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J&J Has Paid Over $68.7 Million In Ortho Evra Lawsuits

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Johnson & Johnson has paid out over $68.7 million in private settlements in Ortho Evra birth-control related claims. The Public Citizen’s Health Research Group is petitioning the FDA to take it off the market. The most common complaints among users of the contraceptive patch that adheres to the skin are blood clots in the legs, blood clots in the lungs, and hearts attacks/strokes. But hey, at least you don't have a baby. [Bloomberg]

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I thought that was a joke headline at first.

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Wow, over $68 in lawsuits! How do they stay in business?

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Yeah...set an alert on your phone or something. Patches are not worth the increased risk. 60 percent more estrogen?! What part of that sounds reasonable or worth the risk?

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haven't they been petitioning the FDA about this for years? it was 2006 when my insurance company stopped covering this stuff.

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@IHaveAFreezeRay: Oops. the "set an alert on your phone" was a response to the information in the article that said the ortho evra patch was developed for women who were afraid they would forget to take a pill every day.

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Errr.. I'm on the patch and my doctor told me that the amount of Estrogen wasn't any more than in other types of birth control. And I LOVE it. I would be very sad if they took it off the market.

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@LindsayC: Me too,never had a problem. Even have 'better' periods with it.

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These patches are NO JOKE. Sucking up that much hormone directly through the skin is not a good idea. You can trust me on that.

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I knew this patch was sketchy when it first came out. And I don't understand what's so hard about remembering to take a pill everyday. I've been on the pill since I was a teenager and I love it. Just take it at the same time everyday and you stay baby-free!

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About three years ago, my ob/gyn said that the patch presented too many problems -- blood clots, etc -- and that she wasn't comfortable prescribing it for me. She hasn't prescribed since then.

Kind of sucks for me, because I have a REALLY hard time swallowing and keeping down pills. Yes, even if they're itty-bitty. Yes, even if I try crushing them. The patch was an absolutely awesome solution for me... well, until the problems. I really hope they get things straightened out. :(

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@u2acro: Also, that patch was sticky as hell. I usually ripped off skin as I removed it. I'd go around with a little red square for days. That's why they told you to alternate where you put it. :(

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@LindsayC: The article did mention that J&J changed their labels to include a stronger warning...I think a lot of doctors get their information from the information given to them by the FDA, which gets their info from J&J, and you know how that goes. My doc mentioned the patch as an option as well, and didn't mention the increased warnings. I found out about that on my own, though I didn't know (til now) how much of an increase in estrogen there was.

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@LindsayC: This is probably a stupid question...are you on this same patch? Cause there's also the other patch, the name escapes me right now...but I haven't heard about increased risk for that one.

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Try Nuva Ring - same as the pill, no swallowing!

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@u2acro: Drink a whole glass of water with it. I don't usually have a problem swallowing medication, but sometimes the act of swallowing doesn't catch small pills, and it's hard to move it toward your throat. Water creates motion that will help you swallow it easier.

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@IHaveAFreezeRay: Nope it's Ortho Evra. My doctor did tell me that there was more Estrogen than in a regular pill. We talked about it though and he doesn't feel that I'm at risk (non-smoker, under 35, no family history etc etc.).

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@womynist: I hated the pill because I was paranoid every month that I was going to get knocked up because I took it at 6:30 one day and 7:00 the next and oh SHIT I forgot on Saturday and didn't take it until 9:00. I needed an option with less chance of human error. So I didn't end up with a squidgy little human error of my very own.

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@IHaveAFreezeRay:
Seriously, anyone who has problems taking pills has heard AL of the little tricks to taking them and they don't work. Really, we've tried them all.

On the subject of the patch, I loved it while I was on it but started having issues with it scooting over form where I put it, decreasing the adhesive left on the patch until I'd get corners lifting. I switched to the ring shortly after since I was changing the patch more often than I should have to and it was costing too much.

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@LindsayC: I freaked out about that too, but I talked to my doc and she was like "as long as you don't STOP taking it, a variation in half an hour is not a problem." So I don't worry about it anymore. I generally do take them at around the same time every day, but it's not like life and death.

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Perfect for all those women who don't want to be punished with a baby.

/end Obamamode

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@LindsayC: There may not be an increased amount of estrogen in the product, but the AUC levels are higher in this transdermal patch than with oral contraceptives. The AUC denotes basically how much of the drug is in your system over time. It is higher because absorbing the drug transdermally would bypass your 1st pass metabolism in your liver which leads to the drug not being broken down before going through your system. This is possibly the reason why people are getting blood clots. Ortha Evra is dangerous in my opinion and should be removed from the market, especially when there are many other options as to birth control. No need to put the public at risk when so many other options are available such as condoms, nuva ring, oral contraceptives, intrauterine devices, sponges, and injections just to name a few.

-Phex
-3rd Year PharmD / MBA Candidate

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i used to be on orthoevra, i went to class one day and couldn't see out of my right eye, and the whole right side of my body was numb, and i had the worst headache ive ever had in my entire life. naturally, i had to leave class....i went outside, sat on a bench, and tore that patch off. i mentioned it to my doctor (i am now on nuvaring) but apparently no one is worried that i had a stroke......

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I never had a problem with Ortho-Evra until I lost 30lbs. Then the shit hit the fan and side effects started to emerge. My biggest complaint was the itching and big red squares I had to weather.

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Yeah, I got a clot on OrthoEvra. It was in my arm and I am now totally fine, but needless to say at that point I ran far far away and was not surprised when the news of the deaths came out. Nuvaring is awesome, although now I have a copper IUD which is the best form of birth control ever. Seriously.

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@u2acro: I'm doing the nicotine patch and it does make the spot red. That's the nature of glue + body.

Why don't you try some of the alternatives mentioned, such as the nuvaring? My friend's wife uses that and they're both very pleased with it.

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@Ein2015: I know birth control is a very personal decision, but FYI: my 25 year old sister is currently in the hospital recovering after spending an extremely scary 5 days in ICU for blood clots in her lungs and legs from the nuvaring. Just thought I'd pass it on that the ring has some of the same risks.

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@BrawlerBarbie: I was wondering whether the side effects were more apparent depending on your size. My doc didn't say anything about ortho evra, but did say that I needed the lowest dosage of whatever I choose because of my size (5'3).

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@IHaveAFreezeRay: Not to say you're huge or anything, but I meant to imply that people who are taller than average may need a higher dose or people who lose weight would need to switch doses, but doctors don't tell you that.

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All forms of birth control hormones have those risks. This one maybe a bit more. However, it says those risks right on the label.

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I was put on Ortho Evra at 14 to treat hormone-related migraines. My neurologist reasoned (correctly) that all the extra hormones would kick the migraines. No migraine meds, unconventional methods, or other birth controls helped. Ortho Evra really saved me and let me go through high school like a normal kid.

I quit using it at 19 after I grew out of the headaches and after a few years of really bad side effects. I'm 20 now and it wasn't until a few months ago that my hormones got straightened out after 5 years of Ortho Evra. I can no longer take any hormone-based birth control without my body tweaking out. Also, I am now on militant breast cancer watch after a scare a few months ago. I blame both on the Ortho Evra.

So yeah, that's my Ortho Evra story. It's pretty evil, but I can't hate on it too much.

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@IHaveAFreezeRay: I think the size of women taking the medication is an issue -- I've heard for years that the pill is less effective for women over 200 pounds, and I suspect it's a dosage problem. I find it odd that I am 5'10" and 175, yet on the exact same BC as my 5'3", 110-pound friend. I wonder if she's getting too much of the hormones?

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@unpolloloco: The thing is, J&J outright LIED and, initially, claimed that the patch had a lower dose of hormones than the pill, EVEN WHEN THEY KNEW THAT WAS UNTRUE.

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@IHaveAFreezeRay: The information that comes with the patches states a weight limit of about 198lbs. I had no issues at 210lbs (no babies either). It was when I hit 180 that I started spotting, getting moody, and experiencing random pain.

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@LindsayC: Doctors are not gods. They don't know everything and are, *gasp* often wrong about stuff. I was just told about how a doc recommended something to a patient and the patient said no I don't want to worry about . Doc tried to tell them that wasn't a side effect and the patient had to make the doctor get the package and actually READ the package insert to prove that is was indeed a side effect. I never *blindly* trust what a doctor tells me - I do research of my own to make sure they aren't feeding me crap. After all...some docs tell us things based on something that was believed to be true 10 years ago when they started practicing, some docs tell us stuff based on the fact that the pharma companies shower them with gifts, and some docs tell us stuff based on nothing but their own opinion.

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@domesticdork: sorry...part of the sentence vanished...supposed to read:

"and the patient said "No, I don't want to worry about -insert side effect here-"

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The packaging for the Nuva ring says 8 out of 10 men and women can't feel the ring during sex, and the other 2 don't mind. Either they need to check their numbers or my wife and I are the extremely small statistical minority, because it was highly uncomfortable for my wife... I didn't care much for it, either.

The list of available contraceptives keeps getting shorter. Condoms are always available, but we don't like to rely on one method. The patch is out due to health risks, Ortho Tri-Cyclen and Ortho Low absolutely kill my wife's libido, and she doesn't want anything as long term as an IUD or injection.

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these are all standard risks for hormonal birth control. as nice it as it is to have that higher effective rate, you shouldn't fuck with mother nature too much or she kicks you in the face. use condoms. they have a higher rate of effectiveness in the average user than any hormonal birth control anyway.

@Jetgirly: also considering the patch is on for seven days i'd assume the dosage would be higher in the first half of that week than the second simply due to the mechanics of the dosing system. it's not something time released over a 24 hour day or digested through an internal organ it just leaks directly into your skin. so that means an entire seven day dose is sitting right on you all at once and depending on how fast you personally absorb it that would alter your risk. maybe the hormonal dose IS lower on average over that 7 day period but because of how it's administered it's a lot higher after the initial application of the patch.

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@womynist: I went on the patch because I had gallstones - the pill is processed through the liver and can cause (more) gallstones, whereas the patch isn't processed through the liver. In addition, even though I took the pill at the exact same minute every day, I had spotting all the time.

I was on the patch for three years, I think? Between three and four. No real problems, until towards the end, when I started experiencing a reduced sex drive, which was no fun.

I seem to need slightly higher estrogen levels, though - the one time I was on a low estrogen pill, I got my period every two weeks, and became anemic in the six weeks I was on it.

There probably should have been more care taken in the indiscriminate prescribing of Ortho-Evra, since I don't think there's quite enough understanding of transdermal delivery as there should be. On the other hand, I was very grateful for it.

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And here I was, thinking that those "Call us to sue if you used Ortho Evra patches!" commercials were a scam.

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I would be very sad if they took this off the market, as it has been my method of choice for almost seven years. In addition to the obvious benefit of only worrying about it once per week, I have had no side effects and I'm not pregnant yet.

While it may contribute to blood clots, I am a healthy young woman with no other risk factors, and thus have made the decision, along with my doctor, to accept that risk.

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My girlfriend just got NuvaRing recently, and that's worked great. It's sort of like the patch insofar as there's no pill to remember (which was hard for her because she had such a varied schedule), and it only had to be replaced once a month.


Plus, you don't feel it at all during sex, which was a worry for both of us.


So yeah, I'd definitely consider the ring over the patch.

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@AuntieMaim: Well, the same kind of birth control can have multiple levels of dosage. I'm on the lowest dosage of my kind because of my size and because I don't have any other medical issues. Overall, I'm pretty run of the mill. Someone who is taller or bigger in general (I, like your friend, am 5'3 and 110 lbs) might not need a higher dosage unless she were much bigger, say over 200 pounds or were 6'1.

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@unpolloloco: And that's the thing to remember with all forms of medical control. They all have the risks, and they generally all have the same risks. So does hormone replacement therapy for women in menopause. They all carry the same risks, it's just that some people are more susceptible to developing the clots and conditions, and doctors need to acknowledge that the pills might be more or less similar, but women aren't, and there needs to be more discussion between doctors and their patients so they can reasonably tell their patients the best course of action, especially if their patient has a medical history which may pose a problem if X medical control is used versus Y medical control, or neither.

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@FatLynn: My biggest hangup is that I don't know what aids in these risk factors. My family doesn't have a history of heart problems or cancer or anything, but what does that mean to me in regards of choosing a medication? I don't know. I think the problem is lack of attention in the medical community to educate.

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@IHaveAFreezeRay: Family history, inactivity, smoking, age, obesity

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href="#c8527776">womynist: @LindsayC: Many women can't handle the hormone "rush" you get when you take the pill and become nauseous after they take it -- thereby running the risk of throwing the thing up every day. And throwing up something that's administered orally basically defeats the entire purpose.

On a related note, I was on the patch for about a year and I despised everything about it. Weight gain, becoming emotionally unhinged, loosing all interest in sex to begin with (which I suppose makes it all that more effective,) not to mention that the damn thing kept coming off and attaching itself to my clothes.

Bleh. I had an infinitely better experience with the ring, which I was switched to basically the instant it was approved.

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When my OB/Gyn suggested I go on the pill, I asked her if it was safe. She said, "A heck of a lot safer than being pregnant, that's for sure!"

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@FatLynn: I have used this for 3-4 years and I have had no problems either ^^

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@ohenry: I too am on the NuvaRing now, and I love it. I was on the patch for about 3 years, and I never had any health-related problems with it at all (blood clots, weight gain, etc). However, after finding out the risks, I'm glad I switched. I do think there need to be options other than taking a pill every day for women - I couldn't take a pill every day to save my life. But I can't imagine why a woman couldn't switch from the patch to NuvaRing.

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@nicemarmot617: I wish. The copper IUD didn't last me but 8 months - my body apparently rejected it, pushed it out and it got stuck coming out. Not fun getting that removed, 20 times worse than putting it in. They won't give me another one.


Next step: STERILIZATION. Birth control hates me.