Levy Delphine P, Jager Martine, Kapp Nathalie, Abitbol Jean-Louis
Laboratoire HRA Pharma, Paris, France.
Laboratoire HRA Pharma, Paris, France.
Contraception. 2014 May;89(5):431-3. doi: 10.1016/j.contraception.2014.01.003. Epub 2014 Jan 13.
To describe the safety of ulipristal acetate in emergency contraception.
Postmarketing pharmacovigilance data collection.
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.
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.
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.
描述醋酸乌利司他用于紧急避孕的安全性。
上市后药物警戒数据收集。
共有553名女性出现了1049例药物不良反应。最常见的（例数，%）为妊娠（282例，6.8%）；恶心、腹痛和呕吐（139例，13.3%）；头痛、头晕（67例，6.4%）；以及子宫出血、月经推迟和乳房症状（84例，8.0%）。纳入临床试验数据后，总共报告了376例妊娠，其中232例（62%）有已知结局：28例活产（29名新生儿）、34例流产、151例人工流产、4例异位妊娠以及15例妊娠仍在继续。
在不同种族和地区，有大量报告的醋酸乌利司他暴露后不良反应数据库未显示出安全性问题。批准上市后的数据证实了临床试验中所描述的安全性特征。
在各种情况下和不同人群中使用醋酸乌利司他进行紧急避孕表明它是安全的，且没有意外或严重不良事件。
