BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 2680871 · Received August 3, 2012

    Report

    Report Number
    3000718406-2012-00003
    Date Received
    August 3, 2012
    Date of Event
    June 16, 2012
    Report Date
    June 21, 2012
    Manufacturer
    OTSUKA AMERICA PHARMACEUTICAL INC.
    Product Code
    MSQ
    PMA / PMN Number
    K014225
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UBIT (13C-UREA) TABLET, 100MG MILLIGRAM(S) UBIT (13C-UREA) TABLET, 100MG MILLIGRAM(2) MSQ OTSUKA AMERICA PHARMACEUTICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other AMLODIN (AMLODIPINE BESILATE) TABLET