BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE

    MDR report key: 3702711 · Received March 14, 2014

    Report

    Report Number
    1718912-2014-00002
    Event Type
    Other
    Date Received
    March 14, 2014
    Report Date
    March 12, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHE STATED THAT SHE HAS SORES IN HER ESOPHAGUS THAT MAY BE PRECANCEROUS. SHE STATED THAT IT IS PEPPERMINT THAT CAUSE HER PROBLEMS. SHE STATED THAT IT IS NOT ONLY BIOTENE ORAL RINSE THAT HAS CAUSED HER PROBLEMS BUT ALSO DIFFERENT FOODS OR THINGS THAT HAVE PEPPERMINT IN THEM. SHE REPORTED THAT HER DOCTORS' DID NOT RELATE THE USE OF BIOTENE ORAL RINSE TO WHAT SHE IS EXPERIENCING. SHE REPORTED THAT SHE JUST STARTED USING BIOTENE MOUTH SPRAY, AND SHE HAD A FLARE-UP THIS MORNING ((B)(6) 2014) OF ACID COMING INTO HER THROAT. SHE STATED THAT SHE BELIEVES THAT THE FLARE-UP SYMPTOMS HAVE RESOLVED. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH ORAL MOISTURISERS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE UPSET STOMACH WAS RESOLVED AND THE OUTCOME OF ALL OTHER EVENTS WAS UNKNOWN. THE MANUFACTURER REPORT NUMBERS FOR THIS CASE ARE 1718912-2014-00002 AND 1718912-2014-00003. BIOTENE DRY MOUTH ORAL RINSE AND BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) ARE MANUFACTURED IN (B)(4). THE LOT NUMBER FOR BIOTENE DRY MOUTH ORAL RINSE IS 3C20C1 AND THE LOT NUMBER FOR BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) IS U3N141. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BARRETT'S ESOPHAGUS IN A (B)(6) FEMALE PATIENT WHO RECEIVED ORAL MOISTURISERS (BIOTENE DRY MOUTH ORAL RINSE) MOUTHWASH FOR DRY MOUTH. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). CONCURRENT MEDICATIONS INCLUDED UNKNOWN. ON AN UNKNOWN DATE, THE PATIENT STARTED ORAL MOISTURISERS (DENTAL). AT AN UNKNOWN TIME AFTER STARTING ORAL MOISTURISERS, THE PATIENT EXPERIENCED BARRETT'S ESOPHAGUS, PRECANCEROUS LESIONS OF ESOPHAGUS, ESOPHAGEAL ACID REFLUX, ESOPHAGEAL DISORDER AND UPSET STOMACH. THE PATIENT REPORTED THAT SHE HAS USED BIOTENE ORAL RINSE FOR SEVERAL YEARS, AND THE PEPPERMINT IN THE PRODUCT UPSETS HER STOMACH. SHE STATED THAT IT CAUSES PROBLEMS WITH HER ESOPHAGUS AND GIVES HER ACID REFLUX. SHE REPORTED THAT SHE HAD AN "UPPER AND LOWER GI DONE" AND A COLOSCOPY. SHE STATED THAT SHE NOW HAS BARRETT'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154463 BIOTENE DRY MOUTH ORAL RINSE ORAL MOISTURISERS LFD GLAXOSMITHKLINE NA 3C20C1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other