Flawed invisible trial underpins US morning sickness drug, researchers say

BMJ 2017; 356 doi: (Published 09 January 2017) Cite this as: BMJ 2017;356:j132
  1. Owen Dyer

A 1975 trial that led to the approval of the US’s only approved morning sickness drug—long buried in the Food and Drug Administration archives but newly published—is marred by “questionable data integrity” and should not be relied on “because of the high risk of bias,” say researchers who obtained the original trial from the FDA under a freedom of information request and published it in the journal PLoS One.1

The 40 year old research has been cited frequently by the FDA, Health Canada, and the drug’s manufacturer, Duchesnay, as the principal evidence for the safety and efficacy of the vitamin B6/doxylamine combination, formerly known as Bendectin …

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