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Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes
Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes
original article
Ondansetron in Pregnancy and Risk
of Adverse Fetal Outcomes
Bjrn Pasternak, M.., P!.., "enrik #vanstrm, M.#c.,
and Anders "viid, r.Med.#ci.
A B # $ R A % $
From t!e e&artment of '&idemiology
Researc!, #tatens #erum (nstitut, %o&en)
!agen. Address re&rint re*uests to r.
Pasternak at t!e e&artment of '&idemi)
ology Researc!, #tatens #erum (nstitut,
Artillerivej +, ,-.. %o&en!agen #, en)
mark, or at / j& 0 s s i . d k .
$!is article was u&dated on Fe/ruary ,1,
,.2-, at 3'4M.org.
N Engl J Med 2013;368:814-23.
DOI:
10.1056/NEJMoa1211035
Copyright 2013 Massachusetts Medical Society.
Backgo!nd
Ondansetron is fre*uently used to treat nausea and vomiting during ®nancy,
/ut t!e safety of t!is drug for t!e fetus !as not /een well studied.
Me"#od$
5e investigated t!e risk of adverse fetal outcomes associated wit!
ondansetron administered during ®nancy. From a !istorical co!ort of 6.1,-1+
®nancies in enmark, women w!o were e7&osed to ondansetron and t!ose
w!o were not e7) &osed were included, in a 289 ratio, in &ro&ensity)score:
matc!ed analyses of s&on) taneous a/ortion ;219< e7&osed women vs. =-<6
une7&osed women>, still/irt! ;2<2+ vs. =66.>, any major /irt! defect ;2,-- vs.
9<-,>, &reterm delivery ;2=<, vs.
=261>, and /irt! of infants at low /irt! weig!t and small for gestational age
;2=19 vs. =2-6>. (n addition, estimates were adjusted for !os&itali?ation for
nausea and vomiting during ®nancy ;as a &ro7y for severity> and t!e use of
ot!er antiemetics.
%e$!l"$
Recei&t of ondansetron was not associated wit! a signif icantly increased risk
of s&ontaneous a/ortion, w!ic! occurred in 2.2@ of e7&osed women and -.=@ of
une7) &osed women during gestational weeks = to 2, ;!a?ard ratio, ..9<A <+@
conf idence interval B%(C, ..,= to ..<2> and in 2..@ and ,.2@, res&ectively,
during weeks 2- to
,, ;!a?ard ratio, ..6.A <+@ %(, ..,< to 2.,2>. Ondansetron also conferred no
sig) nif icantly increased risk of still/irt! ;..-@ for e7&osed women and ..9@ for
une7) &osed womenA !a?ard ratio, ..9,A <+@ %(, ..2. to 2.=->, any major /irt!
defect ;,.<@ and ,.<@, res&ectivelyA &revalence odds ratio, 2.2,A <+@ %(, ..6< to
2.1,>, &reterm delivery ;6.,@ and +.,@A &revalence odds ratio, ..<.A <+@ %(, ..66
to 2.,+>, delivery of a low)/irt!)weig!t infant ;9.2@ and -.=@A &revalence odds
ratio, ..=6A
<+@ %(, ..+2 to 2.2->, or delivery of a small)for)gestational)age infant ;2..9@
and
<.,@A &revalence odds ratio, 2.2-A <+@ %(, ..1< to
2.99>.
129
n engl j med -61A< nejm.org fe/ruary ,1, ,.2-
$!e 3ew 'ngland 4ournal of Medicine
ownloaded from nejm.org on May 2,, ,.29. For &ersonal use only. 3o ot!er uses wit!out &ermission.
%o&yrig!t D ,.2- Massac!usetts Medical #ociety. All rig!ts reserved.
&
o
n
c
l!$'on$
Ondansetron taken during ®nancy was not associated wit! a signif icantly
in) creased risk of adverse fetal outcomes. ;Funded /y t!e anis! Medical
Researc! %ouncil.>
129
n engl j med -61A< nejm.org fe/ruary ,1, ,.2-
$!e 3ew 'ngland 4ournal of Medicine
ownloaded from nejm.org on May 2,, ,.29. For &ersonal use only. 3o ot!er uses wit!out &ermission.
%o&yrig!t D ,.2- Massac!usetts Medical #ociety. All rig!ts reserved.
1,-
$!e 3ew 'ngland 4ournal of Medicine
ownloaded from nejm.org on May 2,, ,.29. For &ersonal use only. 3o ot!er uses wit!out &ermission.
%o&yrig!t D ,.2- Massac!usetts Medical #ociety. All rig!ts reserved.