The birth control patch, touted to be as safe as the pill, is actually three times more likely to cause fatal blood clots.
An investigation by the Associated Press revealed a death rate much higher than expected, about a dozen young women (most were in their late teens and early 20s) died last year from blood clots believed to be caused by the patch Ortho Evra.
Blood clots are an accepted risk from hormonal birth control because estrogen promotes blood coagulation.
The AP found that before the patch was approved, the FDA had already noticed nonfatal blood clots from the patch were three times that of the pill. The AP then examined what has actually happened since the patch came on the market and found that deaths also appear to be at least three times as high.
If you are a woman taking the pill who doesn't smoke and is under 35, the chance that you are going to have a blood clot that doesn't kill you is between 1 and 3 in 10,000. Your risk of dying from a blood clot while using the pill is about 1 in 200,000.
By contrast, with the patch, the rate of nonfatal blood clots was about 12 out of 10,000 users during the clinical trials, while the rate of deaths appears to be 3 out of 200,000.
Clots usually form in the legs, and become serious problems if they travel to a woman's heart, lungs or brain.
The AP also found 23 deaths associated with the patch and 16,000 reports of adverse reactions since the patch’s release in 2002.
Why such a big difference between the patch and the pill, both of which have similar estrogen levels? It’s most likely related to the way the patch is administered. The hormones from the pill have to go through the intestinal tract before they hit the bloodstream, hormones from the patch go directly into the bloodstream.
Some doctors the AP spoke to found the number of deaths “suspicious,” “worrisome” and “shocking.” Others (two of which used to work for patch maker Ortho McNeil) say that the number of deaths aren’t unexpected and maintain that the patch is as safe as the pill.
One doctor also pointed out that when dealing with a new drug, rather than one that’s been around for a while, patients and doctors are more likely to contact the FDA when there’s a bad reaction. Other docs said that women shouldn’t get freaked out quite yet and stop using the patch.
Either way, this information certainly warrants further investigation.
Anyone on the patch want to weigh in?
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I am presently on the patch and I have to say that when I saw the report on CBS News last night, it gave me pause.
But I don't feel like my doctor, or even the company, lied to me or misled me in anyway. I read all the paperwork before I tried it. The chances are still so, so small that I'm not particularly worried. I feel badly for the families of the women who are being the guinea pigs.
However, if this becomes more of a problem, I would switch back to pills in a second. I only switched to the patch for convenience. It would just suck if it turned out that this wasn't okay.
I'm an NYU student and when I wanted to switch from the pill to the patch, my Nurse Practitioner advocated the ring (NuvaRing) instead. She said that the clinic wasn't prescribing the patch for exactly the health risks described in this article. I'm glad I'm on the ring.
I stopped using the Patch because I just didn't like it. My skin is sensitive I guess and it caused terrible itching. Aside from that, no problems that I was aware of.
I switched to using NuvaRing as well but I'm not familiar with its safety rates. I would think it works in a similar manner (hormones directly into the bloodstream) so I'm a bit concerned about that as well. If anyone has information on safety rates for NuvaRing, I'd be interested in seeing them.
I'm still on the pill and wasn't interested in the patch but, as someone who works on the clinical side of drug development (industry side) there are a few things about the history and data that I find particularly disconcerting:
#1 the clinical trial data was significant for a three-fold increase of thrombus/embolism for patch users vs pill users. It seems odd to approve a new formulation/delivery method of a medication with this kind of difference in the safety profile - I could see this being justified if comparative delivery methods were invasive or increased risk. I, personally, don't think that the potential difference in increased compliance of a transdermal system vs po delivery (swallowing a tablet) is significant enough to warrant the increased risk.
#2 affected patients from post-marketing surveillance via MedWatch are primarily from those who aren't in the higer risk populations. (I'm not sure if that's the case, but believe it is, in the clinical trial data).
#3 Ortho's hiring of Andrew Friedman shortly after he regained his license (lost due to committing research fraud) looks really bad (I foamed rabidly here). Friedman may have been extremely careful and safety oriented in his time at Ortho, but there's now an appearance of something less than kosher.
This doesn't mean that the patch is, in and of itself, unsafe - there may be confounding factors that the AP's analysis didn't consider (or their people didn't understand). The most important thing is that health care practitioners need to make sure they are clear with patients and ensure all patients (regardless of whether they use hormonal contraceptives) are aware of their risk factors (including family medical history) as well as the signs and symptoms of DVT and embolic events.
I came off depo because it was making my depression worse and I didn't want my bones to thin. I was on the patch for about two months and I absolutely detested it.
The patch was a temporary method for me while I weighed up more long term options (I have a copper IUD now) but it made me feel so awful that I had to stop and switch to the mini pill. I had terrible headaches and felt sick every time I ate. I bloated up and my breasts swelled so much that I thought I was pregnant. It was terrible.
I was on the patch until my insurance coverage changed. The patch became too expensive under my new plan, so I switched back to the pill.
I used the patch for 7 months and loved the convenience and ease. It really stay in place and only having to remember my bc once a week worked much better for me.
I had none of the side effects mentioned above. The only noticeable change was in my sex drive; it really went down. I still greatly enjoyed sex, but the desire to have sex was diminished. Despite this, I would still use the patch if it was an economical choice.
The risks associated with being pregnant are still much more common than the ones that come along with the patch. I'd much rather have the secure feeling of knowing that I haven't forgotten my pill. I can deal with the slightly increased risk of blood clots.
I love the patch because I used to have hellish PMS. We're talking crying at TV ads kinda symptoms, and since I've been on the patch (for about a year now) I've seen my PMS (along with my cramps) get much milder.
Stefanie - I was on the ring for two years and LOVED it, and convinced all my friends use it too. I don't know specifics about serious health risks, I don't think they have done any long-term studies. But since it uses significantly lower level of hormones than the Pill, you could assume it will have lower rates of serious risks. I certainly could feel the lower estrogen - much less side effects. And it's more effective than the pill! I swear I don't work for them, I just love the ring.
Thanks Sara, ITA. LOVE Nuvaring. It's way more convenient than the patch too (once a month!) and I don't even have to look at it. Good point about it having a lower level of hormones.
To the ladies who've tried the nuvaring, could you please tell me more?
I've been on the pill for a few years and have switched brands because of depression and lowered libido. I'm wondering if anyone has experience with both pills and the ring and could tell me about them?
Also, how easy it is to use and any information.
Me and my husband want to wait until i finish school to have a baby, but the changes in my mood due to the pills are so evident. The ones i'm on now (seasonal) have been the best so far, but all the trouble has made me really interested in different options.
Re: nuvaring.
I was on the pill for seven or eight years, and started using nuvaring as soon as it became available in Canada a few months ago. I love it!! I've seen fewer side effects (like mood swings) since starting the ring than I did on the pill, and it's super convenient. I only have to deal with it once a month, which is great, because I was never very good at taking a pill at the same time every day.
It's terrifically easy to use - just pinch the sides together with your fingers and insert the same way you would a tampon. The placement in the vagina doesn't need to be exact, so all you need to worry about is getting it in there, not whether it's in a particular spot or not.
I wrote a longer thing, with more detail about how it works and why I love it. You can check it out here for more information if you'd like it.
Thanks for the info Mochapixie.
That's very helpful.
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