[Adverse drug reactions in pregnant women].
A Prospective pharmacovigilance survey of adverse drug reactions (ADRs) in pregnant women was performed in collaboration with gynaecologists and obstetricians of Midi-Pyrenees area (south west of france). The aim of the study was to evaluate the incidence of adverse drug reactions in pregnant women. The incidence of ADRs in pregnant women was low: 0.3%. Moreover, a retrospective pharmacoepidemiological study was conducted to characterize ADRs in pregnant women. Reports of ADRs collected in the Midi-Pyrenees pharmacovigilance centre from 1982 to 2002 were used: type of ADRs, drugs involved and potential risk factors were compared for pregnant women and for age-matched non pregnant women. Forty seven and 94 reports of ADRs were collected in pregnant and non-pregnant women respectively. Anaphylactic reactions were only observed in pregnant women (3 cases, p = 0.04). We observed 1 ADR related stillbirth (due to anaphylactic reaction) in pregnant women. Drugs for gynaecological and cardiovascular systems were more frequently involved in ADRs in pregnant women than in controls. ADRs mainly occurred during the third trimester of pregnancy. The incidence of ADRs is very low in pregnant women. However, one must pay attention on the risk of anaphylactic reactions in pregnant women.
Lacroix
Isabelle
I
Laboratoire de Pharmacologie Médicale et Clinique, Unité de Pharmacoépidémiologie, EA 3696, Université de Toulouse, Faculté de Médecine, Toulouse, France. lacroix@cict.fr
Cabou
Cendrine
C
Montastruc
Jean-Louis
JL
Damase-Michel
Christine
C
D011307:Drug Prescriptions / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005602:France; D006306:Health Surveys; D006801:Humans; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy / Q000453:epidemiology; D011446:Prospective Studies