Oral Fixation: Is the Latest Birth Control Too Risky?

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When a woman goes on birth control, her risk level for a number of health issues—weight fluctuations, waning sex drive, spotting between periods, headaches, and blood clots, to name a few—becomes elevated. That’s not to say that every one of the millions of women around the world currently on the Pill or some version of it will experience these problems. (That depends more on lifestyle, family history, and so forth.) Even so, users accept these risks, however minimal they might be, for the positives associated with birth control—not the least of which is its power to prevent pregnancy by almost 100 percent when taken as prescribed. Birth control can also bring about lighter periods with fewer associated aches and pains. But the negative side effects are still a cause of concern for many women.

Women need birth control options that are as safe as possible, which is why medical scientists over the years have created synthetic hormones meant to curb any possible ills. In fact, one newer type of hormone found in oral contraceptives—specifically, desogestrel in the United States—was released on the market in the 1980s and ’90s to do just that. Unfortunately, with its release came numerous warnings about its danger—namely, that it significantly increases users’ risk of a scary health issue: venous thrombosis (VT), or blood clots forming in veins. If left untreated, blood clots can travel through the bloodstream and into the heart, lungs, and brain, possibly leading to a fatal embolism.

Because of this, one organization called Public Citizen has actually petitioned the FDA to ban third-generation hormones, like desogestrel, completely. Women who take any oral contraceptive already have a higher chance of developing blood clots by as much as fourfold, according to some studies. So if that risk increases even more with these new hormones, does that mean women should avoid them altogether?

A Rocky Start to the Third Generation
Since its inception in the 1960s, the Pill has always been a controversial form of birth control because of the way its hormonal influxes affect the body. Public outcry over the first generation of pills, whose high concentrations of estrogen greatly increased blood-clot risk, led medical scientists to combine synthetic versions of estrogen and progesterone (otherwise known as progestin) with the second generation a decade later. When consumers complained about the side effects associated with those contraceptives, such as acne and weight gain, scientists released third-generation progestins that were supposed to be safer. In the United States, these are found in birth control options like Mircette, NuvaRing (a contraceptive inserted vaginally), Ortho-Cept, and Cyclessa.

Soon after desogestrel hit the market, reports circulated linking it and other, newer hormones (like gestodene, which is not FDA approved) to elevated incidents of venous thrombosis (VT). Some studies showed that women taking it were two to three times more likely to develop blood clots than those on earlier progestins, like levonorgestrel. In 1995, the Committee on Safety of Medicines in Britain advised women to avoid these contraceptives if their VT risk factor was already higher than average; that warning led to a marked decrease in third-generation users in the UK the following year. The controversy continues years later: Public Citizen asked the FDA to ban these progestins in 2007, and numerous lawsuits are currently pending against the makers of NuvaRing, in particular regarding blood-clot and stroke occurrences.

As if the elevated VT risk weren’t bad enough, there’s some evidence that the newer generation of hormones doesn’t minimize side effects like it was created to do in the first place. The FDA has warned Mircette about its advertisements, which purport that taking Mircette offers benefits that haven’t been scientifically proven. In a 1998 letter to Organon, the maker of Mircette, the FDA called such ads “false and misleading without substantiation by adequate and well-controlled trials.” In other words, Mircette and company’s ability to actually reduce migraines and period side effects isn’t a proven fact.

Studies Support Both Sides of the Argument
The Public Citizen petition, which four medical doctors signed and which claims to represent thousands of consumers, cites the FDA letter, as well as several studies over the past twenty years that have associated more risks with desogestrel and the like than with levonorgestrel. One of them, a 2000 study published in the British Medical Journal, actually shows less VT cases when user levels dropped in the UK in 1996. But research in general has shown more mixed results than what the petition presents—especially when comparing different progestins.

A 1996 study also published in the BMJ found that the risk of VT is slightly greater only among third-generation users versus their second-generation peers—twenty cases per million users within a year, compared with fourteen. If you’re thinking that twenty cases out of one million users is a pretty small fraction, you’re right. Paul A O’Brien reached a similar conclusion in his 1999 review of related studies, writing that the risk of blood clots among users is “real and measurable,” but “also small in absolute terms.”

It’s also possible that other factors might play more of a role than we realize. O’Brien concluded that the women who were most at risk were those taking oral contraceptives for the first time. Researchers of a five-year-long study published in 1998 regarding incidents of deep vein thrombosis and pulmonary embolisms among women found that it was the amount of time they were on birth control that put them more at risk, not which hormones they took.

The Takeaway: Find Out What’s Right for You
Clearly, research varies when it comes to third-generation hormones, which makes the question of whether they should be available to consumers or not a very confusing and contentious one. However, one thing’s certain: women on any kind of hormonal contraceptive are at risk for blood clots. Smoking, obesity, and family history raise the risk factor as well. But eschewing all birth control to avoid VT isn’t necessarily the best option, either, considering that pregnancy increases the likelihood of blood clots even more than desogestrel might.

Ultimately, any woman either considering or already using birth control should talk with her doctor about all potential risks of using any kind of hormone-based contraceptive. Even though third-generation hormones are controversial as of late, second-generation ones present their own issues that could be just as serious for some women. For example, research out of the Netherlands presented at the 2002 International Stroke Conference showed that the risk of stroke was actually about the same in second- and third-generation pills. Both have their downsides, though it’s worth noting that desogestrel’s purported upside—reducing other negative side effects—has yet to be shown. Perhaps that makes the slightly elevated risk an unnecessary one to take, but that’s for women to decide with the help of trusted medical professionals.

Paul A. O’Brien made a similar distinction between older and newer hormones in his 1999 review, writing, “It is not that third-generation contraceptives are unsafe—it is just that we have something safer.” Maybe that’s what it comes down to with contraceptives that use newer forms of hormones. For some women, using NuvaRing or Cyclessa won’t pose any problems. Others might have a different experience, but whether that calls for a total ban is a question better left to medical-industry experts, and it’s one that’ll probably be answered somewhere down the line, when lawsuits are settled and more conclusive research is available for review. But as to whether women should consult their doctors about all forms of birth control and make a decision based on both the evidence presented and their own individual risk levels? That’s a resounding “yes.”


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