Applause—and Reservations—for Newly Approved Version of the Pill

The U.S. Food and Drug Administration (FDA) has approved a new version of the oral contraceptive pill that changes a woman's bleeding pattern to produce only four "periods" each year. Marketed under the brand name Seasonale, the new pill is the first product approved for this combination of contraception and menstrual suppression.

Seasonale is chemically identical to traditional oral contraceptive pills (OCs) and differs only in the way a woman takes it. The traditional OC is taken for 21 days, followed by seven days of placebo pills. Seasonale is taken for 84 days consecutively, followed by seven days of placebo pills. In both cases, the woman gets her period while taking the placebos.

A randomized clinical trial of 1,400 women between the ages of 18 and 40 compared Seasonale to a traditional OC. The pills were very similar in their effectiveness in preventing pregnancy and their safety profile (both have a small risk of stroke and blood clots; the risk increases for women who smoke).

The Network supports the availability of this option for women who want to suppress menstruation, particularly those who have pain or other discomfort with their periods. We do, however, have some concerns about the way it is being discussed in the medical community and the way it may be presented to women.

Some physicians describe menstrual suppression as the more natural or healthier option. This argument may cause women who prefer a monthly cycle to doubt their decision not to use hormones to control their periods. Similarly, when medical providers contrast the experience of using Seasonale with a negative presentation of menstruation, the result may be harmful to girls' and women's body image and relationship with their bodies, particularly young teens who are forming a new understanding about the way their bodies work.

An accurate and balanced discussion must avoid exaggerating the medical need or overstating the health benefits of Seasonale. 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. Although epidemiological studies have identified an association between frequency of menstruation/ovulation and some reproductive cancers, there is no proof that one causes the other.

Making Seasonale available will expand women's contraceptive options and improve convenience and/or comfort for some. This advance should not be undermined, however, by overpromising the product or by stigmatizing menstruation. Read the Network's full statement on Seasonale on our website, www. Womenshealthnetwork.org.