Understanding the new FDA warning on popular birth control

This week the Food and Drug Administration announced a change in the warning label of specific types of birth control pills, because consumers may be at an increased risk for blood clot development. The changing of the warning label is not a cause for immediate alarm, however, the facts behind this new warning label should definitely spark a conversation between you and your physician if you are a birth control pill consumer.

The pills under scrutiny contain the hormone drospirenone, a synthetic version of the female hormone progesterone. Popular brands that contain this hormone include Bayer’s Yasmin, Yaz, Beyaz and Safyral as well as several other brands such as Gianvi, Loryna, Ocella, Syeda and Zarah. These particular oral contraceptive formulations have been highly popular in the past several years, with Yaz being one of the top-selling U.S. contraceptives.

The risk for blood clots is nothing new for birth control pills; the warning label has been in place for years. Most pills contain a combination of estrogen and a progesterone, or a synthetic form of progesterone, commonly known as progestin, such as levongesterel or drospirenone. These hormones in birth control pills put women at a higher risk for the development of blood clots compared to non-pregnant women not taking birth control pills. The increased risk for blood clot formation in pill users normally range anywhere from 3 to 9 women-per-10,000. This reason is why pill use is discouraged in women who are already at a higher risk for blood clot formation, such as women who smoke, are obese or have certain blood clotting disorders.

This recent FDA warning is based on a FDA review of several studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on the review, the FDA has concluded that these particular pills may be associated with an even higher risk for blood clots than other progestin-containing pills.

The studies reviewed by the FDA, however, have conflicting results. While some studies show a three-fold risk of blood clots in drospirenone-containing pills, others found that there is no increased risk. Despite these conflicts, the FDA still believes it is necessary to require this new warning label in all drospirenone-containing pills.

The most important thing that I recommend is to talk to your doctor about your risk for blood clots before deciding which birth control method to use. Factors such as a family history of blot clots, smoking or being overweight can increase your risk for blood clot development and should be discussed with your doctor. The fact that these particular pills may have a higher risk for the development of blood clots paired with the FDA’s concern should be warning signs to consumers. Also note, however, that the current studies are conflicting and there will likely be more decisive research developing over the next several years. Your physician can help you weigh the risks and benefits of your birth control method, and birth control users should keep an eye out for future blood clot related studies.

As seen in The Tulane Hullabaloo, 4/13/2012