Safety of oral contraceptives.

Abstract

The safety of oral contraceptives is discussed. Committees established to study the question of the safety of oral contraceptives concluded that there were no scientific data to support the relation of the oral contraceptives to the various serious adverse reaction examined. They stated that objective examination of the available data neither proved nor disproved the safety of long-term administration of the gestogens. The data derived from mortality statistics are not adequate to confirm or refute the role of oral contraceptives in thromboembolic disease. They do suggest that if oral contraceptives act as a cause they do so very infrequently relative to the number of users. Proof or disproof of the relation between the oral contraceptives and human cancer does not exist. Data regarding effects on carbohydrate metabolism in experimental animals and in women are contradictory. Many women on oral contraceptives show abnormalities of some liver function tests especially the BSP and transaminase. The advisory committee made recommendations to the Commissioner of The Food and Drug Administration; these included a large case-control retrospective study of thromboembolism and a continuation of several long-term prospective studies a tightening of record-keeping procedures increased feedback to industry and more communication with industry simplification to procedures and uniformity of labeling and abolition of time limits for administration.