BIOTENE ORAL RINSE

Description of Event or Problem

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF TASTE ABSENT IN A (B)(6) MALE PT WHO RECEIVED GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME (BIOTENE ORAL RINSE) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME. AT AN UNK TIME AFTER STARTING GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXIDASE+LYSOZYME, THE PT EXPERIENCED TASTE ABSENT AND TASTE ALTERATION. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. F/U WAS RECEIVED ON (B)(4) 2012 WHICH UPGRADED THE CASE TO SERIOUS: THE CONSUMER CALLED IN AND REPORTED THE ORIGINALLY REPORTED ADVERSE EVENTS OF LOST SENSE OF TASTE AND ALTERED SENSE OF TASTE AND WAS NOT DUE TO USING THE ORIGINALLY REPORTED PRODUCT OF BIOTENE DRY MOUTH ORAL RINSE. IT WAS DETERMINED WHEN HIS WIFE WHO IS A NURSE WAS CONCERNED IT MAY BE SOMETHING MORE SERIOUS AND HE WENT TO THE HOSP WHERE THEY DID CONFIRM HE WAS HAVING SIGNS OF A STROKE COMING ON.

Additional Manufacturer Narrative

BIOTENE ORAL RINSE IS MFG IN (B)(4), IN THE US, AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).