gms | German Medical Science

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.

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.