Health Professional Information: About Diclectin's safety

Diclectin® (doxylamine/pyridoxine) scored the highest safety rating "A" in Briggs' Reference Guide on Drugs in Pregnancy and Lactation. 

The safety of Diclectin® is supported by an abundance of scientific evidence published in the peer-reviewed medical literature.  To know more about the published studies on Diclectin®, click on the Research Activities heading in the left column.

Diclectin® has been the subject of many epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. Two separate meta-analyses have been conducted to assess pregnancy outcome following the use of a combination of doxylamine succinate and pyridoxine hydrochloride during the first trimester. McKeigue et al conducted a meta-analysis of 16 cohort and 11 case-control studies published between 1963 and 1991. No increased risk for malformations was found in first trimester exposures to doxylamine succinate and pyridoxine hydrochloride.

A second meta-analysis, conducted by Einarson et al, incorporated 12 cohort and 5 case-control studies. No statistically significant relationships were found between first trimester use of the Diclectin®'s combination and fetal abnormalities. In 1989, a report confirming the safety of Diclectin® for use in the management of nausea and vomiting of pregnancy was prepared by a panel of experts for the Special Advisory Committee on Reproductive Physiology to the Health Protection Branch of Health Canada.