The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?
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.
D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000818:Animals; D000932:Antiemetics / Q000009:adverse effects*; D001315:Australia; D002986:Clinical Trials as Topic; D003509:Cyclohexanecarboxylic Acids / Q000009:adverse effects*; D004025:Dicyclomine / Q000009:adverse effects*; D004319:Doxylamine / Q000009:adverse effects*; D004338:Drug Combinations / Q000009:adverse effects; D005260:Female; D000882:Haplorhini; D006801:Humans; D007231:Infant, Newborn; D008252:Macaca fascicularis; D011247:Pregnancy; D011725:Pyridines / Q000009:adverse effects*; D011736:Pyridoxine / Q000009:adverse effects*; D011817:Rabbits; D011897:Random Allocation; D051381:Rats; D012306:Risk; D013723:Teratogens; D014481:United States; D014486:United States Food and Drug Administration
D000932:Antiemetics; D003509:Cyclohexanecarboxylic Acids; D004338:Drug Combinations; D011725:Pyridines; D013723:Teratogens; C004454:dicyclomine, doxylamine, pyridoxine drug combination; D004025:Dicyclomine; D004319:Doxylamine; D011736:Pyridoxine