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Special report: the truth about condoms. Restrictive label could impede plastic condom sales.

You walk into a drugstore to buy a package of plastic condoms. You happen to notice the label says that no one's sure how well they protect you from pregnancy or sexually transmitted diseases (STDs) like AIDS. Then, the label indirectly points you in the direction of latex condoms. What would you do? Some observers familiar with the condom industry speculate that the restrictive labeling carried on each package of the new plastic condoms for men will not interfere with consumers' purchasing decisions. Other predict an instant replay of the situation faced by makers of the polyurethane Reality female condom: A lack of data on pregnancy rates and STD rates resulted in a label touting latex as a superior product, which in turn caused an onslaught of negative press about the first plastic condom. The US Food and Drug Administration, finding itself in a similar position with approving plastic condoms for men, recently released interim labeling to be followed by all manufacturers who want to sell the new male condoms. Essentially, the manufacturers must point out on the front of the condom box that the product is "for latex-sensitive condom users," and on the back of the box must tell a potential buyer that risks for pregnancy and STDs are not known for the product. Upon reading this disclaimer, the consumer then reads that "latex condoms for men, if used correctly with every act of vaginal intercourse, are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection)."

Condoms↗

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.

Americas↗