UBIT (13C-UREA) TABLET, 100MG MILLIGRAM(S)

Description of Event or Problem

RASH GENERALISED [RASH GENERALISED]. CASE DESCRIPTION: THIS IS A CASE OF RASH REPORTED TO DRUG INFO CENTER AT (B)(6) BY A PHARMACIST. FOLLOW-UP INFO RECEIVED: THE REPORTED EVENT OF RASH WAS UPDATED TO GENERALISED RASH, AND THIS CASE WAS UPGRADED TO SERIOUS AT THE TIME OF THIS REPORT. ON (B)(6) 2012, A PT WITH UNDERLYING ACUTE GASTRITIS EXPERIENCED GENERALISED RASH ON THE DAY OF START OF UBIT (13C-UREA). THE PT WAS IN HIS (B)(6). AT 0900 IN THE MORNING ON (B)(6) 2012, THE PT RECEIVED 13C-UREA 100 MG/DAY. IN THAT EARLY EVENING, HE EXPERIENCED RASH AND VISITED A NEARBY HOSPITAL. RASH (GENERALISED) DEVELOPED. ANTIALLERGIC AGENTS AND STEROID OINTMENT WERE PRESCRIBED AT THE NEARBY HOSPITAL AND THE RASH (GENERALISED) WAS RESOLVING ON AN UNK DATE. THE PHARMACIST COMMENTED AS FOLLOWS: ALTHOUGH SITUATION OF OTHER MEDICATION USE WAS UNK, AS PER THE PHYSICIAN, 13C-UREA WAS SUSPECTED TO BE THE CAUSE. THE PRESCRIBING PHYSICIAN COMMENTED AS FOLLOWS: THE REASON WHY THE OUTCOME WAS NOT "RESOLVED" WAS BECAUSE THE PT HAD SCRATCHED DUE TO STRONG ITCHING. WHILE THE REPORTING PHYSICIAN REPORTED THE EVENT AS NON-SERIOUS, THE COMPANY JUDGED IT TO BE "MEDICALLY SIGNIFICANT."

Additional Manufacturer Narrative

REPORTER'S CAUSALITY ASSESSMENT: THE RASH GENERALISED WAS POSSIBLY RELATED TO 13C-UREA.