Should I Be Concerned About Drospirenone and Blood Clot Risk?

I Use Yaz, Yasmin, Beyaz or Safyral - What Should I Do?

Drospirenone_Pills.JPG
Drospirenone Birth Control Pills and Blood Clot Risk. Photo © 2015 Dawn Stacey

QUESTION -- I USE YAZ BIRTH CONTROL PILLS, SHOULD I SWITCH TO A DIFFERENT BRAND BECAUSE OF THE INCREASED BLOOD CLOT RISK WITH DROSPIRENONE PILLS?

In recent years, drospirenone-containing combination pills have been becoming more popular. The birth control pills include Yaz, Yasmin, Beyaz, and Safyral. Part of the reason for their popularity has to do with some of the noncontraceptive benefits they offer.

For women who decide to use the pill for contraception (in addition to pregnancy prevention, both Yaz and Beyaz have been FDA-approved to treat symptoms of premenstrual dysphoric disorder as well as to treat moderate acne. Beyaz also provides women with their daily recommended amount (0.4mg) of folic acid.

Another thing that makes these birth control pills different is that they contain the progestin drospirenone. This progestin can suppress the flow hormones that regulate your body's water and electrolytes. Drospirenone could also lead to higher potassium levels and/or have interactions with other medications that increase potassium. There is also concern that using birth control pills that contain drospirenone may increase your blood clot risk as compared to birth control pills that contain a different progestin.

    ---> Beyond Birth Control: Yaz and Beyaz

It is important to point out that all birth control pills pose a risk of developing blood clots.

Blood clots that form in a deep vein in the body are called deep vein thrombosis (DVT). DVT is a rare birth control pill side effect and could block blood flow. A pulmonary embolism can then occur if a blood clot breaks loose from the vein and moves through the body into the lung. This can lead to death.

ANSWER -- NO NEED TO PANIC. YOU JUST SHOULD BE AWARE OF THE FOLLOWING:

The FDA has been researching the potential link between drospirenone and blood clot risk. The agency conducted its own self-funded study looking at data from over 800,000 women. In October 2011, the FDA released the results of this study and exhibited concern over a potential 1 1/2-fold increase in the blood clot risk for women who use drospirenone pills.

In an April 2012 advisory, the FDA announced that the agency had finished its review of existing observational and epidemiologic research regarding drospirenone and blood clot risk. Based on this review, the FDA concluded that drospirenone-containing birth control pills may be linked to a higher blood clot risk and called for new labeling requirements on these pills. However, the agency also pointed out that this research did not yield consistent results or account for significant patient characteristics that could also contribute to blood clot risk. Though the FDA indicated that there may be a link between drospirenone and blood clot risk, they also declared that the agency is still not certain that this increased blood clot risk is actually due to the drospirenone in these birth control pills.

What Does Drospirenone and Blood Clot Risk Mean to Me?

At this point, there is no need to panic if you are currently using a birth control pill that contains drospirenone. The FDA advises that:

The FDA has also instructed doctors to consider the risks and benefits of drospirenone-containing birth control pills and a woman's risk for developing blood clots before prescribing these pills.

If you use a drospirenone birth control pill like Yaz, Yasmin, Beyaz or Safyral, you should be aware of the following:

  • If you are scheduled for major surgery, you should stop using your drospirenone-containing birth control pills at least four weeks before your operation and wait two weeks afterwards to begin using them again.
  • It would also be helpful that you are able to recognize the symptoms of blood clots. These could include severe chest pain, persistent leg or arm pain (with possible swelling, warmth and redness) and/or sudden shortness of breath. If you find yourself experiencing any of these symptoms, you should immediately call your doctor.
  • If you are confined to bed rest or a cast or will be traveling long-distances (4 or more hours), you may have a higher chance blood clot risk.
  • If you smoke, are over 35 years old and use any combination birth control pill, the risk of you experiencing serious cardiovascular events, like blood clots, increases.

Other Reasons Why You Should Double-Check With Your Doctor:

Because of this potential increase of blood clot risk, it may also be a good time for you to double-check with your doctor that a combination birth control pill containing ethinyl estradiol and drospirenone is the best option for you. Because drospirenone may increase levels of potassium or interfere with medications that increase potassium, your doctor should be monitoring your serum potassium levels in the first month of use if you are also being treated with any drug associated with potassium retention. These drugs could include:

  • Potassium supplementation ACE inhibitors (Vasotec, Capoten, Zestril and others)
  • Aldosterone antagonists
  • Potassium-sparing diuretics (spironolactone and others)
  • Heparin
  • NSAIDs (ibuprofen [Motrin, Advil], naproxen [Aleve and others] when taken long-term and daily for treatment of arthritis or other problems)
  • Angiotensin-II receptor antagonists (Avapro, Cozaar, Diovan and others)

Additionally, if you are currently using Yaz, Yasmin, Beyaz or Safyral and have any of the following conditions, you may want to talk with your doctor to make sure that this is the safest birth control option for you:

  • Uncontrolled high blood pressure
  • A history of blood clots in your legs, lungs or eyes
  • A history of adrenal disease, kidney disease or liver disease
  • Have diabetes with kidney, eye, nerve or blood vessel damage
  • Had a heart attack, stroke or a history of serious heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart

DROSPIRENONE AND BLOOD CLOT RISK -- THE BOTTOM LINE: 

Overall, if 10,000 women (who are not pregnant and do not use birth control pills) are followed for one year, between 1 and 5 of these women will develop a blood clot. Even though you may be at a greater risk for blood clots if taking a drospirenone birth control pill, I would like to remind you again that using any combination oral contraceptive can put you at risk for developing blood clots.

The risk of venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) in women using any type of combination rap contraceptive is rare and has been estimated to be 3 to 9 per 10,000 women (per year). This risk is highest during the first year of use (especially during the first 6 months). The greatest risk of venous thromboembolism seems to be after you initially start taking a combination pill or restarting the same pill or a different brand (if it has been more than 4 weeks since you last used the pill).

You and your doctor should weigh the risks of blood clots (and other side effects) against the benefits of the pill (both for pregnancy prevention and non-contraceptive advantages).  

All that being said, it is important that you keep this blood clot risk in perspective: the total overall risk of developing a blood clot is very low. Even though you have a higher blood clot risk if you use the pill (versus not using hormonal contraception), this risk is still lower than the blood clot risk associated with pregnancy or after giving birth:

  • Blood clot risk for women of reproductive age who don't use the pill (1-5 cases per 10,000 women)
  • Blood clot risk while using combination birth control pills (5-7 cases per 10,000 women)
  • Blood clot risk while taking pills with drospirenone (9-12 cases per 10,000 women)
  • Blood clot risk while pregnant (increases to 29 per 10,000 women)
  • Blood clot risk during postpartum/12 weeks after giving birth (reported as high as 40-65 per 10,000 women).

Sources:

American College of Obstetricians and Gynecologists. "Risk of venous thromboembolism among users of drospirenone-containing oral contraceptive pills." Committee Opinion No. 540. Obstet Gynecol 2012 (Reaffirmed 2014);120:1239–42. Accessed via private subscription.

FDA. [4-10-2012] "Updated External Questions and Answers – Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots." Accessed 1/27/15.

FDA. [10-27-2011] "FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone." Accessed 1/27/15.

James AH. "Pregnancy-associated thrombosis." Hematol 2009; 277-85. Accessed via private subscription.

PubMed Health. "Media hype blood clot risk of birth control pills." US National Library of Medicine/National Institutes of Health. 03 Feb 2014. Accessed 1/27/14.

Continue Reading