Description of Event or Problem · 1
BREAST CANCER[BREAST CANCER]. HOT FLASHES [HOT FLASHES]. MORE HOT FLASHES [CONDITION AGGRAVATED]. MEDICATION USED BEYOND EXPIRY DATE [EXPIRED DRUG USED]. THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BREAST CANCER IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED LACTOPEROXIDASE, LYSOZYME (BIOTENE MOUTH SPRAY (ORIGINAL)) UNKNOWN (BATCH NUMBER 2K04C1, EXPIRY DATE 30TH SEPTEMBER 2014) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (ORIGINAL). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (ORIGINAL), THE PATIENT EXPERIENCED BREAST CANCER (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), HOT FLASHES, CONDITION AGGRAVATED AND EXPIRED DRUG USED. BIOTENE MOUTH SPRAY (ORIGINAL) WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). RECHALLENGE WITH BIOTENE MOUTH SPRAY (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE BREAST CANCER, HOT FLASHES AND CONDITION AGGRAVATED WERE RECOVERING/RESOLVING AND THE OUTCOME OF THE EXPIRED DRUG USED WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BREAST CANCER AND HOT FLASHES TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). THE REPORTER CONSIDERED THE CONDITION AGGRAVATED TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). ADVERSE EVENT INFORMATION RECEIVED 8 OCTOBER 2015. CONSUMER REPORTED CONDITION AGGREGATED OF SHE HAD MORE HOT FLASHES AT NIGHT WHILE USING THE PRODUCT. SHE DISCONTINUED USE ABOUT FOUR TO FIVE DAYS AGO AND HER EVENTS HAVE IMPROVED. CONSUMER REPORTED THIS EVENT ON THIS PRODUCT AND UNKNOWN BOTTLES. IN (B)(6) 2015 THIS PATIENT WAS DIAGNOSED WITH HORMONE RELATED BREAST CANCER THAT WAS 100 PERCENT POSITIVE FOR PRER (PROGESTERONE RELATED, ESTROGEN RELATED). THIS REPORT IS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THIS INFORMATION WAS RECEIVED ON 8 OCTOBER 2015 AND IS AS FOLLOWS: THE SUSPECT PRODUCT BIOTENE MOUTH SPRAY (ORIGINAL) WAS RECODED WITH CORRECT FORMULATION OROMUCOSAL SPRAY.