Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women

Abstract

Objective: To describe the safety of ulipristal acetate in emergency contraception.

Study design: Postmarketing pharmacovigilance data collection.

Results: A total of 553 women experienced 1049 adverse drug reactions. The most frequent (n,%) were pregnancies (282, 6.8%); nausea, abdominal pain and vomiting (139, 13.3%); headache, dizziness (67, 6.4%); and metrorrhagia, menses delay and breast symptoms (84, 8.0%). Including data from clinical trials, 376 pregnancies have been reported in total, 232 (62%) with a known outcome: 28 live births (29 newborns), 34 miscarriages, 151 induced abortions, 4 ectopics and 15 which are ongoing.

Conclusions: No safety concern emerges from a sizable database of reported adverse reactions following ulipristal acetate exposure among varying ethnicities and regions. Postapproval data confirm the safety profile described during the clinical trials.

Implications: Use of ulipristal acetate for emergency contraception in a variety of settings and among diverse populations indicate that it is safe and without unexpected or serious adverse events.

Keywords: Adverse drug reactions; Drug safety; Ella; EllaOne; Pharmacovigilence; Safety of EC; Safety profile of ella.