Point-of-care ultrasound in medical education--stop listening and look.

1083 know how many women, fearing that they had caused harm to their fetus, underwent elective abortions; anecdotal reports suggest that some did. The decades-long history of doxylamine–pyridoxine emphasizes the importance of making clinical decisions on the basis of scientific evidence. The FDA’s approval of Diclegis was based on efficacy and safety data from a randomized, placebo-controlled clinical trial and also took into account the extensive data described above showing that combined treatment with doxylamine succinate and pyridoxine hydrochloride is not teratogenic. These data reveal a favorable risk–benefit profile for Diclegis in the treatment of nausea and vomiting of pregnancy that has been refractory to nonpharmacologic treatment. Although combined doxylamine–pyridoxine treatment is already the single most studied pharmacologic therapy for use in pregnancy, the FDA will continue to carefully monitor postmarketing data related to Diclegis use. The Diclegis story reminds us that reliance on evidence-based practices, with the use of multiple streams of data, is the most appropriate way to evaluate drug safety.