Are you thinking about using the NuvaRing, the birth control vaginal ring? If so, take note: health experts say that women wanting to use NuvaRing because of its effectiveness and convenience must balance these qualities against the fact that the contraceptive may pose a higher risk for blood clots.
The world’s first when it was approved by health regulators in 2001 and hailed as a “no-muss/no-fuss alternative” to the birth control pill, NuvaRing is currently facing a massive, multidistrict federal case in the United States over safety issues. Trials are scheduled to begin this year.
For sure, unlike oral contraceptives, which require taking a pill at the same time every day, NuvaRing is convenient contraception. Inserted just once a month, it is left in the vagina for three weeks, where it delivers hormones directly into the bloodstream.
This convenience has made NuvaRing one of the world’s most popular forms of non-pill birth control: In the U.S. alone, doctors prescribed more than 5.5 million prescriptions in 2010, according to health-care information company IMS Health. That same year, NuvaRing generated US$559 million in global sales for its maker, Merck.
But safety concerns over NuvaRing have spread in recent years. Claiming NuvaRing has caused them potentially life-threatening blood clots, more than 700 women have filed lawsuits since the contraceptive hit the market in 2002. The women are suing Merck for not disclosing the ring’s health risks fully, and their cases have been consolidated into a massive, multidistrict federal case.
As of May 2011, almost 1,000 cases of possible NuvaRing-related blood clots have been reported to the U.S. Food and Drug Authority.
Health experts say all hormone-based birth control drugs increase the risk of clotting, and this is further complicated by smoking, obesity or family history.
The first generation of pills manufactured in the 1960s contained enough estrogen to raise the risk of clots more than ninefold.
Second-generation contraceptive safer?
But a second generation of pills developed in the 1970s, containing a smaller dose of estrogen combined with newer forms of synthetic hormone progestin, such as levonorgestrel, norethisterone and norgestrel, were found to be just as effective and safer.
Still, drug makers sought to market novel products. They created a third generation of hormonal contraceptives that contained desogestrel or ethinyl estradiol that helped lessen facial hair and control acne outbreaks. NuvaRing belongs to this generation.
A fourth-generation progestin, drospirenone, used in the top-selling but controversial oral contraceptives Yaz and Yasmin, is effective and is said to alleviate symptoms of pre-menstrual syndrome.
But a number of studies say that third- and fourth-generation contraceptives—along with NuvaRing—raise the risk of blood clots without adding any benefit.
In 2009, the British Medical Journal published two studies of desogestrel and fourth-generation progestins that showed just that: According to the findings of both studies, women taking third- and fourth-generation hormonal contraceptives were almost twice as likely to get a blood clot than those who took second-generation contraceptives.
“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?” said Dr. Fritz Rosendaal, an epidemiologist at Leiden University Medical Center in the Netherlands, co-author of one of the studies that found a higher risk for clots in NuvaRing than in second-generation birth control. Dr. Rosendaal has contributed to more than a dozen scientific papers on desogestrel.
Two years earlier, in 2007, the consumer watchdog Public Citizen’s Health Resource Group petitioned the FDA to ban oral contraceptives containing desogestrel, saying these were not safe.
Because NuvaRing was new at that time, it wasn’t named in the petition. But Public Citizen’s director Dr. Sidney Wolfe explicitly concluded: “We’ve told people not to use these drugs and have advised women that the safest contraceptives are the older, second-generation ones.”