T h e n e w e n g l a n d j o u r n a l o f m e d i c i n e

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 .
$!is article was u&dated on Fe/ruary ,1,
,.2-, at 3'4M.org.
N Engl J Med 2013;368:814-23.
DOI:
10.1056/NEJMoa1211035
Copyright 2013 Massachusetts Medical Society.
Backgo!nd
Ondansetron is fre*uently used to treat nausea and vomiting during &regnancy,
/ut t!e safety of t!is drug for t!e fetus !as not /een well studied.
Me"#od$
5e investigated t!e risk of adverse fetal outcomes associated wit!
ondansetron administered during &regnancy. From a !istorical co!ort of 6.1,-1+
&regnancies 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 &regnancy ;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 &regnancy 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.