Healthy Skepticism Library item: 66

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

National Women's Health Network
FDA Approves New Version of the Pill
2003 Sep 22
http://www.womenshealthnetwork.org.

Full text:

The U.S. Food and Drug Administration (FDA) has approved a new version of the oral contraceptive pill B one that changes a woman’s menstrual cycle to produce only four periods each year. The new pill will be marketed under the brand name Seasonale. It is the first product approved for this combination of contraception and menstrual suppression.

This update gives you a brief overview of the National Women’s Health Network’s perspective on this new contraceptive option. If you’re interested in getting more details, you can read the full statement posted on our website at http://www.womenshealthnetwork.org.

Facts about Seasonale
Seasonale is chemically identical to traditional oral contraceptive pills (OCs). The difference lies in the way a woman takes these pills. The traditional OC is taken for 21 days, followed by 7 days of placebo pills. Seasonale is taken for 84 days consecutively, followed by 7 days of placebo pills. In both cases, while the woman is taking the placebo pills, she gets her period.

Seasonale was tested in a randomized clinical trial of 1,400 women between the ages of 18-40, comparing it to a traditional OC. Its effectiveness in preventing pregnancy and its safety profile were very similar to the traditional pill. (The small risks of stroke and blood clots associated with traditional oral contraceptives B increased in women who smoke B are also associated with Seasonale.)

Advantages for some women, concerns for others
For women who have pain or other discomfort with their periods, the option of menstrual suppression that Seasonale provides offers a health benefit by reducing the frequency of that experience. Additionally, some women might choose Seasonale because they see the reduced number of periods as a convenience. Other women prefer monthly menstruation because they rely on the monthly period as a signal that they are not pregnant or because they view it as a sign that their bodies are in a healthy rhythm. They will be less likely to choose or be satisfied with Seasonale.

The Network supports the availability of this option for women who want to suppress menstruation. We do, however, have some concerns about the way it is being discussed in the medical community and may be presented to women by health care providers.

If menstrual suppression is presented as the more natural or healthier option, as some physicians have been describing it, that may lead women who prefer the monthly cycle to worry about the health effects of their decision not to use hormones to control their periods. And if it’s sold by contrasting the experience of using Seasonale with a very negative presentation of menstruation, it may have a harmful effect on girls and women’s body image and relationship to their bodies, particularly with young teens who are just beginning to learn about menstruation and are forming a new understanding about the way their bodies work.

An accurate and balanced discussion of the option must avoid exaggerating the medical need or overstating the health benefits of Seasonale. Even before Seasonale received FDA approval, however, some in the medical community have already begun to talk about the alleged health benefits of menstrual suppression in ways that raise concerns. One gynecologist who conducted research on menstrual suppression told the Wall Street Journal “It’s having seven or 10 kids that is natural, explaining that menstrual suppression Agets women to a more natural state. While it is accurate to say that women menstruate more today than they have at other times, the implication that monthly menstruation is unnatural is clearly illogical.

And this argument that less frequent menstruation is more natural leads directly to unsupported theories that proponents of menstrual suppression have also been putting forward about possible health risks of monthly menstruation and ovulation. Some scientists have speculated that reducing the frequency of menstruation and ovulation might reduce the risk of breast, endometrial and ovarian cancers and even extend fertility, but these ideas have not been proven by scientific study. The association that has been identified in epidemiological studies between frequency of menstruation/ovulation and some reproductive cancers does not indicate that one causes the other.

Making Seasonale available will expand women’s contraceptive options and increase convenience for some. This advance should not be undermined, however, by over-promising and over-promoting the product or by stigmatizing menstruation.