BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT HYPOALLERGENIC

    MDR report key: 1993352 · Received February 5, 2011

    Report

    Report Number
    9681138-2011-00032
    Event Type
    Other
    Date Received
    February 5, 2011
    Date of Event
    January 28, 2010
    Report Date
    February 3, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POLIDENT HYPOALLERGENIC CREAM IS MARKETED UNDER THE BRAND NAME SUPER POLIGRIP FREE IN THE US AND IS MFG IN (B)(4). NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE. POLIDENT MAXIMUM ADHERENCE IS NOT MARKETED IN THE US. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF TINGLING HANDS AND FEET IN A (B)(6) MALE PT WHO USED POLIDENT MAXIMUM ADHERENCE DENTURE ADHESIVE CREAM AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED HEART DISORDER. CONCURRENT MEDICATIONS INCLUDED LYSINE ASPIRIN (KARDEGIC) AND RAMIPRIL (TRIATEC). ON AN UNK DATE, IN 1985, THE PT BEGAN USING POLIDENT MAXIMUM ADHERENCE DENTURE ADHESIVE CREAM TWICE PER DAY FOR 25 YRS. AN UNK TIME LATER, THE PT EXPERIENCED TINGLING HANDS AND FEET, PAIN IN ARMS AND LEGS, UNBALANCE, HAND AND FEET NUMBNESS, WEAKNESS AND LOW LEUKOCYTES RATE. ON (B)(6) 2010, THE PT WENT TO THE HOSP AND HAD A MEDICAL EXAM (THE PT WAITED 7 HRS AT THE HOSP) WITH A NEUROLOGIST. THE PT WAS NOT HOSPITALIZED. BLOOD TEST WAS DONE AND SHOWED LOW RATE OF LEUCOCYTES. ON (B)(6) 2010, BLOOD TESTING (ZINC RATE IN BLOOD) WAS PERFORMED. THE PT WOULD HAVE A MEDICAL EXAM WITH THE NEUROLOGIST ON (B)(6) 2010 AND WITH A CARDIOLOGIST ON (B)(6) 2010. USE OF POLIDENT MAXIMUM ADHERENCE WAS DISCONTINUED PERMANENTLY IN (B)(6) 2010 AND HE BEGAN USING POLIDENT HYPOALLERGENIC NIC ((B)(4)). AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. F/U INFO RECEIVED ON (B)(6) 2010, FROM A PHYSICIAN: IT WAS REPORTED THAT THE PT WAS USING POLIDENT IN LARGE QUANTITIES. THE PT WAS ALSO REPORTED TO HAVE EXPERIENCED MUSCLE WEAKNESS (PREVIOUSLY REPORTED AS WEAKNESS), ANEMIA AND PARESTHESIA. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. F/U RECEIVED (B)(6) 2010, FROM A PHYSICIAN: THE PT USED THE PRODUCT UNTIL (B)(6) 2010. THE PHYSICIAN CONFIRMED THE PREVIOUSLY REPORTED EVENTS. THE EVENTS STARTED ON (B)(6) 2010. THE PHYSICIAN CONSIDERED THE EVENTS TO BE PROBABLY RELATED TO POLIDENT INTAKE. ON (B)(6) 2010, LAB DATA SHOWED THE FOLLOWING RESULTS: ZINC 37.8 UMOL/L (NORMAL RANGE 11 TO 24); CREATININE 55 UMOL/L (NORMAL RANGE 62 TO 106); SODIUM 133 MMOL/L (NORMAL RATE 135 TO 145); ALCALINE RATE (STOCK) 21 MMOL/L (NORMAL RATE 23 TO 29); CALCIC OSMOLARITY 266 MOSM/L (NORMAL RATE 280 TO 320); ALAT 60 U/L (NORMAL 5 TO 50); MYOGLOBINE 17 UG/L (NORMAL RANGE 17 TO 106); LEUCOCYTES 3.29 G/L (NORMAL RATE 4 TO 10); RED CELLS 3.85 T/L (NORMAL RATE 4 TO 5.5); T.C.M.H 32.70 PG (NORMAL RATE 27 TO 32); PLATELETS 6.30 FL (NORMAL RANGE 70 TO 10); POLYNUCLEAR CELLS (ABSOLUTE VALUE) 1.28 G/L (NORMAL RANGE 2.50 TO 7.50). NO FURTHER INFO WAS PROVIDED. F/U INFO RECEIVED ON (B)(4) 2011: THE PT DETAILS UPDATED ((B)(6)). CO-SUSPECT PRODUCT NOW INCLUDED POLIDENT HYPOALLERGENIC. THE PT'S WIFE REPORTED THAT HIS HEALTH WAS NOT GETTING BETTER AND HE WAS HOSPITALIZED SEVERAL TIMES. THE PT STILL EXPERIENCED PAIN WHICH WAS NOT RELIEVED BY THE MEDICINES HE WAS TAKING, WEAKNESS IN THE ARMS AND LEGS, HE WAS NOT ABLE TO STAND A LONG TIME AND GET TIRED QUICKLY WITH A SINGLE EFFORT. DURING HIS HOSPITALIZATION, VARIOUS EXAMS WERE PERFORMED: BLOOD TESTS, SCANNER, MRI, X-RAY, BONE MARROW AND LUMBAR PUNCTURES, NERVES AND MUSCLES BIOPSY. IN (B)(6) 2010, NERVES AND MUSCLES BIOPSY CONCLUDED THAT THE NERVES WERE VERY AFFECTED. SINCE THIS DATE, THE PT WAS TREATED AND HOSPITALIZED IN THE NEUROLOGY UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT HYPOALLERGENIC DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization TRIATEC| KARDEGIC