Over-the-counter access to combined oral contraceptives for individuals with hypertension: an expert review
- PMID: 41146983
- PMCID: PMC12554057
- DOI: 10.1016/j.ajpc.2025.101328
Over-the-counter access to combined oral contraceptives for individuals with hypertension: an expert review
Abstract
Efforts are underway to move a combined oral contraceptive over the counter in the United States. However, hypertension is an important contraindication and questions exist regarding how users should screen for it in an over-the-counter setting. An expert panel convened in April 2022 to review the literature related to hypertension and an over-the-counter switch for combined oral contraceptives and vote on a set of blood pressure screening recommendations for future over-the-counter combined oral contraceptives. Research indicates that people can accurately self-screen for contraindications to combined oral contraceptives using simple checklists, and the absolute risk of adverse events is low among people with hypertension who use combined oral contraceptives and must be balanced against substantially higher risks of pregnancy as well as benefits of increased contraceptive access. Based on these data, the panel concluded that 1) individuals who have not had their blood pressure checked in the last year or do not know their blood pressure should be advised in product labeling to get it checked prior to purchase; 2) blood pressure documentation should not be required to purchase over-the-counter combined oral contraceptives, provided over-the-counter switch behavioral studies demonstrate individuals can correctly self-screen for use; and 3) blood pressure screening should be made more accessible and affordable. Over-the-counter combined oral contraceptives may increase access to the most commonly used reversible contraceptive method. They may also provide an opportunity for enhanced education and awareness of hypertension and preventive cardiovascular screenings among people of reproductive age, particularly young people and people of color.
© 2025 The Author(s).
Conflict of interest statement
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kate Grindlay and Katherine Key reports financial support was provided by Collaborative for Gender + Reproductive Equity. Kate Grindlay and Katherine Key reports financial support was provided by 10.13039/100000008David and Lucile Packard Foundation. Martha Gulati reports financial support was provided by 10.13039/100000050National Heart Lung and Blood Institute. Martha Gulati reports financial support was provided by 10.13039/100000097National Center for Research Resources. Martha Gulati reports financial support was provided by 10.13039/100006108National Center for Advancing Translational Sciences. Martha Gulati reports financial support was provided by 10.13039/100000005Department of Defense. Martha Gulati reports financial support was provided by 10.13039/100001796Gustavus and Louis Pfeiffer Research Foundation. Martha Gulati reports financial support was provided by Women’s Guild of Cedars Sinai Medical Center. Martha Gulati reports financial support was provided by The Ladies Hospital Aid Society of Western Pennsylvania. Martha Gulati reports financial support was provided by 10.13039/100013015Cedars-Sinai Medical Center. Martha Gulati reports financial support was provided by 10.13039/100009821Society for Women’s Health Research. Martha Gulati reports financial support was provided by 10.13039/100017007Adelson Family Foundation. Martha Gulati reports financial support was provided by Robert A. Winn Diversity in Clinical Trials Career Development Award. Martha Gulati reports financial support was provided by Anita Dann Friedman Endowment in Women’s Cardiovascular Medicine and Research. KG and KK are affiliated with Ibis Reproductive Health, which has a partnership with HRA Pharma in which Ibis provided financial support for some of the research that was part of an over-the-counter switch application to the US FDA for a progestin-only pill. Ibis receives no monetary compensation nor ownership of any rights to the product. Ibis raised the funding for this partnership from a private foundation and selected HRA Pharma as its partner through an open process overseen by the Oral Contraceptives Over-the-Counter Working Group steering committee in an effort to incentivize a pharmaceutical company to complete the work to make a birth control pill available over the counter. DG reported receiving grants from Ibis Reproductive Health outside the submitted work and being a member of the Free the Pill Coalition steering committee. MG reported consulting with Novartis, Esperion, and Medtronic Inc, and serves on a DSMB for an investigational product for Merck, all unrelated to this topic. MK reported consulting with HRA Pharma on its over-the-counter switch application to the US FDA for a progestin-only pill. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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