” but that because Julia’s blood developed DIC her blood had become so thin that trying to surgically treat a pulmonary embolism would have caused her to bleed to death, and they couldn’t even give her anticoagulation treatment for the clot.

More importantly as to the cause of death, the ICU doctor told us,

We do not see someone as young and healthy as Julia develop such massive pulmonary embolisms unless there is an underlying factor… and that is hormonal birth control.

The ICU doctor said she and other doctors on the team,

Personally believe the NuvaRing caused Julia’s blood to clot and develop DIC as quickly and as much as it did.

This doctor went on to say:

In young patients like her, any time we see someone pass away from a massive PE like she did, it has never been just from an infection, never been just from sepsis.

It’s always been because of some underlying pathology that has caused the blood to clot the way that it does. Usually it’s an oral contraceptive pill, that’s 90% of the time, and 10% of the time it’s because there’s a genetic predisposition that went undetected or no one in the family had had that problem before. And we didn’t find out until much later.

Julia had been using NuvaRing for two years.

We believe the hospital staff did everything they knew how to do at the time. We truly thank them for all their efforts. But we also believe that they did not connect the dots about a pulmonary embolism forming or that hormonal birth control was causing the clotting that led to Julia’s death.

Our family will never be the same. Julia, our cherished daughter, sister and wife, was young, healthy, loving, vibrant and bright. She had a whole lifetime ahead of her. Julia had confidently used NuvaRing, a combination hormonal birth control, because it had been prescribed confidently to her. We share Julia’s story with our deepest hope that this won’t ever happen to any woman you love.

Dru and Joe West

Laura West, Marc Fish, Nancy Martin and Eric Ross

Photo: Julia pictured with her dad on the day of her wedding. 

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.

Fatal Blood Clot Precipitated by the NuvaRing

3106 views

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.

Deadly Blood Clots from the NuvaRing: Erika’s Legacy

5332 views

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.

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

4705 views

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.

Blood Clots while on Hormonal Contraceptives: Fact or Fear Mongering?

5206 views

A few weeks ago, someone posted a news article on Facebook about another young woman who almost died from her hormonal birth control. One Facebook commenter made a remark that she hated the fear mongering that goes on about hormonal birth control in the news. I, on the other hand, truthfully wish more women knew what to fear. My 29-year-old daughter Julia died in 2013 from massive bi-lateral pulmonary embolisms while using NuvaRing as her birth control. We had just celebrated her marriage to a wonderful young man. Julia had been married exactly five weeks on the day she died. I cannot even begin to describe the grief we feel about her death to this day.

That Facebook comment made me think about what I now see as the fear mongering that the medical community engages in when they insist that the risk of blood clots during pregnancy and postpartum (after delivery) must always be mentioned to put the risk of blood clots “in perspective.” I began to wonder if we really know enough about the risks of blood clots with hormonal contraceptives.

Beyond Fearmongering: Learning from the Families who Lost Loved Ones to Hormonal Contraceptives

My daughter’s death led me to meet Joe Malone whose 23-year-old daughter Brittany died in 2012, also while using NuvaRing. Our daughters’ deaths have taken us on a long and frustrating journey to learn more about combination hormonal contraception (CHCs) and why our daughters died.

Joe and I understand why the medical community wants to make sure that women use some form of birth control. Maternal mortality is very high, especially in third-world countries. There are many health complications and dangers for women during pregnancy and in the weeks after delivery from a variety of causes. The risk of a blood clot is high. However, we now see how the information given about the risks for blood clots during pregnancy and postpartum is presented in such a way that seems intent on scaring women into taking hormonal contraceptives. There is little discussion about safety between the various types of hormonal birth control (pill, patch, ring, IUD or shot), or other options, such as a copper IUD or other non-hormonal methods. Every hormonal contraceptive and every formulation is pronounced safe and the risk of a serious event is declared rare.

Women are told to talk with their healthcare provider about these risks to learn more. We have found that this suggestion is insufficient because many of these providers themselves, do not understand the different risks associated with each contraceptive formulation/brand.

Inevitably, accompanying any mention of risk from a hormonal contraceptive is the stark warning that the danger of a venous thromboembolism (VTE) – a blood clot in leg or lung) is higher while pregnant or postpartum. We have learned the hard way that the risk of a blood clot may be higher, but the possibility of death from a PE while using combined hormonal contraception is even greater.

Risk for Blood Clots with Hormonal Contraceptives versus Pregnancy or Postpartum

After careful review of data from various governmental and independent agencies (see below for discussion), we now believe that the overemphasis on the risk of VTE in pregnancy creates a false sense of security regarding the safety of combined hormonal contraceptives compared to pregnancy. It minimizes the reality that something very dangerous can happen to a small, but recognizable, percentage of women who use hormonal contraceptives. Women are led to believe that hormonal contraceptives are much safer than being pregnant due to the VTE risk in pregnancy. Women are not instructed on how to recognize the early warning signs of a dangerous and potentially deadly blood clot, and sadly, we also discovered that neither are their doctors. According to data from the CDC,

more U.S. women died from pulmonary embolisms while using a combination hormonal birth control than from pulmonary embolisms while pregnant or postpartum in 2011.

There were approximately 69 deaths in the U.S. from pulmonary embolisms during pregnancy and post-partum in 2011 (the latest date for which these numbers are available), compared with approximately 307 deaths due to pulmonary embolisms for women who used a combined hormonal contraceptive pill, patch or ring in 2013 in a recent analysis Joe and I completed. A full analysis is posted on BirthControlSafety.org.

We believe the reason there are fewer deaths from a pulmonary embolism during pregnancy is that most women who are pregnant or have recently given birth are monitored much more carefully than women who use hormonal contraceptives. A woman who utilizes birth control pills, patches or a ring is seen only annually by her physician and very rarely advised of the signs and symptoms of blood clots.

When signs of potential blood clots emerge, such as chest pain, difficulty breathing or leg pain, women are told that they have bronchitis, pneumonia, asthma or a pulled muscle. You can read first-hand accounts from both men and women on a site called stoptheclot.org. When you read these stories, you hear how the medical community has a very difficult time diagnosing deep vein thrombosis or pulmonary emboli. People who go to their doctor with the symptoms of a blood clot in their lungs or leg, are more likely than not, told to take an antibiotic, a pain reliever or muscle relaxant and come back later. For many, later is often too late.

Women Who Die from Contraceptive Induced Blood Clots

Our review of the data suggest more U.S. women die from VTEs while using a combined hormonal contraceptive than during pregnancy or postpartum. This is in contrast to what is commonly reported.

Tragically, a significant number of women do die during pregnancy and the postpartum period, but they die from a variety of reasons that have nothing to do with a pulmonary embolism. You can read the list of other reasons that women die while pregnant or postpartum in the list from the CDC website. Some of the reasons for these deaths are preeclampsia, hemorrhage, and complications of caesarean section: many conditions that only occur during pregnancy or postpartum.

A 2015 study by Vinogradova, Coupland, and Hippisley-Cox published in the British Medical Journal on the use of combined oral contraceptives and risk of venous thromboembolism [8] put the risk at an even higher rate than the rates we used from the European Medicines Agency (EMA). So it is likely that we underestimated death rates associated with contraceptive induced blood clots.

Next time you read the disclaimer that “Pregnancy and the postpartum period puts a woman at higher risk for a VTE” maybe you’ll remember that this claim may not be entirely true. From what we can tell, more women die of a pulmonary embolism while using combination hormonal birth control than while pregnant or in the postpartum. Hopefully, women will become better educated to take care of their health issues before, during, and after pregnancy. In the meantime we need to educate every woman about what combined hormonal contraceptives do to a woman’s body.

Calculating the Risk for Death by Venous Thromboembolism

The CDC monitors Maternal Mortality and publishes figures on their website. For all deaths reported in 2011, “702 were found to be pregnancy-related.” This total includes deaths that occurred for a full year after childbirth [1] they also report that 9.8% of maternal deaths during pregnancy and postpartum are attributed to thrombotic pulmonary embolism. We calculated that a 9.8% rate equaled 69 deaths in 2011. At present, there are no published mortality figures from the CDC for 2013.

It is difficult to find the number of women who die from a blood clot in their lungs while using a hormonal contraceptive. The FDA’s Adverse Event database is voluntary, inconsistent and difficult to interpret. Some columns, such as the Outcome column are left blank. Even the FDA has acknowledged in the past that only 10 to 15% of adverse events are reported [2]. The FDA requires that pharmaceutical companies report adverse events, but no one else is required to report to the FDA or even to the pharmaceutical companies. Many healthcare professionals do not bother to report to the FDA, and it is unknown if they report anything to the pharmaceutical companies.

To try to understand the number of deaths caused by blood clots in the lungs, we relied on the VTE rates that the European Medicines Agency (EMA) publishes. In 2014, the EMA circulated a table of VTE rates [3].  This table gives a range for each type of progestin hormone involved in each of the combined hormonal contraceptives.

In the U.S., the FDA allows companies to put a chart on the package inserts listing estimates of venous thromboembolism which are currently estimated at 3-12 events per 10,000 women, but that number is lumped together for all formulations of hormonal contraceptives. By combining the rate of blood clot for each of the different types of hormonal contraceptive, it is impossible to look more deeply at the figures, especially at which hormones might be causing more blood clots. The EMA information allows this type of review.

We also purchased the prescription data from IMS Health and used information from the CDC to determine the number of women in 2013 that used different combination hormonal birth control products. IMS Health is a leading global information and technology services company, providing prescription drug data to a variety of corporations, and groups, including the FDA. The EMA gives a range of VTE rates based on the type of progestin hormone used, illustrated in Table 1.

Table 1: EMA Risk of Developing a Blood Clot.

Table 1- EMA Risk of developing a blood clot (VTE) in a yearBecause the number of deaths while using a combined hormonal contraceptive is unknown, we decided to calculate how many women might die. We used information from the reference book Contraception Technology [3], which says that 66% of women with a VTE will have a deep vein thrombosis and 33% with a VTE will have a pulmonary embolism. They cited a death rate of 6% for women with a DVT, and a death rate of 12% for women with a pulmonary embolism.

Using the data for contraceptive methods published in 2013, which is very similar to the CDC’s 2011 data, we calculated that there were approximately 11,000,000 women using a hormonal contraceptive that contained an estrogen and a progestin. The basic information is shown in Table 2.

Table 2: Comparing VTE Impact (estimated) across 2nd – 4th Generation Combination Hormonal Contraceptives for U.S. Women in 2013.

Table 2 Data Points

Next we calculated the estimated number of women potentially affected with a VTE, DVT, or PE using both the low and high EMA rates. We then calculated an average of these numbers. The estimated average number of deaths in 2013 from a pulmonary embolism is 307 deaths. This does not include deaths from a deep vein thrombosis, stroke, cerebrovascular accident, or hemorrhage or any other cause triggered by a combined hormonal contraceptive. Table 1 looks at the estimated rate of VTEs for different generations of contraceptives while Table 3, shows our calculations for VTEs, DVTs or PEs events [5].

Table 3: Calculations for VTEs based on type of progestin.

Table 3- Comparing Annual VTE rate

Joe Malone recently calculated the number of deaths in another way. He took the number of U.S. births in 2013, published by the National Center for Health Statistics[6], and numbers from a study by A.H. James [7] who stated that “VTE accounts for 1.1 deaths per 100,000 deliveries, or 10% of all maternal deaths.”

Using information from James’ study, Joe calculated that approximately 43 women died because of a VTE in 2013. (See Table 4). This number is far lower than the 307 women we calculated to have died in our analysis of women on combined hormonal contraceptives. The lower number of deaths in James’ study may be due to several factors. For example, James’ study was of deliveries, not pregnancies. The number of deliveries likely is lower than the number of women who become pregnant. Another factor might be that the number of deaths reported on the CDC website of pregnant women includes women who died up to one full year after giving birth, which would result in higher totals.

Table 4: Comparison of VTE Related Deaths – Pregnancy & CHC Use

Table 4 Pregnancy & CHC deathsBy whatever numbers we used, however, the death rate attributed to blood clots was higher in women using hormonal contraceptives than in pregnancy or postpartum. Moreover, the death rate was significantly higher. By continuing to suggest that the risk for blood clots, and indeed, death as a result of those blood clots, is higher in pregnant and postpartum women than in women using hormonal contraceptives, we place the health and well-being of millions of women in danger; and for some, this risk is deadly.

When I think about the fear mongering comment made in regards to an article about hormonal contraceptive safety, I cannot help but wonder if more information were made available, fewer families would experience the loss of a daughter, wife or mother. Understanding the real risks associated with a medication shouldn’t be considered fearmongering, just the opposite. In fact, to elevate the risk of death due to blood clots in pregnancy or postpartum above those of the medication, is not only fear mongering but dangerous.

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.

References and Resources

  1. Pregnancy Mortality Surveillance System, Centers for Disease Control and Prevention, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion. Updated December 23, 2014. http://www.cdc.gov/reproductivehealth/MaternalInfantHealth/PMSS.html/.
  2. Hazell, L. & Shakir, S. A. W. Under-Reporting of Adverse Drug Reactions A Systematic Review. Drug Safety 2006; 29 (5): (pp. 385-396). Retrieved from https://www.eecs.berkeley.edu/~daw/teaching/c79- s13/readings/AdverseDrugReactions.pdf
  3. European Medicines Agency. (2013). Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation,. Press Release dated 11/22/2013. Retrieved from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 13/11/ news_detail_001969.jsp&mid=WC0b01ac058004d5c1
  4. A. L. Nelson, M.D. & C. Cwiak, M.D., MPH, (2011). Combined Oral Contraceptives (COCs). In Hatcher, R. D., MD, Trussell, J., PhD., Nelson, A. L., M.D., Cates Jr., W., M.D., MPH, Kowal D., M.A., P.A., Policar, & M. S., MD, MPH. Contraception Technology (20th Edition). Chapter 11, (pp.249-275). Bridging the Gap Communications.
  5. Malone, J., West, D. & West, J. (2015) Retrieved from www.birthcontrolsafety.org, http://www.birthcontrolsafety.org/data–references.html and www.Nuvaringtruth.com, http://nuvaringtruth.com/women-injured-or-died-from-combination-hormonal-birth-control-in-2013/
  6. NCH Data Briefs, Number 175, December 2014. Births in the United States, 2013. Retrieved from http://www.cdc.gov/nchs/data/databriefs/db175.pdf
  7. James, A. H. (2009). Venous thromboembolism in pregnancy. Arteriosclerosis, thrombosis,and vascular biology, 29(3), 326-331. Retrieved from http://atvb.ahajournals.org/content/29/3/326.full
  8. Vinogradova Yana, Coupland Carol, Hippisley-Cox Julia. Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases BMJ 2015; 350: h2135. Retrieved from http://www.bmj.com/content/350/bmj.h2135