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The Emergency Contraception Pill Ulipristal Acetate Is as Safe as Expected

Summary and Comment |
May 29, 2014

The Emergency Contraception Pill Ulipristal Acetate Is as Safe as Expected

  1. Anne Moore, DNP, APN, FAANP

Postmarketing data confirm the safety and tolerability of this form of EC.

  1. Anne Moore, DNP, APN, FAANP

Ulipristal acetate (UPA; 30 mg) is a relative newcomer to the arena of emergency contraception (EC). In a manufacturer-funded study, researchers used international postmarketing surveillance data (>1,400,000 women; October 2009 to May 2013) to further explore the safety and tolerability of UPA.

A total of 553 women reported 1049 adverse drug reactions associated with UPA. Pregnancy occurred in 282 UPA users; combined with the 94 pregnancies that were observed in clinical trials, a total of 376 exposed pregnancies occurred. Among 232 pregnancies with known outcomes, 151 resulted in induced abortions, 28 resulted in uncomplicated live births, and rates of first-trimester miscarriage and ectopic pregnancy compared favorably with those in the general population. Other adverse reactions included gastrointestinal effects (13%; nausea, vomiting, abdominal pain), reproductive symptoms (8%; abnormal uterine bleeding, delay of menses, breast pain), and neurologic effects (6%; headache, dizziness). All such symptoms were reported as mild or moderate.

Comment

The selective progesterone-receptor modulator ulipristal acetate 30 mg has been called the new gold standard emergency contraceptive pill. Used widely in Europe since 2009 and approved for use in the U.S. in 2010, this EC pill is superior to levonorgestrel EC because it more effectively prevents ovulation when taken 5 days following unprotected intercourse. Safety information such as this should go a long way toward convincing clinicians to prescribe UPA rather than having their patients depend on over-the-counter EC pills.

Editor Disclosures at Time of Publication

  • Disclosures for Anne Moore, DNP, APN, FAANP at time of publication Consultant / Advisory board Noven Equity Actavis plc Speaker’s bureau Merck; Actavis plc Editorial boards Updates in Clinical Medicine; Journal of Obstetic, Gynecologic, & Neonatal Nursing

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