[Clomiphene-exposed pregnancies--analysis of 39 information requests including 25 cases with known outcome].
With the up to date published data, the risk of clomiphene exposure during pregnancy cannot be determined. After a review of animal experimentation results, we will discuss the human data. Most of the publications with human exposition concern treatments given before the beginning of pregnancy. The questions addressed to the Centre de Pharmacovigilance of Paris F. Widal will be detailed. From May 1983 to July 1995 39 requests are available with only 25 cases of known outcomes. For these 25 cases, five elective terminations and three spontaneous abortions are reported. Only one defect was observed among the 17 births (9 females, 8 males): unilateral fibula agenesis the imputability of which is difficult to establish. These data seems reassuring; however, the number of patients studied is small. Other studies on clomiphene-exposed pregnancies are necessary in order to investigate this risk.
Carlier
P
P
Centre Régional de Pharmacovigilance Hôpital Fernand Widal, Paris, France.
Choulika
S
S
Efthymiou
M L
ML
D000014:Abnormalities, Drug-Induced / Q000209:etiology; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000818:Animals; D002996:Clomiphene / Q000009:adverse effects*; D005260:Female; D005300:Fertility Agents, Female / Q000009:adverse effects*; D005500:Follow-Up Studies; D006801:Humans; D010297:Paris; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced*
D005300:Fertility Agents, Female; D002996:Clomiphene