Manufacturer Organon—bought in 2007 by Schering-Plough, which is now merging with Merck—promotes the first-of-its-kind contraceptive with magazine ads proclaiming, "Let Freedom Ring." Its ubiquitous TV spot, a play on Busby Berkeley musicals, features synchronized swimmers posing as birth control pills. "Maybe it's time to break free from the pack," the voice-over suggests as the women abandon their repetitive routine.
The company also relies on Facebook ads and a girlfriend-to-girlfriend approach to overcome squeamishness about inserting the ring. It has even bought product placements on Scrubs and other shows. More than a million American women have responded
Making birth control easier is, of course, a good thing. But for years there have been serious safety questions about the "third generation" hormones used in NuvaRing and several other contraceptives on the market—questions that NuvaRing's labeling sidesteps by saying that it is "unknown" how the device compares to other hormonal birth control.
While all hormone-based contraceptives increase a woman's chance of developing blood clots (which also cause strokes), this effect is more common with some than with others. The riskiest ones employ third-generation hormones, like desogestrel. (The ring uses a related compound.) These pills (brands such as Desogen, Mircette, and Cyclessa) were developed in the 1980s to lessen the pill's minor side effects, like acne and facial hair. Although ineffective at this—a point the fda acknowledges—and no better as birth control, either, the pills remain on the market.
But since at least 1995, research has shown that these newer pills double the blood-clot risk of earlier, "second generation" pills, such as TriNessa and Estrostep. In 2007, the consumer group Public Citizen petitioned the FDA to ban third-generation pills. (The feds have taken no action thus far.)
NuvaRing actually contains a lower hormone dose than most oral contraceptives, a fact its ads emphasize. But while birth control pills lose up to half their hormones in the digestive tract, the ring's dose is absorbed directly into the blood. Its package insert says there are no data on whether this route makes NuvaRing any riskier than taking pills. But that, say lawyers suing the company, is because Organon never studied the question before it marketed the ring. Nor did the fda demand it—the agency based its approval largely on studies involving pills.
Since 2001, when the FDA green-lighted NuvaRing, the agency has received reports of at least 300 serious adverse events, including strokes, nonfatal blood clots, and fatalities, says Scott. (The company says it doesn't keep a tally, but forwards all such reports to the fda.) More than 100 pending lawsuits attribute injuries to the device.
Hans Rekers, Schering-Plough's deputy chief medical officer for Europe, says the company did study thousands of women using the ring, complied with the fda's research requirements, and dutifully reported "thrombotic events" during clinical trials. That research, he says, showed "no indication that [NuvaRing] would be better, no indication that it would be worse," than pills now on the market.
But in a case involving a different product, the drugmaker Johnson & Johnson discovered that changing the manner of delivery can radically alter a hormone's effects. From 2002 through 2006, at least 40 women died using its weekly Ortho Evra patch, most from blood clots. In 2006, the FDA ordered J&J to mark its packaging with a "black box" warning, which seriously hurt sales.
The company had previously claimed, as Schering-Plough now does, that its product delivered a more constant, low dose of hormones, causing fewer side effects. But it turned out patch users were getting 60 percent more estrogen than women taking birth control pills.
Back to NuvaRing: While the company never studied its risks vis-à-vis other contraceptives, two research teams have done so in recent years, measuring blood factors linked to clot formation. A group from Oregon Health & Science University—funded in part by Organon—concluded that switching from the pill to the ring seems to reduce the likelihood of clotting.
The other group, which included Frits Rosendaal, an epidemiologist at Leiden University in the Netherlands, tested women rotating between the ring, the patch, and second-generation pills, and reached the opposite conclusion: that NuvaRing appears to be riskier than second-generation pills.
As of May 2011, the FDA has received almost 1,000 reports of possible NuvaRing-related blood clots. Currently, more than 700 women are suing the drug company that manufactures NuvaRing, Merck, for downplaying the serious risks of the birth control.
NuvaRing has been associated with other adverse side effects such as:
- Heart Attack
- Deep Vein Thrombosis
- Myocardial Infarction
- Cerebrovascular Accidents
- Pulmonary Embolism
The potential problem with NuvaRing stems from the fact that it delivers a constant, uncontrolled stream of hormones into the body. As a result, NuvaRing users can end up with higher concentrations of estrogen than with previous birth control pills. Excessive levels of estrogen can increase the probability of a blood clot, which may manifest itself in multiple ways including deep vein thrombosis (DVT), pulmonary embolism, and arterial thrombosis leading to heart attack and stroke.
DVT occurs when a blood clot originates in a deep vein of the body, typically the legs, while a pulmonary embolism involves a partial or entire entity of a blood clot lodging itself into blood vessels of the lungs. According to a study published by the U.S. Food & Drug Administration (FDA) in 2011, these risks are 56% more likely to occur in NuvaRing users in comparison to those who use traditional birth control pills.
NuvaRing is not the only new form of birth control to cause controversy. Bayer’s Yaz and Yasmin pills and Johnson & Johnson’s Orthro Evra contraceptive patch have also been under fire for similar reasons. Based on these allegations, it appears that NuvaRing and other recent forms of birth control present a greater risk than previous forms of contraceptives which are said to be just as effective.
Venous thrombosis in users of NuvaRing hormonal contraception: follow-up study, Denmark 2001-10
This study indicates that users of this form of contraception may have been at an increased risk of pulmonary embolism, stroke, heart attack and deep vein thrombosis (DVT). Levin Papantonio is evaluating injury and death claims claims related to the NuvaRing product. Our experience in both the Ortho Evra injury litigation and the Yaz litigation indicates that serious consideration needs to be given to potential NuvaRing claims.
BMJ 2012; 344 doi: 10.1136/bmj.e2990 (Published 10 May 2012)
Incidence of venous thrombosis in users of transdermal contraceptive patch and corresponding combined oral contraceptive (COC) with norgestimate, and rate ratio of venous thrombosis in users of patch versus users of combined oral contraceptives with norgestimate
With an incidence of 7.8 confirmed events per 10 000 exposure years, the vaginal ring conferred a 90% higher risk of venous thrombosis than did combined oral contraceptives containing levonorgestrel, bringing the risk to the same level as that of combined oral contraceptives with third and fourth generation progestogens, and compatible with the Food and Drug Administration study. Supporting our and the FDA results is the three and five times increase in sex hormone binding globulin in users of vaginal ring contraception compared with users of combined oral contraceptives containing levonorgestrel, and the activated protein C sensitivity ratio 3.75 times higher than with oral contraceptives, both considered as surrogate markers for the risk of venous thrombosis.
The modest non-significant 40% increased relative risk of venous thrombosis in women using subcutaneous implants is not surprising, as other types of progestogen only contraception do not confer an increased risk, and it is less than half the risk found in users of combined oral contraceptives containing levonorgestrel.
The low risk of venous thrombosis in users of the levonorgestrel intrauterine system has been shown in previous studies. In the present study this product actually significantly decreased the risk of venous thrombosis, suggesting that the influence of progestogen only contraception on risk of venous thrombosis may depend on dose.