POLIDENT DENTURE CLEANSER TABLETS

Description of Event or Problem

THIS CARE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF WATERY DIARRHEA IN A FEMALE PATIENT WHO RECEIVED POLIDENT WHITENING DENTURE CLEANSER TABLET FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ASTHMA, CAFFEINE CONSUMPTION AND HIGH BLOOD PRESSURE. CONCURRENT MEDICATIONS INCLUDED ACEBUTOLO HYDROCHLORIDE (RHOTRAL), RAMIPRIL (ALTACE), AND RIMANTANDINE HYDROCHLORIDE (RIMANTADINE). CO-SUSPECT MEDICATION INCLUDED IRBESARTAN (AVAPRO). IN 2006, THE PATIENT STARTED POLIDENT WHITENING DENTURE CLEANSER. PREVIOUSLY, THE PATIENT RECEIVED POLIDENT 5 MINUTE AND/OR OVERNIGHT OVER A DURATION OF ONE YEAR WITHOUT ANY PROBLEMS. WITHIN 2 DAYS OF STARTING POLIDENT WHITENING DENTURE CLEANSER, THE PATIENT EXPERIENCED WATERY DIARRHEA, SOMETIMES EXPLOSIVE. SHE REPORTED THAT SHE DID NOT HAVE ONE FORMED BOWEL MOVEMENT FOR THE 6 WEEKS SHE USED THE PRODUCT. SHE ASLO EXPERIENCED MILD NAUSEA AND CRAMPING ALONG WITH THE DIARRHEA, BUT NO VOMITING. SHE REPORTED THAT TWICE, SHE DID NOT MAKE IT TO THE BATHROOM APPROXIMATELY TWO WEEKS AFTER THE NAUSEA BEGAN, THE PATIENT VISITED HER PHYSICIAN. BLOOD TESTS INDICATED "SLIGHTLY ELEVATED LIVER LEVELS". STOOL SAMPLES WERE NEGATIVE FOR PARASITES AND BACTERIA. THE PHYSICIAN AND PATIENT CONSIDERED THE CAUSE OF DIARRHEA MIGHT HAVE BEEN AVAPRO WHICH SHE THEN STOPPED TAKING. SHE STOP TAKING ANY OTHER MEDICATIONS THAT WERE THOUGHT TO HAVE BEEN THE CAUSE AND THE EVENTS DID NOT RESOLVE UNTIL SHE SWITCHED BACK TO THE 5-MINUTE POLIDENT. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIDENT WHITENING DENTURE CLEANSER WAS DISCONTIUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED.

Additional Manufacturer Narrative

MFR'S REPORT NUMBER FOR THIS CASE IS 1020379-2006-00005. POLIDENT IS MANUFACTURED IN ANOTHER STATE, AND NEITHER THE LOT NUMBER OR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.