Adverse drug reactions to tocolytic treatment for preterm labour: prospective cohort study.

Abstract:

OBJECTIVE:To evaluate the incidence of serious maternal complications after the use of various tocolytic drugs for the treatment of preterm labour in routine clinical situations. DESIGN:Prospective cohort study. SETTING:28 hospitals in the Netherlands and Belgium. PARTICIPANTS:1920 consecutive women treated with tocolytics for threatened preterm labour. MAIN OUTCOME MEASURES:Maternal adverse events (those suspected of being causally related to treatment were considered adverse drug reactions) leading to cessation of treatment. RESULTS:An independent panel evaluated the recorded adverse events, without knowledge of the type of tocolytic used. Of the 1920 women treated with tocolytics, 1327 received a single course of treatment (69.1%), 282 sequential courses (14.7%), and 311 combined courses (16.2%). Adverse drug reactions were categorised as serious or mild in 14 cases each. The overall incidence of serious adverse drug reaction was 0.7%. Compared with atosiban, the relative risk of an adverse drug reaction for single treatment with a beta adrenoceptor agonist was 22.0 (95% confidence interval 3.6 to 138.0) and for single treatment with a calcium antagonist was 12 (1.9 to 69). Multiple drug tocolysis led to five serious adverse drug reactions (1.6%). Multiple gestation, preterm rupture of membranes, and comorbidity were not independent risk factors for adverse drug reactions. CONCLUSIONS:The use of beta adrenoceptor agonists or multiple tocolytics for preventing preterm birth is associated with a high incidence of serious adverse drug reactions. Indometacin and atosiban were the only drugs not associated with serious adverse drug reactions. A direct comparison of the effectiveness of nifedipine and atosiban in postponing preterm delivery is needed.

journal_name

BMJ

authors

de Heus R,Mol BW,Erwich JJ,van Geijn HP,Gyselaers WJ,Hanssens M,Härmark L,van Holsbeke CD,Duvekot JJ,Schobben FF,Wolf H,Visser GH

doi

10.1136/bmj.b744

subject

Has Abstract

pub_date

2009-03-05 00:00:00

pages

b744

eissn

0959-8138

issn

1756-1833

journal_volume

338

pub_type

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