Effects of cabergoline on pregnancy and embryo-fetal development: retrospective study on 103 pregnancies and a review of the literature.
The aim of the study is to assess the rate of any potential adverse effects on women who became pregnant under cabergoline (CAB) treatment and to evaluate any effects on the embryo-fetal development and on children who were born from mothers exposed to CAB in early weeks of gestation. Observational, retrospective and multicenter study on 103 pregnancies in 90 women with hyperprolactinemia. All patients were under CAB at conception. Serum prolactin at baseline was between 30 and 1921 ng/ml. Duration of therapy before pregnancy ranged from 1 to 120 months and doses ranged from 0.125 to 5 mg/week. Fetal exposure ranged from 3 to 25 weeks, 96.9% of patients received CAB during the first trimester of pregnancy and the rest until the second one. No significant complications during pregnancy were found. Seven women (7.2%) had spontaneous abortions. Preterm deliveries were recorded in eight (8.8%), only one with low weight for gestational age. Neonatal abnormalities were observed in 3 (3.6%): 1 major (Down syndrome) and 2 minor malformations (umbilical and inguinal hernia). We were able to asses the children's development in 61. Two had epilepsy and two had Pervasive Developmental Disorder (PDD). No significantly higher frequency of complications was found in pregnancies and/or offspring exposed to CAB than in the normal population. We registered 2 abnormalities in the development of the children: epilepsy and PDD. Larger series of patients are needed to assess the safety of this drug during pregnancy.
Stalldecker
Graciela
G
Departamento de Neuroendocrinología, Sociedad Argentina de Endocrinología y Metabolismo, Diaz Velez 3889, 1200 Buenos Aires, Argentina, graciela.stalldecker@gmail.com
Mallea-Gil
María Susana
MS
Guitelman
Mirtha
M
Alfieri
Analía
A
Ballarino
María Carolina
MC
Boero
Laura
L
Chervin
Alberto
A
Danilowicz
Karina
K
Diez
Sabrina
S
Fainstein-Day
Patricia
P
García-Basavilbaso
Natalia
N
Glerean
Mariela
M
Gollan
Viviana
V
Katz
Débora
D
Loto
Mónica Graciela
MG
Manavela
Marcos
M
Rogozinski
Amelia Susana
AS
Servidio
Marisa
M
Vitale
Nicolás Marcelo
NM
D000328:Adult; D000077465:Cabergoline; D003430:Cross-Sectional Studies; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004873:Ergolines / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005865:Gestational Age; D006801:Humans; D006966:Hyperprolactinemia / Q000188:drug therapy*; D008875:Middle Aged; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced*; D047928:Premature Birth / Q000139:chemically induced; D011388:Prolactin / Q000097:blood; D012189:Retrospective Studies; D055815:Young Adult
D018491:Dopamine Agonists; D004873:Ergolines; D011388:Prolactin; D000077465:Cabergoline