If you read the recent Vanity Fair article about NuvaRing contraception, “Danger in the Ring,” you could be excused for coming away with the conclusion that NuvaRing is deadly and should be yanked off the market immediately.
But hold on.
NuvaRing, a hormonal birth control that is inserted into the vagina, contains estrogen and etonogestrel, a form of progestin that’s different from what’s in the most common low-dose combined birth control pills. As the Vanity Fair article describes, it is also the subject of ongoing lawsuits about dangerous blood clots.
Marie Brenner’s article focuses heavily those lawsuits alleging harms from the device. What it doesn’t do is put the risk of harms from NuvaRing in the context of other hormonal birth control options, or discuss real magnitude of risk of any of these options.
All hormonal birth control with estrogen carries some risk of blood clots. These are referred to as venous thromboembolism, or VTE, and can be fatal. The risks of the most common combined oral contraceptives are quite small.
The latest FDA safety announcement (2012) estimates that for every 10,000 women taking birth control pills over the course of one year, between three and nine cases of blood clots may occur. In fact, the risks are thought to be higher during pregnancy (five to 20 cases per year for every 10,000 women), and much higher right after birth. By comparison, among non-pregnant women who do not take birth control pills, the number of cases per year ranges from one to five.
Some types of birth control, such as the newer types of pills (like Yasmin and Yaz) containing the progestin drospirenone, are thought to cause a greater risk. These pills have come under more scrutiny in Europe and the United States, with Europe taking a more active role in reviewing the risks. Some women’s health advocates, including Our Bodies Ourselves, have questioned allowing these newer pills to remain on the market because they pose a greater clot risk without offering any major benefits over older types of pills.
The factors to consider when weighing the risks and benefits of NuvaRing or other non-pill alternatives may be different, however, because non-pill alternatives offer more convenience and less chance of missing a dose.
Part of the problem in determining what’s “best” for any individual is the lack of clarity surrounding the increased risk that comes with using NuvaRing. Indeed, different studies have yielded different results: A BMJ study included in the Vanity Fair article found about a 90 percent increase in risk; a FDA paper reports a 56 percent increased risk; other studies have reported “similar” rates of venous thromboembolism between the ring and the regular oral contraceptives.
Looking at the BMJ study, which seems most alarming, lets consider the actual numbers. The researchers explain a 90 percent increased risk would result in 7.8 incidents of VTE per 10,000 exposure years. That means, for example, if 1,000 women each used NuvaRing for 10 years, there would be about 8 incidents of VTE among them in that decade (1,000 women x 10 years = 10,000 exposure years).
So, while different methods of hormonal birth control carry different levels of risk, in general hormonal birth control is very safe for most women. Of great concern, however, is that women aren’t given this information to help in their decision-making.
A recent article in Huffington Post describes the FDA approval process for NuvaRing and alleges that Organon — the company that made NuvaRing, which pharmaceutical giant Merck now owns — maneuvered to keep clot risk information off the product label. To date, the NuvaRing label does not feature the same “black box warning” that the birth control patch carries, which notes a higher risk than the pill. Instead, the NuvaRing product label simply notes that smokers who use the ring may have “serious cardiovascular events.” The NuvaRing website does include some information on comparing the risk to combined oral contraceptives, but the FDA-approved label does not make this as clear by not including it in the black box warning that carries the most important safety information.
Cindy Pearson, executive director of the National Women’s Health Network, and a strong advocate for close review of drug safety, has responded to the concerns:
The most heartbreaking part of the Vanity Fair article are the accounts of women who never knew that the contraceptive ring was delivered a higher dose of hormones and is slightly more risky than pills. No clinician should offer women these products without fully disclosing the risks, and encouraging women to try alternative, safer forms of contraception if they haven’t already done so.
Agreed. While the risk to an individual woman may be low with any of these birth control methods, women must be informed that newer options — including the ring, the patch, and the newer pills — may be more risky than older-style combined oral contraceptives.
In addition, health care providers need to stay on top of the evidence, and should make a point of discussing the benefits and the risks. All women should have the information they need to make good choices for their own health.