Think Twice About Third-Generation Oral Contraceptives and YASMIN

Two large new studies have found increased risk of blood clots in women using the oral contraceptives that contain drospirenone, such as ethinyl estradiol with drospirenone (YASMIN).

Both studies, one from the Netherlands and one from Denmark, also confirmed that oral contraceptipve pills containing desogestrel (see Table 1) can increase the user’s risk of life-threatening blood clots compared to women taking second-generation birth control pills.

The new finding in both studies was a significantly increased risk of venous blood clots in women using drospirenone-containing pills; in the studies, YASMIN was the main drug of this type tested. The increased blood clot risk for pills containing drospirenone, compared with the older second-generation pills, was 1.64 (Danish) and 1.7 (Dutch) times higher in the two studies.

Blood clots typically form in a patient’s leg veins, but they can then travel to another part of the body and block blood flow. Blood clots that travel and block blood flow to the lungs are known as pulmonary embolisms, a condition that can be fatal.

Since 1999, we have urged readers of Worst Pills, Best Pills News not to use desogestrel-containing oral contraceptives because they double the risk of potentially life-threatening blood clots (compared to women taking second-generation oral contraceptives) but do not protect women against pregnancy better than other, safer alternatives. Using desogestrel-containing oral contraceptives also does not help the user avoid the side effects of second-generation oral contraceptives, such as unwanted hair growth or acne.

The new Dutch and Danish studies confirmed older findings of a significantly higher risk of blood clots in women using oral contraceptives containing desogestrel or gestodene (the latter ingredient is not available in the U.S.). The increased risk of blood clots was two times higher in the Dutch study and 1.8 times higher in the Danish study than in women using pills with the older, safer second generation progestins (see Table 3).

We fully agree with the authors of the study from the Netherlands who stated that:

Our results clearly show that the safest option with regard to the risk of venous thrombosis is an oral contraceptive containing levonorgestrel combined with a low dose of oestrogen.

What is the difference between second- and third-generation oral contraceptives and drospirenone? Most oral contraceptives contain a combination of hormones — estrogens and progestins. The most commonly used estrogen in combined oral contraceptives is ethinyl estradiol. Second- and third-generation oral contraceptives differ only in the progestin they contain.

Second-generation oral contraceptives have been on the market longer than third-generation oral contraceptives. They contain norgestrel, levonorgestrel, norethindrone or norgestimate. Studies showing increased risk of third-generation contraceptives are almost exclusively limited to desogestrel.

Newer, third-generation oral contraceptives sold in the U.S. contain the progestin desogestrel. Another, even newer, progestin is drospirenone, found in YASMIN and also in YAZ, the newer, lower-estrogen version of YASMIN.

YASMIN was approved by the Food and Drug Administration (FDA) in 2001. In 2008, more than 5 million prescriptions for the drug were filled in the U.S.

However, we have been warning our readers not to use YASMIN since 2002 because drospirenone causes elevated blood levels of potassium that may cause serious heart and other health problems. These problems may include a change in acid balance of the blood and muscle weakness.

YAZ, which has the same amount of drospirenone as YASMIN but a smaller dose of estrogen, was not examined in the Dutch or Danish studies because it was not on the market there for most of the period covered by the studies.

We have been active in warning women against using newer forms of birth control because they carry additional and unnecessary risks for the women who use them.

In early 2007, due to the release of studies confirming the additional risk posed by desogestrel, we petitioned the FDA to ban third-generation oral contraceptives containing desogestrel.

At the time of our petition, we explained these risks in a YouTube video on the Web site NotMyPill.org. On this site, readers could choose to join our petition to the FDA to ban these uniquely dangerous oral contraceptives. As of press time, more than 20,000 individuals had signed the petition, and 22,000 people had viewed the video on YouTube. But in the 2½ years since it was filed, we have not had any substantive response from the FDA to our petition.

What You Can Do

If you are taking an oral contraceptive that contains drospirenone or desogestrel, talk to your doctor about your birth control options. The safest alternatives are second-generation pills that contain low-dose estrogen and levonorgestrel, norgestrel or norethindrone such as the combination levonorgestrel and ethinyl estradiol, or the brand names LEVORA and TRIVORA.

Do not stop taking your pills suddenly. Follow your doctor’s instructions for switching birth control to make sure there is not a chance of pill failure.

Table 1. Third-Generation Oral Contraceptives Containing Desogestrel Currently Available in the U.S.
Generic Name: Ethinyl Estradiol with Desogestrel

Table 2. Oral Contraceptives Containing Drospirenone Currently Available in the U.S.
Generic Name: Ethinyl estradiol and drospirenone

Table 3. Second-Generation Oral Contraceptives