NEUROSTAR

Additional Manufacturer Narrative

THIS ADVERSE EVENT IS SUBMITTED TO THE AGENCY LATE AS A CORRECTIVE ACTION SINCE IT WAS WAS DETERMINED TO BE REPORTABLE AFTER AN AUDIT OF THE COMPANY'S COMPLAINT DATABASE.

Description of Event or Problem

MIGRAINE ASSOCIATED NAUSEA/VOMITING WAS DISRUPTIVE TO DAILY ROUTINE. PATIENT REPORTEDLY EXPERIENCED VOMITING EVERY DAY FOLLOWING TREATMENT. PATIENT HAD A HISTORY OF MIGRAINES BUT WERE REPORTEDLY NEVER AS BAD AS THESE. AS A RESULT PATIENT WAS PRESCRIBED ZOFRAN AND WAS ABLE TO COMPLETE TREATMENT.