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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO CERVIDIL

Possible Cervidil side effects / adverse reactions in 30 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2007-06-27

Patient: 30 year old female weighing 71.5 kg (157.3 pounds)

Reactions: Placental Infarction, Uterine Atony, Haemoglobin Decreased, Caesarean Section, Haematocrit Decreased, Drug Exposure During Pregnancy, NO Therapeutic Response, Surgical Failure, PRE-Eclampsia

Adverse event resulted in: life threatening event, hospitalization, disablity

Suspect drug(s):
Cervidil

Other drugs received by patient: Zolpidem Tartrate; Tylenol (Caplet)

Possible Cervidil side effects / adverse reactions in 30 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2007-07-06

Patient: 30 year old female weighing 71.5 kg (157.3 pounds)

Reactions: Postpartum Haemorrhage, Caesarean Section, Apgar Score LOW, Body Temperature Increased, Drug Exposure During Pregnancy, Foetal Heart Rate Deceleration, Uterine Atony, Foetal Heart Rate Abnormal, Tachycardia Foetal

Adverse event resulted in: life threatening event, hospitalization, disablity

Suspect drug(s):
Cervidil

Other drugs received by patient: Zolpidem Tartrate; Tylenol (Caplet); Intravenous Fluids; Epidural OR Regional Anesthesia; Oxygen

Possible Cervidil side effects / adverse reactions in 26 year old female

Reported by a consumer/non-health professional from United States on 2007-07-20

Patient: 26 year old female

Reactions: Rubella Antibody Positive, Inappropriate Schedule of Drug Administration, Drug Dose Omission, Drug Exposure During Pregnancy, Heart Rate Increased, Amniocentesis Abnormal, Pregnancy

Suspect drug(s):
Claravis
    Dosage: 40 mg, bid, oral
    Administration route: Oral
    Start date: 2006-02-07
    End date: 2006-08-13

Ortho TRI-Cyclen LO
    Dosage: 1 tablet, qd, oral
    Administration route: Oral
    Indication: Oral Contraception

Cervidil

Other drugs received by patient: Chitosan (Poliglusam); Isotrim (Sulfamethoxazole, Trimethoprim); Vita-PAK