Taken from the May/June 2012 issue of The Women's Health Activist Newsletter.
With contraception being used as a political football, it’s harder than ever to address questions about the safety of specific contraceptive methods. With right-wing politicians poised to exploit any opening, women’s health advocates are understandably hesitant to air concerns that might be used as a weapon against family planning programs that serve critical reproductive health needs. How can a responsible feminist ask whether the contraceptive shot is safe when Rush Limbaugh is raving on national radio about how women who stand up for the right to use contraception are sluts?
But, advocates who want to make sure that women can make the best decisions for their families and their health about when and whether to have children need to be able to acknowledge the facts about contraceptive options. The National Women’s Health Network advocates for all women to have access to a full range of safe and effective contraceptives so that every woman can find the option that best meets her needs. We believe different methods are right for different women at different times in their lives. And, that means we need to be able to take a clear-eyed look at every contraceptive method available.
It also means that, when safety questions come up about a specific method, we need to look at the evidence and ask hard questions about whether the method contributes positively to women’s reproductive health. Yet, we need to start by remembering how much has been accomplished in this field to protect and promote women’s health: thanks in no small part to the work of the Network’s founders, contraceptives available in the U.S. are very safe for most women. We’re proud of the role the Network has played in working with the Food and Drug Administration (FDA) to ensure that women know about the risks associated with contraceptives and to persuade manufacturers to develop safer options so that women have better contraceptives to choose among.
With that general safety assurance as the backdrop, let’s take an honest look at two recent contraceptive safety questions.
Contraceptive shots and risk for HIV infection
Last fall, a study conducted in seven sub-Saharan African countries raised questions about whether using progesterone contraceptive injections (like Depo Provera) might increase a woman’s risk of transmitting and acquiring HIV infection.1 HIV-negative women in the study were twice as likely to contract HIV from an infected partner if they used progesterone contraceptive shots; HIV-positive women who were using the shots were twice as likely to transmit HIV to an uninfected partner.
A few things about the research make it hard to know what these findings mean for other women. The study wasn’t designed to evaluate the effect of contraceptive use on risk of HIV infection, making conclusions about that connection less convincing. Also, researchers didn’t track whether people using hormonal contraceptives had sex more often, which could lead to increased HIV exposure. Finally, participants’ contraceptive use was self-reported, and the self-reports showed there was a lot of switching between methods and generally low use of hormonal contraceptives.
Still, the increased risks of both HIV acquisition and transmission were significant even when researchers adjusted for things like age and condom use. And this wasn’t the first research to identify the possibility that progesterone contraceptive shots might increase HIV infection risk. These are not results that can be dismissed or ignored — and the international family planning community did not ignore them. In January, the World Health Organization (WHO) published findings from experts who reviewed existing research on the connection between hormonal contraceptive use and HIV acquisition, transmission, and progression.2
The experts said there wasn’t enough evidence to determine whether using progesterone contraceptive shots causes an increase in HIV infection in women, but they couldn’t rule out the possibility that it does. They recommended that the WHO’s guidelines not restrict women at high risk of HIV infection or women living with HIV from using progesterone contraceptive shots. But, they advised adding a statement to WHO’s materials to reflect the fact that “some studies suggest that women using progesterone-only injectable contraception may be at increased risk of HIV acquisition, [while] other studies do not show this association.” The findings also stress the importance of promoting consistent use of male and female condoms and urge health care providers to incorporate that message in counseling women who use progesterone contraceptive shots.
The Network agrees with these conclusions. When there’s uncertainty about a possible serious risk, we support telling women what is known so they can make informed decisions. In this case, that means sharing full information about prevention options for protecting against both unintended pregnancy and HIV. We also recommend that women using progesterone contraceptive shots be advised to consider getting tested for HIV more often than they might otherwise.
Furthermore, the WHO conclusions point to the need for more research to confirm, or refute, the study’s findings. And additional research is needed on the link between HIV risk and other kinds of hormonal contraception, including pills, patches, and rings. Finally, we encourage the FDA to update the label for progesterone contraceptive shots to include a statement like the one recommended for the WHO.
Drospirenone pills – how are these pills different from all the others?
In 2011, the FDA’s Reproductive Health Drugs Advisory Committee met to discuss safety questions about oral contraceptives that contain the progestin drospirenone. The brand names for these pills are Yasmin, Yaz, Beyaz, Safyral, and there are several generic versions, as well. These pills deliver a combination of estrogen and progestin, like many other contraceptive pills; drospirenone is just a newer generation of progestin than the one used in other combination pills. What’s different about them is that women taking drospirenone pills appear to be more likely to get blood clots than women using other oral contraceptives.
We’ve known for many years that combined hormonal contraceptives cause a small increase in risk of blood clots. The FDA label for these products informs women about that small risk, and many women choose to use them anyway because they also offer benefits that women value: a convenient and effective way to space births and prevent unintended pregnancy. The FDA Committee was asking whether the evidence of blood clot risk for drospirenone pills warrants treating those pills any differently.
The Network reviewed data from well-designed studies comparing health outcomes for women who took pills containing different combinations of hormones.3 We concluded there is strong evidence showing the risk of blood clots is greater for drospirenone pills than for pills containing older kinds of progestin. Specifically, women taking drospirenone pills are 74 percent more likely to develop a blood clot than women taking other pills. The risk is still very small, but contraceptive pills are used by tens of millions of healthy women who could potentially be exposed to this increased risk.
Market analyses show that drospirenone pills are some of the most frequently-prescribed birth control pills on the market, although they are relatively new. The quick establishment of this substantial market share has been driven by aggressive consumer advertising and promotional campaigns to clinicians. Bayer, which manufactures the leading brand-name drospirenone pills, was reprimanded by the FDA for its misleading ads that overstated the pills’ benefits and downplayed the health risks.4
The ads are not Bayer’s only deceptive action. Lawsuits against the company revealed that it had concealed from the FDA an internal analysis that showed a concern about increased risk of blood clots associated with Yasmin. Bayer also delayed reporting blood clots to the FDA so Yasmin would appear to have an adverse event rate similar to other oral contraceptives, when the true rate was substantially higher. Former FDA Commissioner David Kessler stated publicly that Bayer “obscured the potential risks associated with Yasmin,” leading the FDA to approve a product he believes would otherwise have been subjected to further investigation before approval.5
The question for a woman is, what should she weigh these risks against? As some have pointed out, the blood clot risks of pregnancy are greater than those of drospirenone pills. Is that the right basis of comparison? The Network does not believe it is. There are other, safer, ways women can avoid the risks of pregnancy – including contraceptive pills that don’t contain drospirenone. Drospirenone pills don’t provide a unique benefit over other available contraceptive pills. We’re also concerned that most women using drospirenone pills are unaware that other contraceptive pills are safer.
We believe that women who are looking for contraceptive options to help them postpone or prevent pregnancy should not be unnecessarily exposed to a higher risk of blood clots when there are safer alternatives with the same benefits available. That’s why we recommended that the FDA take drospirenone pills off the market. As of this writing, the FDA has not followed our recommendation. So for now, we urge women looking for a safe, effective contraceptive option to be wary of drospirenone pills.
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1. Heffron R, Donnell D, Rees H, et al., “Use of hormonal contraceptives and risk of HIV-1 transmission: a prospective cohort study”, Lancet Infectious Diseases 2012;12(1):19-26. Epub 2011 Oct 3.
2. World Health Organization (WHO), Hormonal Contraception and HIV: Technical Statement, Geneva: WHO, January 2012. Available online at.http://www.who.int/reproductivehealth/topics/family_planning/Hormonal_contraception_and_HIV.pdf.
3. Seeger JD, Loughlin J, Eng PM, et al., “Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives”, Obstet Gynecol 2007; 110(3):587-93. Dinger JC, Heinemann LA, Kühl-Habich D, “The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation”, Contraception 2007; 75:344-54. Lidegaard Ø, Løkkegaard E, Svendsen AL, et al., “Hormonal contraception and risk of venous thromboembolism: national follow-up study”, BMJ 2009; 339:b2890. Van Hylckama V, Helmerhorst FM, Vandenbroucke JP, et al., “The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study”, BMJ 2009; 339:b2921. Parkin L, Sharples K, Hernandez RK, et al., “Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database”, BMJ 2011; 342:d2139. Jick SS, Hernandez RK, “Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data”, BMJ 2011; 342:d2151.
4. Food and Drug Administration, “Warning Letter Re NOA # 21-676, 21 ~873, 22~045 YAZ(f (drospirenone and ethinyl estradiol) Tablets; MACMIS 10# 16473”, Silver Spring MD: FDA, October 3, 2008. Available online at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati....
5. Silverman E, “Former FDA Commish: Bayer Hid Yasmin Data”, Pharamalot, December 6, 2011. Available online at: http://www.pharmalot.com/2011/12/former-fda-commish-bayer-hid-yasmin-data/