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Executive Summary

Oral contraceptive labeling should delete the language on increased risk of mortality for healthy, non-smoking women 40 years of age or older, FDA's Fertility and Maternal Health Drugs Advisory Committee recommended at its Oct. 26 meeting. Summarizing the panel's conclusion, Committee Chairperson Barbara Hulka, MD, University of North Carolina, stated: "For healthy, non-smoking women, the upper age limit for OC [oral contraceptive] use should be removed." Hulka added: "Although cardiovascular risks might be increased with OC use in women over 40, many believe the benefits of OC use outweigh the possible risks." In considering "the benefits relative to risks associated with pregnancy and alternative surgical procedures" she noted, "overall, the risks and benefits of OCs in older women appear to be favorable to OC use." * Panel member Jennifer Niebyl, MD, University of Iowa, noted that "there may be some increased risk of using the pill after 40, but there are risks in not using it, including the risk of getting pregnant, the risk of sterilization" and the "risk of abortion." In presenting his rationale for eliminating the upper age limit, Daniel Mishell, Jr., MD, University of Southern California School of Medicine, said that the statement "leads to de facto discontinuation of use of oral contraceptives by physicians when a women reaches age 40." As result, he added, these women have limited contraception options such as barrier methods, which have high failure rates. "The incidence of elective pregnancy termination . . . is highest in this age group than any other age group of women . . . except young girls under the age of 15," Mishell pointed out. The idea to drop the upper age limit for oral contraceptive use stemmed from disagreement with the current labeling from OB/GYN practitioners, who felt that availability of low-dose oral contraceptives had reduced the relative risks for older women. FDA Fertility and Maternal Health Drugs Group, Medical Officer, Ridgely Bennett, MD, noted that the upper age limit statement, contained in a section of the labeling entitled "Estimates Of Mortality From Contraceptive Use," is based on a paper published in 1983. The statement in Ortho-Novum labeling reads: "The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth. However, smokers 35 and older and non-smokers 40 and older who use oral contraceptives have a significant increase in mortality higher than those using other methods of birth control." Committee members noted that their decision to recommend deleting the upper age limit is based on a hypothesis rather than hard data. "This recommendation is based on very little new data," Hulka said. "It's primarily based on informed opinion; it's also based on the inference that lower dose pills inherently carry lower risks." Panel members pointed out that there is a need for studies of oral contraceptive use in older women. Hulka said "that in making this recommended change it will be important to incorporate some way to study and evaluate the effect of this recommendation." The need for studies was addressed by FDA Epidemiology Branch Chief Bruce Stadel, MD: "I think that ongoing research in this area is essential. I would emphasize . . . further case control studies targeted to the major diseases, particularly myocardial infarction -- which has weighed so heavily in the decisionmaking in the past, must be designed so that" one gets an estimation of attributable risk. A representative from the National Women's Health Network, Adriane Fugh-Berman, contended that it would be inappropriate to eliminate or raise the upper age limit. "The committee should consider that if the recommended age limit is removed, we may see an increase in thromboembolic events, breast cancer and surgical deaths," she said. Considerations include "increased health risks in this group, decreased fertility in this group, the availability of effective alternative contraception, and unknown ramifications of long-term hormonal manipulation," Fugh-Berman added.

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