Labeling for Nausea Drugs Used During Pregnancy Updated With New Warning

The Food and Drug Administration (FDA) has approved drug safety labeling changes for Duchesnay‘s Diclegis (doxylamine succinate 10mg, pyridoxine HCl 10mg delayed-release tablets) and Bonjesta (doxylamine succinate 20mg, pyridoxine HCl 20mg extended-release tablets).

The Warnings and Precautions section for both products has been updated to inform clinicians that there have been reports of false positive urine screening tests for methadone, opiates, and phencyclidine phosphate (PCP) with doxylamine succinate/pyridoxine hydrochloride use. In the event of a positive immunoassay result, confirmatory tests, such as gas chromatography mass spectrometry (GC-MS), should be used to confirm the identity of the substance. 

The Drug Interactions and Patient Counseling Information sections for both drugs have also been updated to reflect the false positive urine test warning.

Diclegis and Bonjesta are both indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. These products have not been studied in women with hyperemesis gravidarum.

For more information visit Diclegis.com or Bonjesta.com.