Is Your Birth Control as Safe as You Think?
Since NuvaRing hit the market, more than 700 women have filed lawsuits, claiming it has caused potentially life-threatening blood clots. The battle may change the way millions of women prevent pregnancy.
• When it was approved by the FDA in 2001, NuvaRing became the world's first vaginal birth-control ring. Inserted just once a month, it dispenses hormones directly into the bloodstream. Unlike oral contraceptives, which require taking a pill the same time every day, NuvaRing is marketed as a pill-free, no-muss/no-fuss alternative. Just pop it in and forget about it (the ring remains in for three weeks and comes out for a week during your period). That pitch clearly resonated with women. Last year, NuvaRing generated $559 million in international sales for Merck.
It's worth noting that all hormonal birth control with added estrogen carries a risk of blood clots. In the 1960s, the estrogen used in the earliest pills raised the risk of clots more than ninefold. A decade later, a second generation of pills containing a much gentler dose of the hormone, coupled with the synthetic hormone progestin, had been developed. Though these second-generation pills are effective and safe, drugmakers have sought new forms to market as better able to control conditions like facial hair and acne. NuvaRing contains a version of the third-generation progestin desogestrel. There's even a fourth-generation progestin, said to alleviate symptoms of PMS; it's the essential component of Yaz and Yasmin, two top-selling oral contraceptives.
The problem? Some researchers say third- and fourth-generation contraceptives — including those containing desogestrel — raise the risk of blood clots without adding any benefit. In 2007, the consumer watchdog group Public Citizen petitioned the FDA to ban oral contraceptives containing desogestrel. Although NuvaRing wasn't named in that petition because it was still fairly new, the director of Public Citizen's Health Resource Group, Dr. Sidney Wolfe, reached an unequivocal conclusion: "We've told people not to use these drugs and have advised women that the safest contraceptives are the older, second-generation ones." The FDA didn't act on Public Citizen's claims, even though during its own review process, the agency concluded that NuvaRing's label should "clearly reflect safety concerns about an increased risk" for blood clots.
In 2009, the British Medical Journal published two investigations of desogestrel and fourth-generation progestins that seemed to bolster critics' concerns. Both studies found that women taking third- and fourth-generation pills were almost twice as likely to get a blood clot than those who took second-generation contraceptives. Frits Rosendaal, Ph.D., an epidemiologist at Leiden University Medical Center in the Netherlands who has contributed to more than a dozen scientific papers on desogestrel, coauthored one of the studies that found a higher risk for clots in NuvaRing than in second-generation birth control. "To me, it's incredible that [Merck] used desogestrel and not a second-generation progestin. Why not go for the one with the lowest risk?" says Rosendaal.