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
|
|
Controlled Studies 1
|
STUDY 101-801 2
|
|
Active
|
Placebo
|
Active
|
Placebo
|
|
Uterine hyperstimulation with fetal distress
|
2.8%
|
0.3%
|
2.9%
|
0%
|
|
Uterine hyperstimulation without fetal distress
|
4.7%
|
0%
|
2.0%
|
0%
|
|
Fetal Distress without uterine hyperstimulation
|
3.8%
|
1.2%
|
2.9%
|
1.0%
|
|
N
|
320
|
338
|
102
|
104
|
1 Controlled Studies (with and without retrieval system)
2 Controlled Study (with retrieval system)
|
|
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).
DRUG ABUSE AND DEPENDENCE
No drug abuse or dependence has been seen with the use of Cervidil.
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