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The creation of therapeutic orphans — or, what have we learnt from the Debendox fiasco?
Author(s) -
Batagol Ron,
Sheffield Leslie J.
Publication year - 1985
Publication title -
medical journal of australia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 131
eISSN - 1326-5377
pISSN - 0025-729X
DOI - 10.5694/j.1326-5377.1985.tb122871.x
Subject(s) - causation , causality (physics) , pregnancy , nausea , vomiting , drug , medicine , intensive care medicine , psychiatry , business , psychology , surgery , political science , law , biology , physics , quantum mechanics , genetics
The drug combination Debendox has been very widely used for the treatment of nausea and vomiting in pregnancy. Recently its manufacturer ceased world‐wide production owing to the increasing costs of litigation associated with claims of teratogenicity. Teratogenicity claims were widespread in the media but the overwhelming scientific evidence was that Debendox was not teratogenic. In the interests of preventing other drugs (and drug companies) being subjected to similarly unfounded claims, the literature relating to the effects of Debendox on the fetus has been reviewed and evaluated against well known epidemiological principles of establishing causality. This evaluation consistently demonstrates that Debendox is not in fact teratogenic. It is recommended that appropriate professional bodies be more aware of the criteria by which causation is established and be prepared publicly to state their considered views of the effects of particular drugs in pregnancy.