Birth Control Patch Increases Risk Of Blood Clots

[sbk]

Stronger Warning for Birth Control Patch

FDA Strengthens Warning on Blood Clot Risk for Users of Ortho Evra Birth Control Skin Patch

By Miranda Hitti

WebMD Medical News

Reviewed by Louise Chang, MD

Jan. 18, 2008 -- The FDA today strengthened its warning on the risk of serious blood clots in women using the Ortho Evra birth control skin patch.

The warning about venous thromboembolism -- clots in veins that may be life-threatening if they travel to the lungs and cause pulmonary embolism -- isn't new. It's been on the Ortho Evra patch label since September 2006.

What's new is that now, the patch's label no longer notes conflicting information about that risk.

Previously, the Ortho Evra patch's label mentioned mixed results from two studies on clotting risk. One study showed that patch users were twice as likely as birth control pill users to develop venous thromboembolism. The other study showed that patch users and pill users were equally likely to develop venous thromboembolism.

Now, results from a third observational study are in, and that study shows that the odds of developing venous thromboembolism are higher for women who use the Ortho Evra patch than for women using birth control pills.

Today, the FDA ordered the results of that new study to go on the Ortho Evra patch label.

Ortho Evra patch users are exposed to about 60% more estrogen than women who use typical birth control pills, which contain 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including venous thromboembolism, according to the FDA.

In a news release, the FDA states that it "believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options."

The Ortho Evra Contraceptive Transdermal Patch is made by Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson.

[seonai]

In 2006 while I was mostly working in our bar in Thailand, sitting a lot and generally not moving much except to get hubby's lunch/dinner in the village on the bike ... I got a blood clot (DVT) in my left leg... beware all ye island dwellers who use motorbikes to nip to the local shop... not a smart idea

[kat]

Thanks for posting these articles, SBK. I don't use those either.

That sounds nasty, Seonai. Unfortunately, village life doesn't really encourage walking, but that is exactly what you should do. I can't even sit still long enough on the airplane home, and always get up and move around. Stretching and massage is also a good habit to cultivate. Bathing with a natural loofah also helps.

[girlx]

i didn't even know they made a birth control patch!

as for leg clots, seonai how can you tell when you have one? i get pains in my legs at times and worry about that, but don't know how to tell.

[seonai]

Well the symptoms are pains in the calf area if it's a lower clot. If it goes untreated the leg starts to swell from the ankle to below the knee. One way the hospital test initially is to hold your heel and wiggle your calf - you can do this yourself. If your calf moves back and forth freely you should be fine. But if there is any stiffness in the calf you really ought to see a doctor.

The treatment is Heparin to start with (injections in the stomach) and then Warfarin for six months to disolve the clot so that it doesn't move to your lungs or head

[Andiamo]

Well the symptoms are pains in the calf area if it's a lower clot. If it goes untreated the leg starts to swell from the ankle to below the knee. One way the hospital test initially is to hold your heel and wiggle your calf - you can do this yourself. If your calf moves back and forth freely you should be fine. But if there is any stiffness in the calf you really ought to see a doctor.

The treatment is Heparin to start with (injections in the stomach) and then Warfarin for six months to disolve the clot so that it doesn't move to your lungs or head

Thanks for posting the link Sbk - a subject close to my heart.....

I also previously had a DVT following my first and last "direct flight" from the UK to Bangkok. (Now I only ever take non-direct flights! ). After checking in the Hotel and taking a shower, I turned back to look in the mirror at the back of my leg as it was hurting me (as though I'd banged it hard on something...).

The back of my lower thigh had a large black,blue,purple bruise! (about 4cms high and 7cms wide ).

I put it out of my mind and just assumed that I had banged it somehow on the plane as I am a total klutz! However, a DVT was at the back of my mind as prior to my flight (This was 6/7 years ago, it had been on the news all about a young Welsh gal (early 20s who had landed at Heathrow after a flight back from Australia and had collapsed and died - the DVT, turned into a Pulmonary Embolisim and sadly went to her lungs).

I didn't want to think too much as I was on holiday in Krabi, but gradually the calf grew more swollen and the final thing for me was bursting into tears when I had a foot massage! That told me there was something not quite right.

They day before I flew back from Thailand to the UK, I went on the BUPA website and kinda guessed it was a DVT from their explanations and "Physical Stretching Tests". Although at the time, I told myself it couldn't be as I was about to start a new job in the UK, had mortgage commitments etc and decided to take the risk of flying back anyway.......

Hmmm, was not a good idea - felt like my calf was gonna explode and by then it was more than double the size of the other one! (I stood at the back for the whole 13 hours flexing my calves and exercising and thinking that was it! ).

After landing - luckily we lived in South West London at the time, I went straight to my local Doctor who sent me straight to the Hospital where they confirmed:-

1) how stupid I had been to fly back

2) yes it was a DVT

3) after having an ECG, confirmed how lucky I was that the clot hadn't travelled to my heart!

I can confirm what Seonai says, that the initial treatment is Heparin (injections in the stomach) and then Warfarin for six months to dissolve the clot so that it doesn't move to your lungs or head.

Whilst being treated at the Hospital, I was told that I should stop taking the oral contraceptive pill and that I should be careful when i become pregnant. The Consultant at the time, told me that it was probably a combination of things that contributed to the DVT:-

1) Taking the contraceptive pill

2) The direct flight

3) Possible Genetic links

Incidentally, I now also have to have a stomach injection 2 hours before I fly if the flight is 5 hours or longer. This is a preventative measure but still not very nice.

So don't wanna worry you ladies but all those who said to me "Really? But I thought it only happens to old people", well it doesn't!

Be careful ladies. Always walk around on long flights, do leg stretching exercises, wear support stockings, drink loads of water and don't drink alcohol.

(BTW, the BUPA website has some good information about stretching exercises).

Edited February 4, 2008 by Andiamo

[kat]

Wow! That is some serious stuff, Andiamo. I am very glad that you got it diagnosed in time. Actually, I think massaging a clot or DVT once it appears is dangerous. I only listed the above activities in my previous post as a maintenance or prevention routine.

Bad circulation also runs in my bloodline, but I have significantly less problems or visible veins than my biological sister because of working out, stretching, and massage.

I had to get off of the birth control pill very early in my life (19) because I was having severe reactions even on the lowest dosage. I sometimes think this may have had unknown benefits for me at the time.

[Andiamo]

Wow! That is some serious stuff, Andiamo. I am very glad that you got it diagnosed in time. Actually, I think massaging a clot or DVT once it appears is dangerous. I only listed the above activities in my previous post as a maintenance or prevention routine.

Bad circulation also runs in my bloodline, but I have significantly less problems or visible veins than my biological sister because of working out, stretching, and massage.

I had to get off of the birth control pill very early in my life (19) because I was having severe reactions even on the lowest dosage. I sometimes think this may have had unknown benefits for me at the time.

Me too Kat! Mmm, I agree, I don't think you should massage a clot or DVT when you have one as I presume it could probably "break off" and go travelling upwards! Especially if you are not on medication to thin your blood and dissolve the clot.

I'am also very fit, swim and work out a lot - so who knows eh!

Actually, even though at the time I worried about what to do re: birth control, now I think it was actually "meant to be". For sure, I am now a lot more careful about moving around when I travel - be it on a plane, a bus or a train! Plus, it forced me to take charge of my body and learn more about my cycle so all in all, it worked out ok for me!

Just thought I should share cos everybody reads the stories in the magazines but you never think it can happen to you.

Night, night

[Jorinda]

I'm on the patch now, and I read about all the warnings for blood clots. I'm pretty active (I'm forced to walk atleast 3 miles a day if I want to get to classes) and I don't smoke. I know that smoking is one of the risks that you shouldn't take while you're on the patch. You also shouldn't be on the patch if you have a history of blood clots.

Wow close call seonai, I know because of the patch I have to be more careful about blood clots, but I'm planning on moving around a lot during my 24+ hour flight to Bangkok. God I'm not looking forward to sitting on a plane for more than a day.