Description of Event or Problem · 1
THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CANCER IN A MALE PT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)) OROMUCOSAL SPRAY FOR AN UNK INDICATION. CO-SUSPECT PRODUCTS INCLUDED DEXTRANASE, GLUCOSE OXIDASE, LACTOPEROXIDASE, LYSOZYME, MUTANASE (BIOTENE PBF ORAL RINSE) MOUTH WASH FOR AN UNK INDICATION AND LACTOPEROX, LACTOFERRIN, LYSOZYME, GLUCOSE OXIDASE, NA MONOFLUOROPHOSPHATE (BIOTENE TOOTHPASTE) TOOTHPASTE FOR AN UNK INDICATION. ON AN UNK DATE, THE PT STARTED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION), BIOTENE PBF ORAL RINSE (DENTAL) AT AN UNK DOSE AND FREQUENCY AND BIOTENE TOOTHPASTE (DENTAL) AT AN UNK DOSE AND FREQUENCY. ON AN UNK DATE, AN UNK TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION), BIOTENE PBF ORAL RINSE AND BIOTENE TOOTHPASTE, THE PT EXPERIENCED CANCER (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNK. THE ACTION TAKEN WITH BIOTENE PBF ORAL RINSE WAS UNK. THE ACTION TAKEN WITH BIOTENE TOOTHPASTE WAS UNK. UN AN UNK DATE, THE OUTCOME OF THE CANCER WAS NOT RECOVERED/NOT RESOLVED. IT WAS UNK IF THE REPORTER CONSIDERED THE CANCER TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION), BIOTENE PBF ORAL RINSE AND BIOTENE TOOTHPASTE. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THE NURSES AT THE NURSING HOME TOLD THE CONSUMER THAT THE PT GOT CANCER FROM USING BIOTENE. SUSPECT MEDICATION #1: BIOTENE PBF ORAL RINSE (DEXTRANASE, GLUCOSE OXIDASE, LACTOPEROXIDASE, LYSOZYME, MUTANASE) MOUTH WASH. SUSPECT MEDICATION #2: BIOTENE TOOTHPASTE (LACTOPEROX, LACTOFERRIN, LYSOZYME, GLUCOSE OXIDASE, NA MONOFLUOROPHOSPHATE) TOOTHPASTE.