Description of Event or Problem · 1
HOSPITALIZATION FOR UNKNOWN CAUSE [HOSPITALIZATION], FRACTURED TOE, FOOT BRUISE [CONTUSION OF FOOT], HANDS AND FEET SWOLLEN [PERIPHERAL SWELLING], ANKLES SWOLLEN [ANKLE SWELLING], WATER RETENTION. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF HOSPITALIZATION IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)) OROMUCOSAL SPRAY (BATCH NUMBER (B)(4), EXPIRY DATE 31ST JULY 2016) FOR DRY MOUTH. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NEURODERMATITIS (DURATION 8 MONTHS) AND SHINGLES (DURATION 8 MONTHS). CONCURRENT MEDICAL CONDITIONS INCLUDED DRY MOUTH, SULFONAMIDE ALLERGY AND BACK DISORDER. CONCOMITANT PRODUCTS INCLUDED ESOMEPRAZOLE, OMEPRAZOLE (PRILOSEC), OLANZAPINE (ZYPREXA), TRAMADOL AND MEDICATION UNKNOWN (NUEROSM). IN (B)(6) 2014, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) (DENTAL) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION), THE PATIENT EXPERIENCED HOSPITALIZATION (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT), FRACTURED TOE, CONTUSION OF FOOT, PERIPHERAL SWELLING, ANKLE SWELLING, EYE SWELLING AND WATER RETENTION. BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS CONTINUED WITH NO CHANGE. ON AN UNKNOWN DATE, THE OUTCOME OF THE HOSPITALIZATION WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE FRACTURED TOE, CONTUSION OF FOOT, PERIPHERAL SWELLING, ANKLE SWELLING, EYE SWELLING AND WATER RETENTION WERE RECOVERING/RESOLVING. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE HOSPITALIZATION, FRACTURED TOE, CONTUSION OF FOOT, PERIPHERAL SWELLING, ANKLE SWELLING, EYE SWELLING AND WATER RETENTION TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). ADDITIONAL DETAILS: CONSUMER REPORTED SHE HAS BEEN USING BIOTENE MOUTH SPRAY FOR A WEEK OR SO PRIOR TO REPORT DATE. CONSUMER REPORTED SHE WAS IN THE HOSPITAL FOR FIVE DAYS BUT IT IS UNKNOWN WHEN. WHILE IN THE HOSPITAL, THEY SWITCHED HER FROM PRILOSEC TO ESOMEPRAZOLE. SHE NORMALLY USES A CANE WHEN SHE WALKS BUT WHILE IN THE HOSPITAL THEY GAVE HER A WALKER TO USE. THE WHEELS PROTRUDE FROM THE WALKER. WHEN SHE WAS USING THE WALKER, SHE WENT TO REACH FOR HER MEDICATION, THE WALKER SLID DOWN AND SHE DIDN'T HAVE SHOES ON JUST SOCKS AND THE WALKER WENT ACROSS HER TOES. HER LEFT BIG TOE WAS FRACTURED WHICH IS BETTER NOW AND THE OTHER FOOT WAS A LITTLE BLACK AND BLUE AND SWOLLEN. HER ANKLES WERE SWOLLEN BUT THE RIGHT ANKLE WAS MORE SWOLLEN THAN THE LEFT. CONSUMER REPORTED HER EYES ARE SWOLLEN AND HER HANDS ARE SWOLLEN. SHE HAD TO TAKE OF HER RINGS OFF AND SHE HAS INDENTATIONS IN HER FINGERS. CONSUMER REPORTED HER RIGHT HAND WAS WORSE THAN HER LEFT HAND. HER RIGHT ANKLE SWELLED THE MOST. THE LEFT ANKLE DID NOT SWELL AS FAST AS THE RIGHT ONE. SHE WAS UP ALL NIGHT SOAKING HER FEET IN COLD WATER. SHE HAS BEEN USING ICE PACKS ON HER EYES AND HANDS. HER DOCTOR ADVISED HER TO STOP TAKING ALL OF HER MEDICATION EXCEPT FOR ONE OR TWO WHICH SHE DID NOT SPECIFY. CONSUMER REPORTED EVENTS OF ANKLES SWOLLEN, HANDS SWOLLEN, SWOLLEN EYES AND SKIN INDENTATION CONTINUE BUT HAVE IMPROVED. CONSUMER REPORTED SHE WILL BE (B)(6) YEARS OF AGE IN (B)(6) 2014. CONSUMER REPORTED SHE DOESN'T KNOW IF IT WAS THE BIOTENE THAT CAUSE HER EVENTS OR IF IT WAS FROM THE WALKER GOING ACROSS HER FEET OR IF IT WAS HER MEDICATIONS OF ZYPREXA, TRAMADOL, PRILOSEC AND ESOMEPRAZOLE. CONSUMER ALSO REPORTED SHE MAY BE HAVING WATER RETENTION.