Cervidil (Dinoprostone Vaginal) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Cervidil 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 – Treated Drug Related Adverse Events

1Controlled Studies (with and without retrieval system)
2Controlled Study (with retrieval system)
	Controlled Studies 1
	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 101-801 2
	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

In Postmarketing Experience Reports, uterine rupture has been reported in association with the use of Cervidil.

Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Cervidil.

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. In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Cervidil, there were no deleterious effects on physical examination or psychomotor evaluation (18).

REPORTS OF SUSPECTED CERVIDIL SIDE EFFECTS / ADVERSE REACTIONS

Possible Cervidil side effects / adverse reactions in 36 year old female

Reported by a pharmacist from United Kingdom on 2011-10-11

Patient: 36 year old female weighing 61.0 kg (134.2 pounds)

Reactions: Defaecation Urgency, Uterine Hypertonus, Maternal Exposure During Pregnancy, Abdominal Discomfort, Bradycardia Foetal, Foetal Distress Syndrome, Gastrointestinal Pain, Caesarean Section, Hypertension

Adverse event resulted in: hospitalization

Suspect drug(s):
Cervidil

Other drugs received by patient: Human Protaphane (Insulin Human Injection, Isophane) (Injection) (Insu; Novolog; Fefol (Folic Acid)

Possible Cervidil side effects / adverse reactions in 33 year old female

Reported by a physician from United States on 2011-12-27

Patient: 33 year old female weighing 72.5 kg (159.5 pounds)

Reactions: Caesarean Section, Maternal Drugs Affecting Foetus, Foetal Heart Rate Deceleration, Uterine Contractions Abnormal, Premature Separation of Placenta

Adverse event resulted in: life threatening event

Suspect drug(s):
Cervidil

Possible Cervidil side effects / adverse reactions in 33 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-14

Patient: 33 year old female

Reactions: Product Quality Issue, Caesarean Section, Premature Separation of Placenta, Maternal Exposure During Pregnancy

Suspect drug(s):
Cervidil