Boxed Warning | 3/2016 |
Indications and Usage ( |
3/2016 |
Dosage and Administration, Dosing Regimen ( |
3/2016 |
Dosage and Administration, Post-treatment Assessment: Day 7 to 14 ( |
3/2016 |
Warnings and Precautions, Mifepristone REMS Program ( |
3/2016 |
Warnings and Precautions, Ectopic Pregnancy ( |
3/2016 |
|
studies |
Women |
frequency (%) |
Reporting Outcome |
|
3 | 1,248 | 51-75% | 70 days |
|
2 | 630 | 55-58% | 63 days |
|
1 | 414 | 48% | 63 days |
|
3 | 1,248 | 37-48% | 70 days |
|
2 | 630 | 41-44% | 63 days |
|
3 | 1,248 | 18-43% | 70 days |
|
2 | 630 | 39-41% | 63 days |
|
||||||
Reaction |
|
|
||||
|
|
frequency (%) |
studies |
Evaluable Women |
frequency (%) |
|
|
4 | 17,774 | 0.03-0.5% | 3 | 12,134 | 0-0.1% |
|
1 | 629 | 0.2% | 1 | 11,155 | <0.01%* |
|
2 | 1,043 | 2.9-4.6% | 1 | 95 | 0 |
Related to Medical Abortion |
3 | 14,339 | 0.04-0.6% | 3 | 1,286 | 0-0.7% |
sepsis |
1 | 216 | 0 | 1 | 11,155 | 0.2% |
|
NR | NR | NR | 1 | 11,155 | 0.1% |
|
|
|
|
16,794 | 18,425 |
|
97.4% | 96.2% |
|
2.6% | 3.8% |
|
0.7% | 0.9% |
* Reasons for surgical intervention include ongoing pregnancy, medical necessity, persistent or heavy bleeding after treatment, patient request, or incomplete expulsion. ** Ongoing pregnancy is a subcategory of surgical intervention, indicating the percent of women who have surgical intervention due to an ongoing pregnancy. |
|
|
|
|
|||||||||
|
|
Evaluable Studies |
|
|
Evaluable Studies |
|
|
Evaluable Studies |
|
|
Evaluable Studies |
|
medical abortion |
12,046 | 98.1 | 10 | 3,941 | 96.8 | 7 | 2,294 | 94.7 | 9 | 479 | 92.7 | 4 |
intervention for ongoing pregnancy |
10,272 | 0.3 | 6 | 3,788 | 0.8 | 6 | 2,211 | 2 | 8 | 453 | 3.1 | 3 |