Back to Annual Meeting Page		American Public Health Association 133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA

Abstract #116038

Kate Schaffer, MSc, Ibis Reproductive Health, 2 Brattle Square, Cambridge, MA 02138, 617-349-0024, kschaffer@ibisreproductivehealth.org, Tara Shochet, MPH, Population Studies Center, University of Michigan, 426 Thompson Street, Ann Arbor, MI 48106, and Daniel Grossman, MD, FACOG, Reproductive Health Program, Population Council, Panzacola 62-102, Col. Villa Coyoacán, Mexico, Mexico.

Oral contraceptives (OCs) are an important, routine aspect of health care for American women. According to the most recent National Survey of Family Growth, 19% of American women rely on OCs for their birth control, and over 82% of women have used OCs at some point in their lives. Nevertheless, evidence indicates that many women overestimate the health risks associated with OCs and that misinformation and fear may dissuade even greater numbers of women from taking advantage of the contraceptive and non-contraceptive benefits of OCs. The FDA and the World Health Organization (WHO) are the two main normative bodies responsible for setting labeling and use guidelines for contraceptives. Therefore, their recommendations and warnings should be based upon the most current research available. We conducted a comprehensive review of the literature on the safety of OCs and compared the contraindications and warnings listed in the current product labeling, the most recent Guidance for Industry circulated by FDA, and the WHO's Medical Eligibility Criteria to determine if there was consistency among the guidance documents and whether their recommendations reflect the most up-to-date research. We found important differences between the FDA labeling and the WHO Medical Eligibility Criteria and determined that current OC labeling does not reflect the most up-to-date research available on their safety. Furthermore, the labeling is often vague and uses inexact terminology for some contraindications. The inclusion of outdated or unsubstantiated information may deter health care providers from prescribing OCs and it may discourage women from using OCs.

Learning Objectives: At the conclusion of the session, participants will

• Understand the evidence for the contraindications and health risks associated with oral contraceptives and how the product labeling does or does not reflect this evidence.
• Describe how the FDA and WHO guidelines differ regarding contraindications to oral contraceptive use.
• Identify evidence-based improvements in the oral contraceptive labeling and needs for future research to address unanswered questions regarding contraindications to oral contraceptive use.

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.