BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTHWASH (2013 FORMULATION)

    MDR report key: 8066544 · Received November 13, 2018

    Report

    Report Number
    9615332-2018-00167
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 16, 2018
    Report Date
    November 5, 2018
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE MOUTHWASH (2013 FORMULATION).

    Description of Event or Problem · 1

    STROKE (CEREBROVASCULAR ACCIDENT) [STROKE]. INCREASED LEVEL OF CONFUSION [CONFUSION]. DISORIENTATION [DISORIENTATION]. SPEECH DIFFICULTIES [SPEECH DISORDER]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A PHARMACIST VIA OTHER MANUFACTURER AND DESCRIBED THE OCCURRENCE OF STROKE IN A (B)(6) MALE PATIENT WHO RECEIVED CALCIUM CARBONATE (TUMS) UNKNOWN FOR GASTROINTESTINAL DISORDER. CO-SUSPECT PRODUCTS INCLUDED GLYCERIN (BIOTENE MOUTHWASH (2013 FORMULATION)) MOUTH WASH FOR PRODUCT USED FOR UNKNOWN INDICATION, DEXAMETHASONE TABLET FOR PRODUCT USED FOR UNKNOWN INDICATION, ACETYLSALICYLIC ACID (ASPIRIN) TABLET FOR PRODUCT USED FOR UNKNOWN INDICATION, CYANOCOBALAMIN (VITAMIN B12) TABLET FOR PRODUCT USED FOR UNKNOWN INDICATION, "PANTAPRAZOLE" TABLET FOR PRODUCT USED FOR UNKNOWN INDICATION, LENALIDOMIDE (REVLIMID) FOR MULTIPLE MYELOMA, EPOETIN ALFA FOR PRODUCT USED FOR UNKNOWN INDICATION, LEVOTHYROXINE TABLET FOR AN UNKNOWN INDICATION, FLUDROCORTISONE FOR PRODUCT USED FOR UNKNOWN INDICATION, COLESEVELAM FOR PRODUCT USED FOR UNKNOWN INDICATION, LOPERAMIDE + SIMETHICONE FOR DIARRHEA, PSYLLIUM FOR PRODUCT USED FOR UNKNOWN INDICATION, "COLECALCIFEROL" (VITAMIN D3) TABLET FOR PRODUCT USED FOR UNKNOWN INDICATION, CALCIUM ASCORBATE (ESTER C) FOR PRODUCT USED FOR UNKNOWN INDICATION, DESALINATED SEA WATER, DESALINATED SEA WATER, DESALINATED SEA WATER, DESALINATED SEA WATER (HYDRASENSE) FOR PRODUCT USED FOR UNKNOWN INDICATION AND CLOTRIMAZOLE + HYDROCORTISONE CREAM FOR SCROTAL SWELLING. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED THYROIDECTOMY PARTIAL. CONCURRENT MEDICAL CONDITIONS INCLUDED MULTIPLE MYELOMA, DVT, AMYLOIDOSIS, BLADDER INCONTINENCE, CHRONIC DIARRHEA, RECURRENT URINARY TRACT INFECTION, CLOSTRIDIUM DIFFICILE, ORTHOSTATIC HYPOTENSION, ANEMIA, GASTROINTESTINAL DISORDER, SCROTAL SWELLING AND CONFUSION. ON AN UNKNOWN DATE, THE PATIENT STARTED TUMS AT AN UNKNOWN DOSE AND FREQUENCY AND BIOTENE MOUTHWASH (2013 FORMULATION) (ORAL) AT AN UNKNOWN DOSE (SEE DOSE TEXT). ON (B)(6) 2017, THE PATIENT STARTED DEXAMETHASONE (ORAL) 8 MG (SEE DOSE TEXT) AND ASPIRIN 81 MG ONCE DAILY (81 MG DAILY). ON AN UNKNOWN DATE, THE PATIENT STARTED VITAMIN B12 (ORAL) 1000 G ONCE DAILY (1000 G DAILY). ON (B)(6) 2017, THE PATIENT STARTED PANTAPRAZOLE (ORAL) 40 MG ONCE DAILY (40 MG DAILY). ON (B)(6) 2017, THE PATIENT STARTED REVLIMID (ORAL) 10 MG ONCE DAILY (10 MG DAILY). ON AN UNKNOWN DATE, THE PATIENT STARTED EPOETIN ALFA 40000 AT AN UNKNOWN FREQUENCY, LEVOTHYROXINE (ORAL) 112 MCG ONCE DAILY (112 MCG DAILY) AND FLUDROCORTISONE .1 MG ONCE DAILY (.1 MG DAILY). ON (B)(6) 2018, THE PATIENT STARTED COLESEVELAM 625 MG ONCE DAILY (625 MG DAILY). ON AN UNKNOWN DATE, THE PATIENT STARTED LOPERAMIDE + SIMETHICONE 1 DOSAGE FORM(S) (SEE DOSE TEXT) AND PSYLLIUM AT AN UNKNOWN DOSE (SEE DOSE TEXT). IN (B)(6) 2017, THE PATIENT STARTED VITAMIN D3 1000 IU ONCE DAILY (1000 IU DAILY). ON AN UNKNOWN DATE, THE PATIENT STARTED ESTER C 600 MG ONCE DAILY (600 MG DAILY), HYDRASENSE (OCULAR) AT AN UNKNOWN DOSE ONCE DAILY AND CLOTRIMAZOLE + HYDROCORTISONE AT AN UNKNOWN DOSE (SEE DOSE TEXT). ON (B)(6) 2018, AN UNKNOWN TIME AFTER STARTING TUMS, BIOTENE MOUTHWASH (2013 FORMULATION) AND VITAMIN B12 AND 1 YEAR AND 112 DAYS AFTER STARTING DEXAMETHASONE AND ASPIRIN, THE PATIENT EXPERIENCED STROKE (SERIOUS CRITERIA HOSPITALIZATION, GSK MEDICALLY SIGNIFICANT AND LIFE THREATENING), CONFUSION, DISORIENTATION AND SPEECH DISORDER. THE ACTION TAKEN WITH TUMS WAS UNKNOWN. THE ACTION TAKEN WITH BIOTENE MOUTHWASH (2013 FORMULATION) WAS UNKNOWN. THE ACTION TAKEN WITH DEXAMETHASONE WAS UNKNOWN. THE ACTION TAKEN WITH ASPIRIN WAS UNKNOWN. THE ACTION TAKEN WITH VITAMIN B12 WAS UNKNOWN. THE ACTION TAKEN WITH PANTAPRAZOLE WAS UNKNOWN. REVLIMID WAS INTERRUPTED (DECHALLENGE WAS NEGATIVE). RECHALLENGE WITH REVLIMID WAS UNKNOWN. THE ACTION TAKEN WITH EPOETIN ALFA WAS UNKNOWN. THE ACTION TAKEN WITH LEVOTHYROXINE WAS UNKNOWN. THE ACTION TAKEN WITH FLUDROCORTISONE WAS UNKNOWN. THE ACTION TAKEN WITH COLESEVELAM WAS UNKNOWN. THE ACTION TAKEN WITH LOPERAMIDE + SIMETHICONE WAS UNKNOWN. THE ACTION TAKEN WITH PSYLLIUM WAS UNKNOWN. THE ACTION TAKEN WITH VITAMIN D3 WAS UNKNOWN. THE ACTION TAKEN WITH ESTER C WAS UNKNOWN. THE ACTION TAKEN WITH HYDRASENSE WAS UNKNOWN. THE ACTION TAKEN WITH CLOTRIMAZOLE + HYDROCORTISONE WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE STROKE WAS NOT RECOVERED/NOT RESOLVED AND THE OUTCOME OF THE CONFUSION, DISORIENTATION AND SPEECH DISORDER WERE NOT REPORTED. THE REPORTER CONSIDERED THE STROKE, CONFUSION, DISORIENTATION AND SPEECH DISORDER TO BE RELATED TO TUMS, BIOTENE MOUTHWASH (2013 FORMULATION), DEXAMETHASONE AND ASPIRIN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE STROKE, CONFUSION, DISORIENTATION AND SPEECH DISORDER TO BE RELATED TO VITAMIN B12. ADDITIONAL DETAILS: THE REPORTER CONSIDERED THE STROKE, CONFUSION, DISORIENTATION AND SPEECH DISORDER TO BE RELATED TO REVLIMID. IT WAS THE REPORTER CONSIDERED THE STROKE, CONFUSION, DISORIENTATION AND SPEECH DISORDER TO BE RELATED TO PANTAPRAZOLE TABLET, EPOETIN ALFA , LEVOTHYROXINE TABLET, FLUDROCORTISONE, COLESEVELAM, LOPERAMIDE + SIMETHICONE, PSYLLIUM, COLECALCIFEROL (VITAMIN D3) TABLET, CALCIUM ASCORBATE (ESTER C), HYDRASENSE (SEA WATER), CLOTRIMAZOLE + HYDROCORTISONE CREAM AND MIDODRINE WHICH IS HE WAS USING AS CO SUSPECTS. THERE WERE 18 CO-SUSPECT PRODUCTS AS PER THE STRUCTURED FIELDS. SINCE THE LETTER WAS LIMITED TO 5 CO SUSPECTS. ACTION TAKEN FOR REVLIMID AND EPOETIN ALFA WERE TEMPORARILY INTERRUPTED AND ACTION TAKEN FOR THE OTHER SUSPECT MEDICATIONS WAS NOT PROVIDED (UNKNOWN). THE REPORTER ASSESSED THE CAUSAL RELATIONSHIP SUSPECT MEDICATIONS AND STROKE AS SUSPECTED. INITIAL INFORMATION WAS RECEIVED ON (B)(4) 2018. THE PATIENT HAD MULTIPLE MYELOMA. RELEVANT MEDICAL HISTORY INCLUDED LAMBDA LIGHT CHAIN AMYLOIDOSIS, ORTHOSTATIC HYPOTENSION, PARTIAL THYROIDECTOMY, ANEMIA. ON (B)(6) 2018, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH INCREASED LEVEL OF CONFUSION, SPEECH DIFFICULTIES. A MAGNETIC RESONANCE IMAGING REVELED A STROKE. NO INFECTIOUS CAUSE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904923 BIOTENE MOUTHWASH (2013 FORMULATION) ORAL RINSES LFD KIK CUSTOM PRODUCTS
    904924 DEXAMETHASONE TABLET --- GSK
    904925 ASPIRIN (ACETYLSALICYLIC ACID) TABLET --- GSK
    904926 VITAMIN B12 (CYANOCOBALAMIN) TABLET --- GSK
    904927 PANTOPRAZOLE TABLET --- GSK
    904928 REVLIMID (LENALIDOMIDE) ---
    904929 EPOETIN ALFA ---
    904930 LEVOTHYROXINE ---
    904931 FLUDROCORTISONE ---
    904932 COLESEVELAM ---
    904933 LOPERAMIDE + SIMETHICONE (DIMETICONE, ACTIVATED + LOPERAMIDE) TABLET ---
    904934 PSYLLLIUM ---
    904935 VITAMIN D3 (COLECALCIFEROL) TABLET ---
    904936 ESTER C (CALCIUM ASCORBATE) ---
    904937 HYRASENSE (DESALINATED SEA WATER) ---
    904938 CLOTRIMAZOLE + HYDROCORTISONE ---

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| O