Evidence mounts yet again against efficacy of common morning sickness pill

pharmafile | January 18, 2018 | News story | Research and Development Diclegis, morning sickness, pharma 

Evidence is mounting against the efficacy of the common morning sickness pill pyridoxine-doxylamine  (Diclegis, Diclectin), as new study data reveals that it may not actually aid the relief of nausea, and is leading some doctors to advise against prescribing the drug.

Researchers have reported previously unpublished data from a trial in 2010 which led to the FDA approving the treatment suggest that the difference in efficacy between it and placebo at reducing nausea and vomiting in pregnant women could not be considered clinically meaningful, with the 101 women who took the drug achieving just 0.7% greater reduction in symptoms on a 13-point scale than the 86 who were given placebo. The unpublished records indicate that a 3-point greater reduction would need to be achieved to be considered clinically meaningful.

Dr Nav Persaud, lead author of the study and family physician at St Michael’s Hospital and the University of Toronto, co-authored a re-analysis of a clinical trial from the 1970s in January 2017, when Diclegis was originally developed, and, in line with the current study’s findings, found that missing data made it difficult to assess the efficacy of the medicine.

“I have stopped prescribing this medication,” Dr Persaud told Reuters by email. “Based on all the information available, I don’t think that it works.”

However, despite being aware of the current study, the American College of Obstetricians and Gynecologists (ACOG) reiterated their recommendation in December last year that Diclegis be prescribed for nausea before considering alternative medications.

Dr Mark Turrentine, Chair of ACOG’s committee, commented: “If the US Food and Drug Administration, the authors of the original studies, or the drug manufacturer, correct or retract any of the evidence used to develop ACOG’s guidance, we will reassess.”

Matt Fellows

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