gms | German Medical Science

10. Jahrestagung der GAA Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

16. bis 17.10.2003, Bonn

Clenbuterol: off-label-use in pregnancy in Germany

Clenbuterol: Off-label-use in der Schwangerschaft

Meeting Abstract

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  • corresponding author Veronika Egen-Lappe - Institut für Med. Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Universität München, Marchioninistr. 15, 81377 München, Tel.: 089 7095 7481
  • J. Hasford - Institut für Med. Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Universität München, Marchioninistr. 15, 81377 München

Gesellschaft für Arzneimittelanwendungsforschung u. Arzneimittelepidemiologie (GAA) e.V.. 10. Jahrestagung der Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie (GAA) e.V.. Bonn, 16.-17.10.2003. Düsseldorf, Köln: German Medical Science; 2003. Doc03gaa10

The electronic version of this article is the complete one and can be found online at:

Published: October 16, 2003

© 2003 Egen-Lappe et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Background and Aim

Clenbuterol is a beta sympathomimetic drug. In Germany it is licensed only to be used as a bronchodilator. A study on drug use in pregnancy has reported Clenbuterol being used for arresting labor. Another drug of the same class, Fenoterol, however, is licensed for this purpose. The aim of the study was to quantify the magnitude of the off-label-use of clenbuterol in a large sickness fund data base in Germany.

Material and Method

Prescription data of all women in Germany insured at a particular sickness fund who gave birth within June 2000 and May 2001 was analysed. 41,293 pregnancies that comprised the database constituted roughly 5 % of yearly pregnancies in Germany.


Clenbuterol was prescribed to only four women each in the half year before pregnancy and in the first trimester of the pregnancy, respectively. In the second and third trimesters of pregnancy 502 women (1.2 %) received at least one prescription - 134 women (0.3 %) in the second trimester and 435 (1.1 %) in the third trimester. These 502 women got total of 968 prescriptions of Clenbuterol, on average 1.9 each. The median was one. Most prescriptions (94 %) were issued by gynaecologists. On the other hand Fenoterol was prescribed to 1387 women (3.4 %) in the second or/and third trimesters. 40 women received both these drugs.


1.1 % of the pregnant women received an off-label prescription of clenbuterol for arresting labor. Clenbuterol constituted 25 % share of total prescriptions, whereas fenoterol constituted 75 %. Reasons for the physicians to prescribe clenbuterol could have been the better oral resorption and longer half-life period of the drug. However, prescribing a drug whose efficacy and safety has not been evaluated by a drug authority could be a risk to the patient's health and a risk in terms of liability to the physician.