BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE

    MDR report key: 3060456 · Received April 11, 2013

    Report

    Report Number
    1718912-2013-00003
    Event Type
    Other
    Date Received
    April 11, 2013
    Report Date
    April 10, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BIOTENE DRY MOUTH ORAL RINSE IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBED THE OCCURRENCE OF SWOLLEN TONGUE IN A (B)(6) FEMALE PATIENT WHO RECEIVED DEXTRAN, GLUCOSEOX, LACTOPEROX, LYSOZYME, MUTAN, NAMONOFLUOROPHOSPHATE (BIOTENE PBF TOOTHPASTE) FOR AN UNKNOWN DRUG INDICATION. CO-SUSPECT MEDICATION INCLUDED GLUCOSE OXIDASE, LACTOFERRIN, LACTOPEROXIDASE, LYSOZYME (BIOTENE ORALBALANCE GEL) AND GLUCOSE OXIDASE, LACTOPEROXIDASE, LYSOZYME (BIOTENE DRY MOUTH ORAL RINSE). CONCURRENT MEDICATIONS INCLUDED BLOOD PRESSURE MEDICATION (BLOOD PRESSURE MED). ON AN UNKNOWN DATE, THE PATIENT STARTED DEXTRAN, GLUCOSEOX, LACTOPEROX, LYSOZYME, MUTAN, NAMONOFLUOROPHOSPHATE, GLUCOSE OXIDASE, LACTOFERRIN, LACTOPEROXIDASE, LYSOZYME AND GLUCOSE OXIDASE, LACTOPEROXIDASE, LYSOZYME. AT AN UNKNOWN TIME AFTER STARTING DEXTRAN, GLUCOSEOX, LACTOPEROX, LYSOZYME, MUTAN, NAMONOFLUOROPHOSPHATE, GLUCOSE OXIDASE, LACTOFERRIN, LACTOPEROXIDASE, LYSOZYME AND GLUCOSE OXIDASE, LACTOPEROXIDASE, LYSOZYME, THE PATIENT EXPERIENCED SWOLLEN TONGUE, ALLERGIC REACTION, MOUTH PAIN, TONGUE IRRITATION AND DRY TONGUE. THE PATIENT WAS HOSPITALISED. THE PATIENT WAS TREATED WITH STEROID (STEROIDS), "CAPHOSOL", ANTIBIOTICS (UNKNOWN ANTIBIOTICS), "EPISIL" AND STEROID. TREATMENT WITH DEXTRAN, GLUCOSEOX, LACTOPEROX, LYSOZYME, MUTAN, NAMONOFLUOROPHOSPHATE, GLUCOSE OXIDASE, LACTOFERRIN, LACTOPEROXIDASE, LYSOZYME AND GLUCOSE OXIDASE, LACTOPEROXIDASE, LYSOZYME WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CONSUMER'S VISITING NURSE REPORTED THAT CONSUMER WAS HOSPITALIZED FOR SWELLING OF THE TONGUE AND POSSIBLE ALLERGIC REACTION ON (B)(6) 2013 AND WAS TREATED WITH STEROIDS AFTER CONSUMER HAD BEEN USING BIOTENE PBF TOOTHPASTE AND BIOTENE DRY MOUTH GEL. CONSUMER'S NURSE STATED CONSUMER WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2013. SUBSEQUENT FOLLOW UP WAS RECEIVED (B)(6) 2013 FROM PATIENT. THE PATIENT REPORTED THAT SHE HAS BEEN USING BIOTENE PBF TOOTHPASTE, ORAL RINSE AND ORAL BALANCE MOISTURIZING GEL SINCE SHE HAD DISCOVERED IT. SHE WAS NOT CERTAIN HOW LONG AGO THAT HAD BEEN. SHE REPORTED THAT SHE RECENTLY BEGAN USING THE PRODUCT MORE FREQUENTLY AND THOUGHT THAT MAYBE THAT IS WHAT CAUSED HER TONGUE TO SWELL. SHE STATED THAT SHE BRUSHES HER TEETH THREE TIMES A DAY. THE PATIENT REPORTED THAT SHE HAD BEEN PUTTING BIOTENE ORAL BALANCE GEL ON HER TONGUE AND THE ROOF OF HER MOUTH, THEN HER TONGUE BEGAN TO SWELL AND THAT SCARED HER. SHE WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2013 FOR SWELLING OF HER TONGUE. SHE REPORTED THAT SHE HAD BLOOD TESTS DONE ON HER IN THE HOSPITAL BUT WAS NOT TOLD WHAT THE BLOOD TESTS WERE FOR. THE PATIENT WAS DISCHARGE ON (B)(6) 2013 WITH A PRESCRIPTION FOR EPISIL. CONSUMER REPORTED THAT HER MOUTH ALSO HURTS. SHE IS NOT CERTAIN IF HER MOUTH HURTS FROM USING BIOTENE OR BECAUSE OF HER DRY MOUTH. SHE STATED THAT SHE NEVER HAD AN ALLERGY LIKE THIS BEFORE THAT HAD CAUSED THAT TYPE OF REACTION IN HER MOUTH. SHE STATED THAT THE DOCTORS DID NOT KNOW IF IT WAS RELATED TO THE USE OF BIOTENE. SHE STATED THAT THEY WOULD NOT TELL HER ANYTHING. SHE DID NOT KNOW WHAT HER DIAGNOSIS WAS NOR DID SHE RECEIVE ANY DISCHARGE PAPERS. SHE DOES HAVE A FOLLOW UP SCHEDULED WITH A DOCTOR TOMORROW THAT SHE HAS NEVER SEEN BEFORE. SHE ALSO REPORTED THAT HER DOCTOR DID NOT KNOW THAT SHE WAS USING BIOTENE FOR DRY MOUTH. CONSUMER REPORTED THAT HER TONGUE IS NOT SWELLED ANYMORE BUT IT IS DRY AND IRRITATED. SHE STATED THAT HER MOUTH STILL HURTS. IT IS UNKNOWN IF SHE IS EXPERIENCING AN ALLERGIC REACTION. IT WAS NOT CONFIRMED WITH THE PATIENT IF SHE HAD STOPPED USING THE PRODUCT THOUGH THE NURSE HAD REPORTED THAT THE PATIENT HAD DISCONTINUED THE PRODUCT AT THE TIME OF HER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154608 BIOTENE DRY MOUTH ORAL RINSE GLUCOSE OXIDASE + LACTOPEROXIDASE + LYSO LFD GLAXOSMITHKLINE NA 2D26C1

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization BLOOD PRESSURE MED