Saturday, October 29, 2011

Increased clot risk for some hormonal birth control

Yaz birth control pills

FDA Details Clot Risk for Birth Control Products
By John Gever, Senior Editor, MedPage Today
Published: October 27, 2011

“Worrisome increases in thrombotic risk associated with hormonal contraceptives are not limited to those containing drospirenone, according to an FDA report issued Thursday.
Compared with hormonal contraceptives with relatively low estrogen doses, norelgestromin/ethinyl estradiol transdermal patch and etonogestrel/estradiol vaginal ring products were both associated with increased risk for venous thromboembolism (VTE), as were birth control pills containing drospirenone, according to the retrospective database analysis.

FDA researchers ran the analysis on records maintained by Kaiser Permanente for members in California and state Medicaid programs in Tennessee and Washington, covering a total of more than 835,000 women who received contraceptive prescriptions from 2001 to 2007.

After adjusting for demographic and other factors, the analysis indicated the following relative risks, with low-estrogen hormonal contraceptives as the reference:

• Drospirenone products: 1.74 (95% CI 1.42 to 2.14)

• Norelgestromin/ethinyl estradiol transdermal patch: 1.55 (95% CI 1.17 to 2.07)

• Etonogestrel/estradiol vaginal ring: 1.56 (95% CI 1.02 to 2.37)

Younger women (those up to age 34) appeared to be at higher risk for VTE for all three product types, the study showed.

And the clotting risk was not limited to VTE -- arterial thromboembolism was significantly increased among women 35 and older taking drospirenone products for the first time.

Thrombosis has long been a concern for hormonal contraceptives of all types and doses. But a number of studies have suggested that the risk differs among the multitude of product types now available.

Drospirenone came into the FDA's crosshairs earlier this year when two studies found that the VTE risk was doubled or tripled relative to levonorgestrel-containing pills.
Previous studies had also identified possible increases in risk associated with the patch and vaginal ring products, although the FDA had not formally announced a safety review, as it had done for the drospirenone products.

All of the previous studies were relatively small and fell short of the quality needed to form the basis for regulatory action, the FDA indicated.

Late last month, after reviewing the preliminary data from the Kaiser/Medicaid analysis, the agency said it still had not reached a conclusion about the degree of risk. That remains the case, according to the FDA this week.

It plans to present all the data to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting on Dec. 8.”

Personal comment: Birth-control pills that contain drospirenone include Bayer's Yaz, Yasmin, Beyaz, Safyral; Sandoz's Syeda and Loryna; as well as Barr Laboratories' Ocella, Watson Pharmaceuticals' Zarah and Teva Pharmaceuticals' Loryna. Etonogestrel is also used in the single rod implant Implanon.

It will be interesting to see what the FDA decides because they have known about the problems with Ortho Evra (the patch) – because of the much higher average estrogen dose - for years and have done nothing more than require warning labels for the product.


  1. I guess this is one reason why you prefer non-hormonal forms of BC and contraception.

  2. Hi Eric, yes clots are one reason that I don’t care for hormonal birth control, but I think the risk is probably being over blown. Out of context doubling the risk sounds very bad, but when the risk is extremely low to begin with say one in five thousand (to pick a number) and with a particular method it doubles, to two in five thousand the risk is still quite small. There is also screening that should be done to see if a woman is a good candidate for a pill; does she have a clotting disorder or is she is sedentary or over weight all of which increase the risk of clots.

    Another thing I don’t like about hormonal contraceptives is that for a lot of us they kill our libido and make it difficult to lubricate naturally. Also, by stopping our normal hormonal cycling birth control hormones can minimize a woman’s creativity which often manifests itself during our estrogen surge when we are fertile. Additionally, for women who aren’t anal about using their method correctly; taking their pills or changing their patch or ring on time or watching to avoid interactions with other meds they are taking, it’s easy to have a birth control failure and find yourself pregnant, especially for very young women who are extremely fertile and not good at keeping track of where they are with their birth control. Ortho Evra (the patch) can fall off and in a bikini everyone can see you are on birth control. NuvaRing can fall out or get hooked on a lover’s penis and pulled out and Depo Provera (the shot) causes bone density loss and weight gain. And even framed IUDs, ParaGard and Marina, can be expelled during a period or after rough sex

    I think for young women who need an extremely effective method of contraception, but who wants to continue cycling naturally to enjoy their natural hormonal surges a copper GyneFix IUD implant is perfect because it’s good for five years and with the new implantation technique the expulsion rate is very low. Of course there is a place for hormonal birth control for women who have very irregular cycles or extremely heavy or painful periods when hormonal intervention can be a godsend.

  3. Is GyneFix approved for use in the U.S. yet by the FDA?

  4. GyneFix is not yet generally available in the U.S, but it is available from clinics just across the border in Mexico.

    Our clinic is participating in a clinical trial over the next few years so our escorts and St Lucy's students who are good candidates for an IUD can get one that way. I think it will probably be at least four years before GyneFix is approved for general use


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