Maternal safety data
There has been vast clinical experience regarding the use of the Xonvea combination (doxylamine/pyridoxine combination) use in pregnancy dating back to 1956.1, 2
Side effects include:
- Nervous system disorders: somnolence (very common); dizziness (common)
- Gastrointestinal disorders: dry mouth (common)
- General disorders and administration site conditions: fatigue (common).
- Anticholinergic effects of Xonvea may be prolonged and intensified by monoamine oxidase inhibitors (MAOIs) and is therefore not recommended.
- Concurrent use with central nervous system (CNS) depressants including alcohol, hypnotic sedatives and tranquilizers is not recommended. The combination may result in severe drowsiness.
Warnings and Precautions:
- Xonvea has anticholinergic properties and, therefore, should be used with caution in patients with: asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and bladder-neck obstruction.
- Xonvea contains pyridoxine hydrochloride, a vitamin B6 analog, therefore additional levels from diet and vitamin B6 supplements should be assessed.
In a randomised, double-blind, multicentre placebo controlled trial comparing Xonvea (n=131) versus placebo (n=125) in pregnant women suffering from NVP, the safety profile of Xonvea was consistent with the Summary of Product Characteristics.15
|Treatment emergent adverse events1
|Loss of consciousness
There was a 15% increased drop-out rate with those taking placebo vs. Xonvea combination.
A secondary analysis of study DIC-301 sought to evaluate the maternal safety of delayed-release doxylamine/pyridoxine combination in treating NVP compared to placebo, in more detail.16
This analysis demonstrated that doxylamine/pyridoxine combination was well tolerated by pregnant women when used in the recommended dose of up to 4 tablets daily in treating NVP. Moreover, doxylamine/pyridoxine use was not associated with an increased rate of any AE over placebo, including CNS depression, gastrointestinal or cardiovascular involvement.
Please read the product’s prescribing information for a full list of the adverse events for this medication.
Prescribing information and adverse events reporting