Medicine: Dangerous Sequence?

Of the estimated 8 million to 10 million women in the U.S. who take the Pill, perhaps 10% use the kind known as sequentials. Unlike the monthly supply of 21 standard birth-control pills, all of which consist of a combination of estrogens and progestins, the sequential package contains two different types of pill. For the first two weeks of her menstrual cycle, the sequential user takes an estrogen-only tablet; for the next five or six days she takes combination estrogen-progestin pills. Sequentials are sometimes prescribed for younger women who have adverse reactions—upset stomach, acne or painful swelling of the breasts, for example—to combination pills. But Food and Drug Administration medical officers last week warned that there may be an even more serious side effect from sequentials: an increased risk of cancer of the womb.

That concern was triggered by a recent study at the University of Colorado School of Medicine, where Drs. Steven G. Silverberg and Edward L. Makowski analyzed 21 cases of women under 40 who had developed endometrial cancer, or cancer of the lining of the uterus. Of these cases, they found that eleven were taking sequential oral contraceptives. By contrast, the doctors saw no definite link between the disease and the use of combination pills. While the Denver sampling is small, it is statistically impressive; the fact that more than half the victims used sequential pills was, in the doctors’ words, “highly significant” and “a worrisome situation.”

Persuaded by the data, FDA officials last week met with makers of the sequential pills (Oracon, Ortho-Novum SQ and Norquen). Unless drug companies can show that the benefits of sequentials outweigh the risks for certain women, the FDA said, it will order the pills withdrawn from the market.