The Pill: A New Warning

The oral contraceptive pill is under indictment once more. This time it is accused of increasing the risk of heart attacks among women over 30, and especially among those over 40. The U.S. Food and Drug Administration has just sent a warning bulletin to 600,000 medical professionals, suggesting that they advise Pill-taking patients over 40 to switch to some other contraceptive.

It has been known since the late 1960s that for some women, the Pill enhances the dangers of blood clots forming in the legs (thrombophlebitis) and traveling to the lungs (pulmonary embolism), with possibly fatal results. The Pill may also cause strokes. That indictment originated with two teams of Britain's most eminent epidemiologists, now at the University of Oxford. The danger has since been widely confirmed, although the risk that any particular woman will suffer any of these severe effects is statistically small. The latest indictment is based on two later studies by essentially the same research teams.

New Labeling. Two months after both reports were published in a May issue of the British Medical Journal, the FDA's advisory committee on obstetrics and gynecology (ten M.D.s, one Ph.D.) met and concluded that a warning was justified. Among British--as well as American--women aged 30 to 39 who do not use the Pill, the incidence of nonfatal heart attacks is only 2.1 per 100,000. But for those on the Pill, the rate rises to 5.6 per 100,000. For women aged 40 to 44, the rates for the two groups are 9.9 and 56.9 respectively. Similar increases are found in the rate of fatal heart attacks: ages 30-39, only 1.9 per 100,000 nonusers against 5.4 per 100,000 among users; in the 40-44 group, 11.7 for nonusers and 54.7 for users. The best available figures indicate that 18% of Pill users are in the 30-39 age bracket, and only 6% are over 40.

The FDA announced that it intends to require the inclusion of an appropriate warning in the labeling of oral contraceptives. But this "labeling" does not refer to the little sticker that the pharmacist puts on the bottle or box of pills. It refers to the fine-print technical information that drug companies supply only to pharmacists, doctors and to the publisher of the widely used book, Physicians' Desk Reference. Thus it will still be up to the conscientious doctor to convey the warning to his patients.

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