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The innocent bystander: Doxylamine/dicyclomine/pyridoxine and congenital limb defects
Author(s) -
McCredie Janet,
Kricker Anne,
Elliott Jane,
Forrest Jill
Publication year - 1984
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.1326-5377.1984.tb108224.x
Subject(s) - medicine , pyridoxine , pregnancy , pediatrics , anesthesia , biology , genetics
The antinausea drug combination, doxylamine/dicyclomine/pyridoxine (Debendox or Bendectin [US]), has been withdrawn from the market because of litigation based upon charges that it causes congenital limb defects. To investigate this allegation, the pregnancy histories of mothers of 155 limb‐deficient children, born between 1970 and 1981, have been compared with those of mothers of 273 matched normal controls. There was no significant difference between the pregnancy histories of mothers of case children and those of mothers of control children in respect of reported frequency of morning sickness, the use of doxylamine/dicyclomine/pyridoxine, the date of commencement of its intake, the duration of intake, or its dose. The relative risk of limb deficiency in children of mothers exposed to this drug is estimated to be 1.1 with confidence limits of 0.8‐1.5. No risk of congenital limb defects was found to be associated with the use of this drug.