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Blood Clots No Joke For Wearers of Ortho Evra Contraceptive Patch
41 Comments | Posted by Sarah in Adrianna Niedner, FDA, Ortho Evra
Adrianna Niedner, former A student of Concord Academy, involved in sports, and freshman at Trinity College, had the world at her feet. She had a mother whom she adored and had mutual regard, had lived a full seventeen years and had only begun her life.
Adrianna Niedner passed away this past September due to a pulmonary embolism, which is a blood clot in the lung. She was seventeen years old and had just begun her first step toward responsibility; she got on birth control Ortho Evra, birth control method known as the “patch”.
Upon discovering her daughter’s demise, Leslie Niedner began investigating the reason as to why a woman so young in age and so healthy would have succumbed to such a strange death. Leslie began research as to the negative effect on women who use the Ortho Evra patch upon suggestion by a friend. She was astounded to find that her daughter was not the only one who allegedly died from a fatal pulmonary embolism, possibly brought on as a side-effect to the patch.
With more research, she uncovered the fact that the Food and Drug Administration had released a statement in 2005 regarding the issue that this type of contraceptive subjected the wearer to 60% more estrogen than those women who utilized oral contraceptives. Long have scientists known that overexposure to estrogen can sometimes lead to a heightened risk of blood clots, strokes and heart attacks. That was the year that the FDA had received over twenty-one reports of fatal or near-fatal incidents involving blood clots suffered by the patient.
This prompted the FDA to further investigate the adverse effects of the Ortho Evra patch on the women who wore them. In 2006, a study determined that wearers of the patch were twice as likely to suffer a clot injury than women who took oral contraceptives. At this point, Johnson & Johnson, creators of the Ortho Evra patch, were made to issue a statement regarding the severity of possible issues that could arise by using the patch.
Leslie Niedner, a now-childless woman, is lamenting the loss of a young woman who need not be dead. Whether it’s the FDAs fault for not banning what appears to be a dangerous drug or Johnson & Johnson’s issue by not reformatting the drug and making necessary changes to lower the negative statistics, will remain to be seen.
However, with lawsuits adding up to the almost-billions, it’s hard to accept the fact that this young woman is forever lost because of negligence, once again, in the medical field.
I didn’t know the patch was still around, haven’t known anyone on it since about 2006 when I first started hearing horror stories of death and destruction from it.
Unfortunately I’ve really struggled with birth control pills as I seem to get used to them somehow and start ovulating again, causing giant painful cysts on my right ovary that they have to surgically remove for fear of them twisting and killing my ovary. But glad I never switched to the patch.
Hormonal birth control in general has so many issues and causes so many lasting health effects. I don’t know why so many people consider it to be a good thing for women.
I was on hormonal birth control not to prevent pregnancy but to prevent the spreading of my endometriosis which was so terrible I would go to the hospital for the pain. They said the benefits outweighed the risks… guess they really didn’t in the long run (i had the strokes in the post below.)
Wow, that really sucks. Sorry you had to go through that. I hope you found another treatment for the endometriosis. I had trouble with the pill too. Until I went on the pill I didn’t have any issues but when I went off to try and get pregnant I suddenly had PCOS. Nothing else had changed really, gained a couple of pounds but just went from a 10 to a 12 so nothing significant. I haven’t used any birth control in about 6 1/2 years and I have one kid who’s 4 years old. I blame the pill.
Many people consider it a good thing for women, because it’s better than the other options. For each person who has one of these complications, many women don’t.
I find the idea of messing with hormones to be rather distasteful. I wish there were some mechanical thing, or other way to 100% prevent pregnancy, but there isn’t. To be pretty well sure, you require an invasive operation, and that doesn’t leave the option of reversability. Many couples want to have children someday, but really really don’t want them now. What are they to do, besides not have sex? (I consider that an unsatisfactory solution. Even if you were to promote it for teenagers, what about a 25-year old married couple who want to put of children until they finish their graduate degrees? I think ‘don’t have sex’ is completely insufficient.)
While I very much wish for better technology in this area, at present, hormonal birth control is the best option for many people.
I was at the doc’s the other day and we discussed the IUD. It’s more popular again because of how tricky the hormones are. It seems really simple – I never knew that it’s basically just a copper coil and sperm doesn’t like copper. The doctor inserts it and it’s good for five years.
The questions about the IUD’s ability to prevent implantation are a problem for some people. It is supposed to be spermicidal, but its incredible ability to flush out fertilised eggs as ‘emergency contraception’ suggests that it works to irritate the uterine lining. Depending on what is considered conception, this is a no-go for some women.
The IUD is also associated with heavier bleeding, and potentially painful periods. This is in stark contrast to the lessened bleeding that is one of the biggest side benefits of pills.
So it’s definitely another option, but I consider it equally unacceptable. I don’t think we currently have anything that can satisfactorily prevent conception without problematic side effects.
Kai that’s interesting, thanks for the info. I knew it sounded too good to be true. arrgh frustrating.
well, like with the pill, it doesn’t mean that it won’t work for you. Just that it fails to work for enough people to be insufficient for the complete solution I dream of.
I had the IUD for 5 yrs & I absolutely loved every minute of it. I didn’t have any side effects, I didn’t have to remember to take the pill everyday, we didn’t have to use condoms (I’m married, 9ys) And my periods were so light that I maybe used a panty liner but usually didn’t even have a period. And I didn’t have cramps ever either. When I got the last one out I would have replaced it w/ another immediately but we couldn’t afford it. But we are saving & will have enough by the 1st of the year. So for now I’m back on the pill. I know everyone is different but it was great for me & thought I’d share my experience.
I get horrible painful cysts, the females in my family get severe period pain to the point of missing work/school, off the pill if I bleed so much that I fill a heavy overnight pad plus a super tampon in half an hour.
On the pill I know when my period will be, I can barely use light tampons its so little blood, i have no cramps, I generally don’t get cysts. It is a good thing for women like myself.
Yeah, I’ve been on the patch for over a year now and the only thing that’s different is my sex drive is lower, which is actually a good thing because it now matches my fiancee’s, so he doesn’t have to try to “keep up” with me and I’m not trying to jump him all the time. -_-
My period is more predictable, my SYMPTOMS are more predictable (so I can plan to take a day off work in advance because I know within a 3-day window when I’ll need to stay home and curl up on the couch with a heating pad and pain meds), and my period has gotten a bit shorter over time. It’s great. I’m aware that there are side effects, but then again, there are possible side effects to ANYthing you ingest, so I’m not really going to spend all my time freaking out about it. So far so good (knock on wood and all that).
If i weren’t on the pill I would get a seven day period every seven days. And the bleeding was so heavy that I needed both a tampon and a pad at all times. I was getting yeast infections from constant tampon use… I hate the pill and I’ve been on several kinds, but at this point in my life it’s worth it.
I was on NuvaRing for TWO months (was not a smoker, had just turned 25, not overweight in the slightest) and suffered TWO strokes and was paralyzed on the right side of my body for over a month. Lots of medical bills and physical therapy and I’m much better, not 100 percent (still have some neuropsychological stuff going on with mmeory loss and concentration issues and mood swings) but the only thing the doctors can determine was that it was caused by the stupid birth control.
Wow, when I was 27 I had a stroke that effected the right side of my body too! It was a mystery as to why it happened because I wasn’t on any sort of hormone. I do have a defect in my heart that is often a factor in young people having strokes (do you have it? they say it’s common, just a little hole between the chambers where the wall doesn’t close up – there’s a procedure to fix it that I will get someday)
I’m so glad you are almost better! In my case I didn’t have anything to blame (just bad luck as I am quite healthy too) I would’ve been so angry if there was something directly at fault like NuvaRing! Can NuvaRing compensate you? (I know nothing can fix what happened…but..)
Best of luck to you Jen, it’s so scary isn’t it?
“…it’s hard to accept the fact that this young woman is forever lost because of negligence, once again, in the medical field.”
The implication that the medical field has repeatedly failed, and that negligence resulted in this young woman’s death, is a gross inaccuracy. I don’t believe the doctor was at fault; she probably presented the young woman with her options and/or the young woman asked to be prescribed the Patch. It’s a sad case, to be sure, and I believe this death was probably preventable and attributable to the Patch. But can we really complain when we ask for something (more convenient methods of contraception) and are faced with “trade offs” (treatment/side effects) for the sake of convenience? I’m sure the Patch appeals to many women because it is convenient, but before beginning any medication, it’s important to discuss with your doctor any possible risks involved, and doing research yourself may be beneficial. There is a great deal of literature stating the increased risk of blood clots when taking the Pill, and this risk is increased for users on the Patch. You need to weigh the potential benefits, one of which is the convenience, against the risks involved.
It is improbable that you would ever find a “perfect” drug that is 100% safe and efficacious because there are too many variables. The drug may be used imperfectly: you might take it at different times of day, miss doses, or disregard other instructions, such as forgetting to take it with food. Your lifestyle might have an impact: grapefruit, alcohol, or other drugs might interact with the medication, causing it to be absorbed differently. Your diet and exercise habits might be adversely affecting your health. People taking medication are often ailing to begin with. Genetically, people are different: individuals, or different races, may respond differently to medication. Just because a medicine is deemed “safe” does not mean it is safe for every person that takes it; it means that among the population of all potential users, the risk is acceptable for the benefit incurred. Unfortunately, many patients view an advertisement that makes the medication seem efficacious and risk-free, and then pressure their doctor into prescribing it.
It doesn’t make sense to blame science, or medical professionals, for the fact that some variables cannot be controlled. Nothing is 100% safe and 100% effective.
I agree with Anon completely.
Drugs have side effects. All of them. For any drug that has ever been taken, someone has died from it. And I am willing to bet that there are drugs available right now which have a far higher fatality rate than the Ortho Evra. Medications come with lists of potential side effects, and when you decide to take any given drug, you are accepting those side effects.
It is very sad that this young woman died, but I think claiming her death was a case of negligence is misplacing blame.
I agree, it shouldn’t be considered negligence. But it IS the fault of the medication. It’s like saying cigarette smoking didn’t cause someone’s lung cancer. Sure, the person had the option not to smoke, but they did and ultimately the negative side effect happened.
I agree, having been on the patch and also the Nuva Ring that another commenter spoke of, I was told a list of possible side effects that include all these things (stroke, heart attack, clots, etc).
There is a risk associated with almost every drug that one can take and the extreme end of the risks are usually fatal. As sad as it is that this poor young woman died from her birth control, it is a risk that was likely told to her by her doctor, and unfortunately she happened to be one of the <1% of people that suffers the most extreme of side effects.
Media likes to report on the most extreme and rare cases of things because that is what sells, be it the 0.01% of people who die from drug side effects or the 0.01% of children that are abducted while 99.99% can take the drug without side effect and make it home safe after school.
The implication is that the FDA should not have approved this drug. There is already an effective hormonal birth control product on the market.
This product doesn’t offer any increase of protection from pregnancy. The convenience of a patch over a pill is not a good enough reason to approve a drug that actually increases the risk of dangerous side effects.
Really? There would need to be balancing of how much the risk is raised and how much the convenience is increased. And how much the risk is in the first place. If it’s quite low, it could double and still be plenty acceptable.
For many people who chose this option, obviously the convenience is worth the risk. Based on the minute number of people able to take daily pills with regularity, I’d bet this is vastly more convenient for a lot of people.
And as there will always be some risk in anything, as someone mentioned above, I think it’s important to fully inform people of all the options, benefits, and risks, and then allow them to make their own decisions for their own body.
Seriously? A “minute” number of people are able to take a pill daily?
Look at the difference between the stats on ‘perfect use’ and ‘actual use’. It seems that for a lot of people it is rather difficult to remember at the same time every day. I don’t think it should be, but it does seem to be.
I looked it up. 8% of people using it incorrectly hardly constitutes a “minute” number of people using it properly.
Honestly I think it would be easier to remember to take a pill daily rather than change a patch weekly. There are things you do every day like brush your teeth, get up or go to bed, or drink your morning coffee that can serve as reminders to take your pill. There aren’t that many things that women do once a week that they can associate that with.
I know a few people who used that patch and none of them found it convenient. It seems that most women have issues with it either rubbing off or not wanting to come off at the end of the week. About half the women I know who used it had trouble with a rash. One woman got so hormonally crazy on it that she had to quit and go back to oral pills.
I just take mine every night when I brush my teeth. Considering I’m anal about brushing my teeth before I can fall asleep, it works pretty well.
When I was looking over my options, I remember seeing that the patch actually has a higher effectiveness due to its higher levels of estrogen, the same reason it has higher risks. I could be wrong – it was a while ago – but that was one of the reasons I chose it over the pill.
Most pills have a 99.9% effective rate. How does it get higher than that?
I wish the article said whether she smoked, or not.
I wish the article said whether or not the damn researchers are developing an oral/topical contraceptive for men.
He can hang his ass out to the wind and let me off the hook anytime so I can enjoy a free from fear of pregnancy sex life free from pregnancy prevention drugs, devices, etc. I’m tired of shouldering the responsibility and risk of contraception. Let him pop the pills, take the shots, wear the patch or shove it where the sun don’t shine. Of course there’s always vasectomy . . . we all know how attractive a majority of men find this an attractive alternative never mind that it precludes ease and surity of a future that inlcudes children.
But I digress. I will bet my ass that were the afore-mentioned male contraceptive made available, cooperation on his part would promote a quality of sexual reciprocity on my part guaranteed to satisfy both our parts.
That is not to say I “hold out” on him deliberately because of this specific issue. But the whole damn process does cast a pall upon my relations of the sexual variety with the opposite sex for reasons too numerous for me to elaborate given my blah blah blah thus far.
However, I must state one last thing: I am epiphanic(?) epiphonizing(?) whatever, I’ve experienced an epiphany right here, now. For all the years of my sex life I’ve been haunted by a spectre of resentment nurtured on social presumption that birth control is the “woman’s responsibility” and that damn ghost cast a pall over all my loves. The ghost in me materialized finally and after taking a good look at it I’ve finally named and claimed the little bitch. And that is a good thing my friends . . . for both of us. If you can’t see it you can’t fix it.
Damn! Thanks Zelda Lilly and the collective “voices” of “feminism in a bra.” I think I’ll have a great weekend. Same to you.
I not only followed all that, I agree that shouldering the sexual responsibility can cast a pall over sex in general.
I know for sure because after my husband got a vasectomy, sex no longer equaled stress or resentment.
His penis is no longer the enemy. It’s a very, very good friend.
haha good for you! love that.
I’ve been on birth control to clear up my endometriosis and ovarian cysts and now I feel so much better. Yay pill!
Honestly, there are just too many risks and horror stories regarding birth control for women–pill, patch, ring, IUD, you name it.
I think my fiance and I will stick to condoms.
My doctor made me get off birth control because I am diabetic. She suggested the IUD. I was apprehensive because of the horror stories I had heard in the ’70’s but she explained the new version did not have the same issues. Also women in Europe have been using it for years.
Now five years later I have to say its the best move I ever made. No worries about forgetting the pill (and on the pill my sex drive was diminished which sucked). No rushing to the bathroom to insert anything. One visit every four years too–I can’t recommend the IUD highly enough!
I used the patch a few years ago and had to go off it after a few months. I am blessed with naturally light periods with little cramping, but the patch made me gush blood and cramp so hard I couldn’t function. I replaced it with nuva-ring and have nothing but good things to say about it.
The potential side-effects of hormonal birth control are so well known that no remotely informed woman could be ignorant of them. They are j st so rare and so many people have “It would never happen to me” syndrome that we dismiss them. The fact is, that for most of us hormonal birth control is still the safest and most reliable way to take charge of our own fertility.
I think my fiance and I will stick to condoms.
Resvera-troll, kindly stop cluttering up the blog with your copy and paste antics.
Wow, I must be awesome–this is the second time He/She/It has copy-pasted my comments. Go me!
Hmm, I have to say I have had very good experiences with the patch.
I asked my doctor about blood clots and he said if I was going to clot I would have done so in my first or 2nd month of being on it, and that it was a very very small chance. Also, I’m fat and a very occasional smoker. It hasnt dampened my sex drive in the least. I will stay on it til I decide to have children, or my SO has a vasectomy.
This isnt a case of negligence in the medical field, its a case of negligence in the PHARMACEUTICAL field. This huge money hungry companies dont give a damn about who they kill/hurt. Why is the patch still on the market? Why is Yaz still on the market? An old roomate of mine was on a birth control pills, and was brought to the ER one night with THREE pulmonary embolisms! I work in the radiology field, and PE’s are something you see in older folks. And you usually only see one in them!!! I will never ever take birth control pills/patches/iuds whatever.. for the rest of my life. They screw with my body and makes me feel like crap.. And I have endometriosis, and I still wont take birth control..