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Did FDA Consider Factor V Leiden Risk When Updating Yasmin Blood Clot Risk?

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Washington, DCGiven the media and medical scrutiny over Yasmin birth control, and the concern over the apparent role of drospirenone for increased potential of a blood clot or Yasmin DVT (deep vein thrombosis), most people are reasonably versed in the possibility of adverse health issues through the use of the new-age birth control pill.

Even the US Food and Drug Administration (FDA) is concerned enough about the potential for increased blood clots to mandate a change to prescribing labels for all birth control pills containing drospirenone. That happened last year.

All birth control pills - even traditional products that have been around for 50 years or more - carry a slight risk for blood clots. That’s a point echoed by Yasmin manufacturer Bayer, in defending its still-popular portfolio of third-generation birth control pills that appeal to younger women due to various added benefits. Bayer’s point is that all birth control pills carry a risk for blood clot and thus, Yasmin is no different. While various studies have concluded there is a higher risk for blood clot amongst birth control pills based on the drospirenone formulation than those that are not, the risk is not a complete slam-dunk and doctors are still divided on the subject. The FDA is being cautious, in the absence of any intent for banning drospirenone-based contraceptives from the market altogether.

However, did the FDA - in its cautionary stance - consider Factor V Leiden?

What is that, you ask?

Factor V Leiden is a super-clotting gene that one in five Caucasian women have. Most women don’t even know they have it - and while there is a test available to determine whether or not a woman has the Factor V Leiden gene, it is apparently not routinely administered.

The concern is that women who carry this gene are 35 times more likely to experience a blood clot from taking oral birth control. When use of Yasmin birth control is factored in, and the corresponding increased risk for Yasmin blood clots through the presence of drospirenone, the danger for women carrying the Factor V Leiden gene spikes dramatically.

Yasmin and Yaz lawsuits alleging grievous Yasmin side effects (and also Yaz side effects, since the products are similar and both contain drospirenone) continue to grow. Bayer has been undertaking to settle the lawsuits, but shows no inclination to remove its best-selling products from the market. The FDA continues to remain content with a cautionary warning.

However, any Caucasian woman considering the adoption of Yasmin birth control, should first establish the possibility of the Factor V Leiden gene, and undergo testing.

For any woman carrying the Factor V Leiden gene - regardless of age - the risk of Yasmin blood clots for you just went way, way up…

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READER COMMENTS

Posted by

on
I was also put on birth control after I had my daughter and also unbeknownst to me I had Factor V too. I had a brain hemorrhage caused by a blood clot which caused a seizure. It was the most terrifying experience of my life. I've been through hell the last year dealing with all of this. I was on Yasmin at one point thinking it was a miracle drug! It could have killed me. I think it should be standard protocol to test women for Factor V before putting them on estrogen therapy if they know it could damage them. It's just a blood test.

Posted by

on
I was on the birth control pill back in 2002, after I had my daughter. I had no idea I have Factor V Leiden Heterozygous Mutation. when I was diagnosed with the multiple dvts from ankle to thigh, every vein plastered is when I found out I have Factor V Leiden. I sure wish they tested me back then before they put me on it. I never heard of it until then. cant help but wonder if my life would be different now. Maybe I would not have post thrombotic syndrome in my left leg. or be on life long Xarelto, and maybe could have had more children. because if I knew, I would not have gone on the pill in order to avoid blood clots.

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