Cervidil (dinoprostone) is well tolerated. In placebo-controlled trials in which 658 women were entered and 320 received active therapy (218 without retrieval system, 102 with retrieval system), the following events were reported.
Table 1 : Total Cervidil (dinoprostone) - Treated Drug Related Adverse Events
|Uterine hyperstimulation with fetal distress||2.8%||0.3%|
|Uterine hyperstimulation without fetal distress||4.7%||0%|
|Fetal Distress without uterine hyperstimulation||3.8%||1.2%|
|Uterine hyperstimulation with fetal distress||2.9%||0%|
|Uterine hyperstimulation without fetal distress||2.0%||0%|
|Fetal Distress without uterine hyperstimulation||2.9%||1.0%|
|1Controlled Studies (with and without retrieval system)
2Controlled Study (with retrieval system)
Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Cervidil (dinoprostone) .
In study 101-801 (with the retrieval system) cases of hyperstimulation reversed within 2 to 13 minutes of removal of the product. Tocolytics were required in one of the five cases.
In cases of fetal distress, when product removal was thought advisable there was a return to normal rhythm and no neonatal sequelae.
Five minute Apgar scores were 7 or above in 98.2% (646/658) of studied neonates whose mothers received Cervidil (dinoprostone) . In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Cervidil (dinoprostone) , there were no deleterious effects on physical examination or psychomotor evaluation (18).
Immune System Disorders: Hypersensitivity
Blood and lymphatic system disorders: Disseminated Intravascular Coagulation (See WARNINGS Section)
Reproductive system: Reports of uterine rupture have been reported in association with use of Cervidil (dinoprostone) some required a hysterectomy and some resulted in subsequent fetal or neonatal death.
Vascular Disorders: Hypotension
Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism
Drug Abuse And Dependence
No drug abuse or dependence has been seen with the use of Cervidil (dinoprostone) .