The Real Danger of NuvaRing

Article taken from March/April Newsletter 2014

If you’ve read recent media coverage about NuvaRing, you could be excused for thinking that that the contraceptive ring is deadly and should be yanked off the market immediately. But hold on.

A Vanity Fair article from early 2014 focused heavily on lawsuits alleging harms from the device — especially from dangerous blood clots.What that and other sensational articles fail to do, however, is put the potential risk from NuvaRing in the context of either normal risks or risks from other hormonal birth control options. Nor do they discuss the real magnitude of risk of any of these options. Blogger Jessica Grose calls these “birth control scare stories” and notes the media’s love affair with this type of content.2

NuvaRing, a hormonal birth control, is inserted into the vagina. It contains a combination of estrogen and etonogestrel, a form of progestin that’s different from what’s in the most common low-dose combined birth control pills. All hormonal birth control with estrogen carries some risk of blood clots, which are technically called venous thromboembolisms (VTE), and can be fatal.3 But, the risks of VTE from the most common low-dose combined oral contraceptives are quite small.

We’ll talk about NuvaRing’s increased risks below, but first, some background. The latest Food and Drug Administration (FDA) safety announcement estimates that, for every 10,000 women taking birth control pills, between 3 and 9 cases of blood clots may occur per year.4  It’s important to note that blood clots don’t occur just among women taking birth control: there is a higher risk of experiencing blood clots during pregnancy (5 to 20 cases annually per 10,000 women); women who aren’t pregnant and don’t take birth control pills have between 1 to 5 blood clots annually, per 10,000 women.

Newer types of birth control pills that contain the progestin drospirenone (e.g., Yasmin, Yaz) are thought to cause a greater risk for blood clots than the “normal” birth control pills the estimates are based on.5 The newer pills have come under scrutiny in Europe and the United States recently.6 Some women’s health advocates — including the NWHN and Our Bodies Ourselves — have called on the FDA to take drospirenone-containing pills off the market, since they pose a greater clot risk without offering any clear benefits over older types of pills.

The factors a woman considers when weighing the risks and benefits of NuvaRing or any other contraceptive method — whether it contains hormones or not — vary from woman to woman. The pill works for some women, while others appreciate the convenience and reduced chance of missing a dose provided by alternatives like NuvaRing and the patch. For some, that’s worth the slightly elevated risk of experiencing blood clots.

Part of the problem in determining what’s “best” for you is the lack of clarity about the increased risk that may come from using NuvaRing. Indeed, different studies have yielded different results: A British Medical Journal (BMJ) study found about a 90 percent increased risk;7 an FDA drug safety paper reports a 56 percent increased risk;8 other studies have reported “similar” rates of VTE between NuvaRing and regular oral contraceptives.9

Let’s consider the actual numbers, looking at the BMJ study, which has the most alarming findings. The 90 percent increased risk of clots from NuvaRing would result in 7.8 incidents of VTE per 10,000 exposure years. That means, if 1,000 women used NuvaRing for 10 years, there would be about 8 incidents of VTE among them, vs. 3 – 9 for pill users.10 The fact is, while different methods of hormonal birth control carry different levels of risk, in general, hormonal birth control is very safe for most women. What is of greater concern, however, is that women aren’t given this information to help their decision-making.

There have also been allegations that Organon — the company that made NuvaRing, which Merck now owns — maneuvered to keep clot risk information off the product label during the FDA approval process.11 The NuvaRing label lacks the “black box warning” which is printed on the birth control patch label and notes the product has a higher clot risk than contraceptive pills.12   NuvaRing’s product label simply notes that smokers may have “serious cardiovascular events.”13 The NuvaRing website includes some information comparing the risk to combined oral contraceptives, but we believe this important safety information should also be on the FDA-approved label in the same manner as it is on the patch’s label.

Cindy Pearson, NWHN’s Executive Director, and a strong advocate for close review of drug safety, has responded to the concerns, saying:

The most heartbreaking part of the Vanity Fair article are the accounts of women who never knew that the contraceptive ring 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.14

Agreed. While the risk to an individual woman may be low with any of these birth control methods, womenmust be informed that some options — including the ring, the patch, and the drospirenone-containing pills — may be more risky than older combined oral contraceptive pills. And, health care providers need to stay on top of the evidence so that they can actively discuss the benefits and risks of all options with the women they see. All women should have the information they need to make the best choices for their own health.

A version of this article originally appeared at Our Bodies Ourselves:http://www.ourbodiesourblog.org/blog/2014/01/the-real-danger-of-the-nuvaring.

 

This article was written by: Rachel R. Walden

Rachel R. Walden, MLIS is a medical librarian and blogger for Women’s Health News and Our Bodies Our Blog.

 


 

REFERENCES

1. Brenner M, “Danger in the Ring,” Vanity Fair 2014, Available online at:http://www.vanityfair.com/politics/2014/01/nuvaring-lethal-contraceptive…

2. Grose J, “Do Not Fear Your Birth Control,” Slate, January 22, 2014. Available online at http://www.slate.com/blogs/xx_factor/2014/01/22/magazine_stories_about_e….

3. Walden R, “Hormonal Contraception and Heart Risks,” Our Bodies, Ourselves website, June 22, 2012. Available online at: http://www.ourbodiesourblog.org/blog/2012/06/hormonal-contraception-and-heart-risks.

4. Food and Drug Administration (FDA), “Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone,” Silver Spring: FDA, February 14, 2014. Available online at: http://www.fda.gov/drugs/drugsafety/ucm299305.htm

5. Our Bodies, Ourselves website, “Concerns About the FDA’s Review of the Safety of Yasmin and Similar Contraceptives,” posted on March 24, 2012 at:  http://www.ourbodiesourblog.org/blog/2012/03/concerns-about-the-fdas-review-of-the-safety-of-yasmin-and-similar-contraceptives

6. Our Bodies, Ourselves website, “Europe Takes on Review of Birth Control Pills Containing Drospirenone,” posted on March 5, 2013 at http://www.ourbodiesourblog.org/blog/2013/03/europe-takes-on-review-of-birth-control-pills-containing-drospirenone

7. Lidegaard Ø, Hougaard Nielsen L, Skovlund CW et al., “Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10,” BMJ 2012;344:e2990. Available online at:http://www.bmj.com/content/344/bmj.e2990

8. Combined Hormonal Contraceptives (CHCs) and the

Risk of Cardiovascular Disease Endpoints

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf

9. Cardiovascular Risk Associated With the Use of an Etonogestrel-Containing Vaginal Ring.http://journals.lww.com/greenjournal/Abstract/2013/10000/Cardiovascular_…

10. Food and Drug Administration (FDA), Combined Hormonal Contraceptives (CHCs) and the

Risk of Cardiovascular Disease Endpoints, Silver Spring: FDA, no date. Available online athttp://www.fda.gov/Drugs/DrugSafety/ucm299305.htm. (i.e., 1,000 women x 10 years = 10,000 exposure years).

11. Siddiqui S, “Side Effects May Include Death: The Story Of The Biggest Advance In Birth Control Since The Pill,” Huffington Post, posted on December 18, 2013 at:

http://www.huffingtonpost.com/2013/12/18/nuvaring-blood-clots_n_4461429.html

12. Lidegaard Ø, Hougaard Nielsen L, Skovlund CW et al., “Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10,” BMJ 2012;344:e2990. Available online at:http://www.bmj.com/content/344/bmj.e2990

13. Food and Drug Administration (FDA), “NuvaRing label,” Available online at:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf

14. Pearson C, “Women deserve full information about the birth control ring, National Women’s Health Network blog, posted on December 13, 2013. Available online at: http://nwhn.org/2013/12/13/women-deserve-full-information-about-birth-co…