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The ne w e ngl a nd jour na l of me dic ine

originalarticle

Ondansetron in Pregnancy and Risk

of Adverse Fetal OutcomesBjrn Pasternak, M.., P!.., "enrik #vanstrm, M.#c.,

and Anders "viid, r.Med.#ci.

AB#$R A%$

From t!e e&artment of '&idemiologyResearc!, #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&0ssi.dk.

$!is article was u&dated on Fe/ruary1,2-, at3'4M.org.

N Engl JMed 2013;368:814 -23.

DOI:

10.1056/NEJMoa1211035

Copyright 2013Massachusetts 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 61,-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!edanalyses of s&on) taneous a/ortion ;219< e7&osed women vs. =-, still/irt! ;2, any major /irt! defect ;2-- vs.

9, &reterm delivery ;2=, 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 significantly 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

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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.>

129n engl j med -61< nejm.org fe/ruary1, .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.

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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.