Description of Event or Problem · 1
DELIRIOUS [DELIRIUM], FELT UNWELL, PAIN ALL OVER [GENERAL BODY PAIN], SEEING THINGS [HALLUCINATION], COULD NOT GET UP [HARD TO AWAKEN]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF DELIRIUM IN A (B)(6) MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)) OROMUCOSAL SPRAY FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED SLEEP APNEA AND CAFFEINE CONSUMPTION (1 CUP OF COFFEE A DAY FOR MANY YEARS). CONCOMITANT PRODUCTS INCLUDED COMPRESSED AIR (CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE)). ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION), THE PATIENT EXPERIENCED DELIRIUM (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), FEELING UNWELL, GENERAL BODY PAIN, HALLUCINATION AND HARD TO AWAKEN. BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). RECHALLENGE WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE DELIRIUM, FEELING UNWELL, GENERAL BODY PAIN, HALLUCINATION AND HARD TO AWAKEN WERE RECOVERED/RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DELIRIUM, FEELING UNWELL, GENERAL BODY PAIN, HALLUCINATION AND HARD TO AWAKEN TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION INCLUDES, THE REPORTER STATED THAT HER FRIEND USED BIOTENE MOISTURIZING MOUTH SPRAY SOMETIME IN (B)(6) 2015 AND THAT HE HAD A BAD REACTION TO IT. THE REPORTER STATED THAT THE CONSUMER WAS IN PAIN ALL OVER AND COULD NOT GET OUT OR MOVE DUE TO THE PAIN. SHE STATED THAT HE FELT LIKE HE WAS GOING TO DIE. IT IS UNKNOWN WHETHER THE CONSUMER WAS A FIRST TIME USER. THE CONSUMER CALLED AND STATED THAT HE HAD A REACTION THE BIOTENE MOISTURIZING MOUTH SPRAY AND THAT HE USED THE PRODUCT DURING THE NIGHT AND WENT BACK TO SLEEP. HE INDICATED THAT WHEN HE WOKE UP, SOMETHING WAS DIFFERENT AND THAT HE DID NOT FEEL WELL. IN THE MORNING HE COULD NOT GET UP OUT OF BED AND STATED THAT HE WAS DELIRIOUS AND SEEING THINGS. THE CONSUMER INDICATED THAT HE USES A CPAP MACHINE WHILE HE SLEEPS AND THAT HE WAS UNSURE OF WHAT MAY HAVE CAUSED THE REACTION. THE CONSUMER SAID IT TOOK OVER A WEEK TO RECOVER AND THAT HE WENT TO SEE A DOCTOR WHO ADVISED THAT THEY DID NOT THINK IT WAS THE BIOTENE MOUTH SPRAY THAT CAUSED THE REACTION. NO TREATMENTS WERE PRESCRIBED.