The innocent bystander. Doxylamine/dicyclomine/pyridoxine and congenital limb defects

The antinausea drug combination, doxylamine/dicyclomine/pyridoxine (Debendox or Bendectin [US] ), has been withdrawn from the market because of litigation based upon charges that it causes congenital limb defects.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.