Although the FDA cautions that the risk of developing blood clots while taking certain oral birth control pills is low, they have decided to move forward in requiring certain birth control pills to label the risk. The updated label warning is part of a new regulation put in place by the FDA to inform female consumers that the risk of developing blood clots from some birth control pills is slighter higher today than the older forms of the pill. Some of the brands required to list the warning include Yaz, Yasmin, Safryal, Beyaz, Gianvi, Loryna, Ocella, Syeda, and Zarah.
Mayo Clinic states that blood clots that form in response to an injury or a cut are beneficial, stopping potentially dangerous bleeding. However, a number of conditions can cause you to develop blood clots in critical locations, such as your lungs and brain, and they require medical attention and can be fatal. Some of the symptoms of blood clots include swelling, difficulty breathing, cramps or skin discoloration.
The new labeling, as ordered by the FDA, will detail recent studies suggesting that pills that contain drospirenone can carry a slightly higher risk of blood clots than other birth control pills. Drospirenone is a synthetic form of progesterone, a female hormone. While some studies showed that the synthetic hormone increases the risk of blood clots as much as 3 times, other studies found no such link. Some studies show the risk of blood clots is higher in women taking these types of birth control pills than those who don’t, however, the overall risk of blood clots is still relatively low.
Bayer HealthCare, makers of Yaz, updated their website to include an interstitial that reads: “In cooperation with the Food & Drug Administration (FDA), Bayer has updated the product information for YAZ. Women who use birth control pills with drospirenone (like YAZ) may have a higher risk of getting a blood clot. Some studies reported that the risk of blood clots was higher for women who use birth control pills that contain drospirenone than for women who use birth control pills that do not contain drospirenone. Blood clots can be life threatening or lead to permanent disability. Talk to your healthcare provider about your risk of blood clots before deciding which Pill is right for you.”
Advisers to the FDA voted in December that the benefits of the drospirenone-containing birth-control pills outweigh the risks and recommended a label change to better reflect the potential for blood clots. It is suggested that women talk to their doctors about their risk before deciding on an oral contraceptive.