FDA Approval of Doxylamine–Pyridoxine Therapy for Use in Pregnancy

Hyperemesis Gravidarum

“…These concerns were ultimately determined to be unjustified after 2 large meta‐analyses studies including >200,000 women showed no difference in risk for birth defects infants among those who were born to mothers who had taken or had not taken Bendectin . In 2013, the FDA approved the return of a combination formulation of vitamin B6 and doxylamine for NVP, and in 2016, an extended release version, Diclegis (Duchesney, Bryn Mawr, PA), became available for women with NVP not responding to dietary and lifestyle changes . Notably, women can also obtain the components of these combination pills over the counter and take 10 mg of vitamin B6 and 12.5 mg of Unisom (Chattem Inc, Chattanooga, TN) individually.…”

“…112,113 In 2013, the FDA approved the return of a combination formulation of vitamin B6 and doxylamine for NVP, and in 2016, an extended release version, Diclegis (Duchesney, Bryn Mawr, PA), became available for women with NVP not responding to dietary and lifestyle changes. 114,115 Notably, women can also obtain the components of these combination pills over the counter and take 10 mg of vitamin B6 and 12.5 mg of Unisom (Chattem Inc, Chattanooga, TN) individually.…”

Nausea and vomiting of pregnancy: Effects on quality of life and day‐to‐day function

“…As with prior studies, we found low NVP treatment rates despite NVP's QoL impact, even in those with moderate/severe symptoms. This likely reflects fear of medication use during pregnancy post‐thalidomide and downplaying of NVP's impact . In previous studies, women felt general practitioners’ normalisation of NVP trivialised their symptoms, and these attitudes act as a further obstacle to NVP sufferers seeking help compared to other medical conditions.…”

Doxylamine/pyridoxine for nausea and vomiting in pregnancy

“…In 1983, following claims that the product was a teratogen, the manufacturer voluntarily withdrew the product for non-medical reasons despite an absence of evidence linking it with an increased risk of birth defects 9,10. Epidemiological studies, meta-analyses and data maintained by the USA Birth Defect Monitoring Program of the Centers for Disease Control and Prevention have since suggested that Bendectin is not a human teratogen and is not associated with birth defects 10. Since 1979, a delayed-release formulation containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride (Diclectin) has been available in Canada 9.…”