ADVERSE REACTIONS
PREPIDIL Gel is generally well-tolerated. In controlled trials, in which 1731 women were entered, the following events were reported at an occurrence of ≥ 1%:
| Adverse Reaction | PGE2
(N = 884) | Controlplacebo gel or no treatment
(N = 847) |
|---|
| Maternal | N (%) | N (%) |
| Uterine contractile abnormality | 58 (6.6) | 34 (4.0) |
| Any gastrointestinal effect | 50 (5.7) | 22 (2.6) |
| Back pain | 27 (3.1) | 0 (0) |
| Warm feeling in vagina | 13 (1.5) | 0 (0) |
| Fever | 12 (1.4) | 10 (1.2) |
| Fetal | | |
| Any fetal heart rate abnormality | 150 (17.0) | 123 (14.5) |
| Bradycardia | 36 (4.1) | 26 (3.1) |
| Deceleration | | |
| Late | 25 (2.8) | 18 (2.1) |
| Variable | 38 (4.3) | 29 (3.4) |
| Unspecified | 19 (2.1) | 19 (2.2) |
In addition, in other trials amnionitis and intrauterine fetal sepsis have been associated with extra-amniotic intrauterine administration of PGE2. Uterine rupture has been reported in association with the use of PREPIDIL Gel intracervically. Additional events reported in the literature, associated by the authors with the use of PREPIDIL Gel, included premature rupture of membranes, fetal depression (1 min Apgar < 7), and fetal acidosis (umbilical artery pH < 7.15).
Post-marketing surveillance
Blood and lymphatic system disorders
An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by pharmacological means, either with dinoprostone or oxytocin (see section WARNINGS). The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labors).
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