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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

  Controlled Studies1
Active Placebo
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%
N 320 338
  STUDY 101-8012
  Active Placebo
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%
N 102 104
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).

Post-marketing surveillance

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) .