SOGC Statement on Recent Reports on Diclectin
The Society of Obstetricians and Gynaecologists of Canada (SOGC) wishes to reassure members and concerned women that the recent publication regarding Diclectin (doxylamine/pyridoxine) did not relate to patient safety, nor did it contradict any of the many studies showing efficacy of Diclectin. It did not bring forward any new information.
The overwhelming body of evidence shows that Diclectin is safe and effective for treating nausea and vomiting in pregnancy. Our guideline, The Management of Nausea and Vomiting of Pregnancy, released in December 2016, reviews the use of Diclectin and other pharmacologic treatments, of which Diclectin was found to be an appropriate first choice, and many non-pharmacological options such as dietary manipulation, ginger supplements or acupressure.
The researcher published work that was done in 1970—47 years ago, that did not show any concerns with Diclectin. In fact, that study showed Diclectin to be effective. The study however, had minor methodological flaws and, therefore, was never published. It should be noted that the research was conducted in the 1970s and research methodology has improved since then. No findings adverse to the doxylamine/pyridoxine option were found in the study or its subsequent review.
The conclusions drawn by the SOGC Guideline Committee were based on a body of more current and methodological evidence. Even if the research from the 1970s was dismissed, it is irrelevant to the strength and conclusions of our recent Guideline.
Health Canada conducted an independent review of Diclectin as part of its product review policy in the summer of 2016. It concluded that Diclectin's benefits continue to outweigh its risks, when used as authorized. The results of the Health Canada report can be reviewed here.
Nausea and vomiting in pregnancy is a common condition causing significant distress for many pregnant women. Healthcare providers should continue to assist women with this condition including recommending Diclectin, if indicated. Women should remain assured that this drug is very safe and moderately effective.
If you have any concerns, please contact the SOGC at firstname.lastname@example.org.
- See the PDF statement
- Health Canada Summary Safety Review - DICLECTIN (doxylamine and pyridoxine combination) - Assessing Safety in pregnancy