Standardized instructions urged for OCs

FDA has developed standardized, simplified instructions for all brands of combined estrogen and progestogen oral contraceptives (OCs) to help reduce unplanned pregnancies. FDA asked manufacturers in April to incorporate these changes into patient package inserts as soon as possible. Since current instructions vary significantly from brand to brand, problems can occur when women switch brands and compare instructions. If they become confused, women may either take the pills incorrectly or stop altogether, risking an unwanted pregnancy. In addition to reducing patients' confusion about correct use, the new recommended instructions reflect current research on the effective use of OCs. An important change concerns when women should start taking pills. The new instructions provide only 2 options (current instructions provide more): either start on day 1 of the next normal menstrual cycle ("Day 1 Start") or on the 1st Sunday after the next cycle begins ("Sunday Start"). Although the "Sunday Start" option is popular, the "Day 1 Start" has been shown to be more effective since back-up contraceptive methods are not required for the 1st week, as they are for the "Sunday Start." Other changes in the patient package insert simplify and clarify the instructions when different numbers of pills are missed. Any patient who is unsure about what to do when pills are missed is told to use a back-up method of birth control and to keep taking pills with hormones until she van consult with a health professional. The new labeling also advises women to consult a health professional regarding other methods of contraception if taking a daily pill is a problem. These new directions for patients are for combination pills and do not apply to progestin-only OCs. FDA is still developing new labeling for them. FDA's Fertility and Maternal Health Advisory Committee recommended on FEb. 8, 1991, that the agency ask manufacturers of OCs to make these changes in the patient package insert.