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Blood Clot Risk with Yaz, Other Oral Contraceptives, FDA Warns

FDA warns about oral contraceptives

It’s been known for decades that the use of oral contraceptive pills increases the risk of blood clots, but not all pills present the same degree of risk. A new warning from the Food and Drug Administration (FDA) is an example of this difference, and now the labels on Yaz and nearly a dozen other oral contraceptives will note that they carry a higher risk for blood clots than some other pills.

Oral contraceptives with drospirenone are involved

All of the oral contraceptives named by the FDA contain drospirenone, a synthetic version of progesterone, a female hormone. Drospirenone and other synthetic progesterones are also referred to as progestins.

The FDA has been reviewing study results for nearly a year to determine the safety of oral contraceptives that contain drospirenone. Preliminary information about the FDA’s concerns were released on May 31, 2011, when it noted in a Drug Safety Communication that there were conflicting study results regarding the risk of blood clots when using oral contraceptives that contain drospirenone.

In that communication, the FDA explained that it was “currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills.” The agency also promised to release new safety information as it became available.

On September 26, 2011, the FDA released another communication, stating that “it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-contaiing birth control pills.” By that time, the FDA had finished its review of two 2011 studies that examined the risk of blood clots among users of birth control pills that contained drospirenone, but still had to review another study.

Newest information about oral contraceptives
Now the FDA has made a more solid announcement concerning the use of oral contraceptives that contain drospirenone, yet the agency still has not stated the progestin definitely increases the risk of blood clots (also referred to as venous clotting or venous thrombosis).

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What the FDA has said is that it “has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The degree of that risk varies from about 1.5 to 3 times that associated with other birth control pills.

The oral contraceptives that contain drospirenone include Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah, and two generic formulas. All of these products contain 3 mg of drospirenone and either 0.02 or 0.03 mg of ethinyl estradiol, while Beyaz and Safyral also contain 0.451 mg of levomefolate calcium, which provides the B vitamin folate.

The labels of these products will now reflect the new information about the increased risk of blood clots. According to the FDA communication, the new labels (Beyaz, Safyral, Yasmin, Yaz) will show that some studies reflected as high as a threefold increase in a woman’s risk of blood clots when using oral contraceptives that contain drospirenone compared with products that contain levonorgestrel or other progestins.

Among the other possible risks associated with birth control pills is cancer. The National Cancer Institute notes that some studies suggest the use of oral contraceptives slightly increases the risk of breast cancer, but that the risk potential returns to normal a decade or more after women stop using the Pill.

The Institute also points out that women who use oral contraceptives have a reduced risk of endometrial and ovarian cancer, and that there may be an increased risk of cervical cancer. This latter risk, however, may be because sexually active women are more likely to become infected with human papillomavirus, which causes most cases of cervical cancer.

This new communication from the FDA is both a warning and a reminder to women that not all birth control pills are alike. Women have a choice when selecting an oral contraceptive, and they should discuss those choices with their healthcare professional so they can minimize their risk of blood clots and other risks associated with the Pill.

FDA Drug Safety Communications: April 10, 2012; May 31, 2011; September 26, 2011
National Cancer Institute

Image: Wikimedia Commons