New Birth Control Pill Warning Labels: What You Need to Know

Healthy SELF, SELF Magazine

April Daniels-Hussar,SELF magazine

The Food and Drug Administration (FDA) announced Tuesday that it will require certain birth control pills to come with a warning label because they carry a higher risk of potentially life-threatening blood clots than other pills.

As HealthySELF reported back in December, the FDA announced at that time it was considering requiring the warning labels, based on evidence that newer forms of birth control, such as Yaz, which use a hormone called drospirenone, appeared to have a higher likelihood of causing life-threatening blood clots than older forms of birth control that use a different type of hormone: the progestin, levonorgestrel.

Now, they've completed their review of what they call "recent observational studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills," and they've made their decision. "Based on this review," states the FDA website, "FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills."

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Yaz is one of the most well-known brands that will be required to carry the warning labels -- other brands include Beyaz, Safyral and Yasmin. According to the FDA, "The revised labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk."

How much danger is there? "To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period," states the FDA.

According to Dr. Suzanne Gilberg-Lenz, an OB-GYN in Beverly Hills, Calif., if you're taking any kind of birth control pill, you should thoroughly discuss the personal risks, benefits and alternatives with your health care professional. Regarding the new labeling decree, Lenz clarifies that the FDA is addressing the increased risks associated with drosperinone specifically, "and is NOT making a blanket statement about ALL oral contraceptive pills."

There are, of course, a variety of birth control pills and brands available on the market. Most (except for the "mini-pill") contain estrogen -- the main difference between them, explains Gilberg-Lenz, is what kind of progesterone they also contain, and their dosing schedule. Here's how a few popular brands compare:

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Yaz and Yasmin both use drosperinone along with the estrogen ethinyl estradiol, with the same hormonal dosage throughout the cycle. Yasmin has a hormonal cycle of 21 out of 28 days (the last week of pills are placebos). Yaz, according to Gilberg-Lenz, contains a lower dose of estrogen and extends the hormonal cycle to 24 days out of 28, with the goal of less breakthrough bleeding and less of a hormonal withdrawal.

Ortho-Cyclen uses a progestin called norgestimate and the same estrogen (ethinyl estradiol) as Yaz and Yasmin, and delivers an even hormonal dosage for 21 days out of the 28-day cycle.

Ortho-Novum is the same as Ortho-Cyclen except the progestin used is called norethindrone.

Ortho TriCyclen Lo uses the progestin norgestimate (same as Ortho-Cyclen), but it is a triphasic birth control pill, which means that it delivers a different level of hormones for three weeks (white, light blue and dark blue pills) and no hormones for one week (green pills). During each of the first three weeks, the level of progestin increases.

The "mini pill" contains a low dose of progestin, which thickens cervical mucus to prevent pregnancy, and has no estrogen at all. Because it is such a low-dose pill, you have to take it at the exact same time every day for it to be effective. The hormone dosage is the same through the cycle and lasts either 21 or 28 days.

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When it comes to choosing the right one for you, Gilberg-Lenz says that it's a matter of really evaluating, along with your health care practitioner, what makes the most sense for your individual needs. As far as the blood clot risk, both Gilberg-Lenz and the FDA both point out that some of us are at greater risks than others -- known factors that increase the risk of a blood clot include smoking, being overweight and a family history of blood clots, in addition to other factors, like frequent travel.

According to the FDA, the symptoms of a blood clot include persistent leg pain, severe chest pain or sudden shortness of breath.

The bottom line is that you need to be fully informed and work with your gynecologist to pick the best birth control option for you. "This is also a very good reminder to women that there truly are risks, benefits and alternatives to EVERY SINGLE healthcare decision they make, especially when it involves using a pharmaceutical," says Gilberg-Lenz. "Think critically about what you put in your body -- make educated decisions, not fear-based and not without thinking or discussing them thoroughly with your provider." And if your provider won't make time to talk? Gilberg-Lenz says, "Find another one!"

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