Kurt Kraetschmer*

MD, PhD, Austrian-American Medical Research Institute, Vienna, Austria

*Corresponding Author: Kurt Kraetschmer, MD, PhD, Austrian-American Medical Research Institute, Vienna, Austria.

Received: November 24, 2022 Published: December 19, 2022

Abstract

Background and Aim: On the background of claims that ulipristal acetate is the most effective hormonal medication for emergency contraception, the critical analysis investigates the pharmacological, medical, legal, and ethical aspects of this medication. The aim is to illuminate critical issues not yet sufficiently explored in research on emergency contraception.

Method and Material: The method is a critical analysis which assesses present knowledge contained in pertinent high-quality publications. The material encompasses articles published in high-ranked scientific journals and information disseminated by the most influential health agencies, such as the US Food and Drug Administration, the World Health Organization, the American College of Obstetricians and Gynecologists, and the American College of Pediatricians.

Results: The analysis of pharmacological aspects of ulipristal acetate shows that its similarity to mifepristone raises the question regarding abortifacient potentials of ulipristal acetate. The analysis of medical aspects of ulipristal acetate reveals that adverse events are not sufficiently described and that statistical methods for determining efficacy need to be refined. The analysis of legal aspects suggests that legislation on abortion medication might be relevant not only for mifepristone but also for ulipristal acetate. The analysis of ethical aspects unveils that the physiological processes of fertilization and implantation are crucial in discussions on the beginning of human life.

Conclusions and Implications: Concerning pharmacology it seems advisable to continue research on the mechanism of action of ulipristal acetate not only as a contraceptive but also as a contragestive. Concerning medical research, the efficacy of ulipristal acetate as a preventive therapy should be investigated with increased statistical verifiability. The results of these investigations should be communicated comprehensibly to the patient. Concerning legal aspects, the suitability of ulipristal acetate as abortion medication should be discussed on the basis of findings in human physiology. Concerning ethical debates the question of the beginning of life should be based on scientific insights into the physiological processes of ovulation, fertilization, and implantation.

Keywords: Contraception; Abortion; Pharmacology; Medicines; Ethics

References

1. Emergency Contraception. Practice Bulletin PB. Number 152. September 2015. ACOG (2022).
2. Brache V., et al. “Pharmacodynamics and pharmacokinetics of a copper intrauterine contraceptive system releasing ulipristal acetate: A randomized proof-of-concept study”. Contraception 4 (2021): 327-336.
3. Mazza D. “Ulipristal acetate: An update for Australian GPs”. Australian Family Physician5 (2017).
4. Rosato E., et al. “Mechanism of Action of Ulipristal Acetate for Emergency Contraception: A Systematic Review”. Frontiers in Pharmacology 6 (2015): 315.
5. Ulipristal acetate | C30H37NO4 - PubChem (nih.gov) (2022).
6. ellaOne 30 mg tablet. “Ulipristal acetate. Package leaflet: Information for the user”. ellaOne Package leaflet (hra-pharma.com) (2022).
7. DrugBank online. “Ulipristal: Uses, Interactions, Mechanism of Action” (2022).
8. Food and Drug and Drug Administration (FDA). “Birth Control Chart”. FDA (2021).
9. Mikolajczyk RT and Stanford JB. “A new method for estimating the effectiveness of emergency contraception that accounts for variation in timing of ovulation and previous cycle length”. Fertility and Sterility6 (2005): 1764-1770.
10. Levy DP., et al. “Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women”. Contraception 5 (2014): 431-433.
11. Australian Prescriber. “Ulipristal acetate for emergency contraception” 6 (2022).
12. HWR Li., et al. “Efficacy of ulipristal acetate for emergency contraception and its effect on the subsequent bleeding pattern when administered before or after ovulation”. Human Reproduction6 (2016): 1200-1207.
13. Trussell J., et al. “Emergency contraception: a last chance to prevent unintended pregnancy" (PDF). Princeton: Office of Population Research at Princeton University, Association of Reproductive Health Professionals. Archived from the original (PDF) on September 23, (2010).
14. Keenan JA. “Ulipristal acetate: contraceptive or contragestive?” Annals of Pharmacotherapy6 (2011): 813-815.
15. Food and Drug Administration (FDA). Mifeprix (Mifepristone) Information (2021).
16. Ware RS and Spitz IM. “Pharmacological properties of mifepristone: Toxicology and safety in animal and human studies”. Contraception6 (2003): 409-420.
17. Sitruk-Ware R., et al. “The Use of RU 486 as an Abortifacient in Early Pregnancy”. In: Baulieu, EE., Segal, S.J. (eds) The Antiprogestin Steroid RU 486 and Human Fertility Control. Reproductive Biology. Springer, Boston, MA. (1985).
18. “Hormonal contraception: methods and patient eligibility”. The Pharmaceutical Journal (2015).
19. The Wallstreet Journal. “Supreme Court Overturns Roe v. Wade, Eliminates Constitutional Right to Abortion”. Supreme Court Overturns Roe v. Wade, Eliminates Constitutional Right to Abortion – WSJ (2022).
20. Advocacy and Health Policy. “Understanding the Practical Implications of the FDA’s December 2021 Mifepristone REMS Decision”. ACOG (2022).
21. S. Senator Tina Smith Introduces Legislation to Protect Access to Medication Abortions. Senator Tina Smith (senate.gov) (2022).
22. Center for Reproductive Rights. “Laws and Regulations Affecting Medical Abortion” (2003).
23. Coast E., et al. “The microeconomics of abortion: A scoping review and analysis of the economic consequences for abortion care-seekers”. PLoS One6 (2022): e0252005.
24. IUD Paragard Lawsuit: What the Course of Litigation in 2022 Depicts. Posted by Jerin Jose Nesamony (2022).
25. “Did the FDA’s actions on the Essure contraceptive go far enough?” (2022).
26. Kraetschmer KK. “The Need for Rectifying Heterodoxies and Flawed Science in Publications on Contraception and Birth Control”. Journal of Clinical and Laboratory Research3 (2022).
27. Food and Drug Administration. Birth Control Levonorgestrel. Some side effects (2021).
28. When Human Life Begins. American College of Pediatricians. March (2017).

Citation

Citation: Kurt Kraetschmer. “Pharmacological, Medical, Legal, and Ethical Aspects of Emergency Contraception by Means of Ulipristal Acetate". Acta Scientific Pharmacology 4.1 (2023): 04-12.

Copyright

Copyright: © 2022 Kurt Kraetschmer. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.