BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)

Description of Event or Problem

PARKISON'S DISEASE AGGRAVATED (PARKINSON'S DISEASE AGGRAVATED) SHAKING (TREMOR). CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF PARKINSON'S DISEASE AGGRAVATED IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNK) FOR AN UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED PARKINSON'S DISEASE. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) (DENTAL) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION), THE PATIENT EXPERIENCED PARKINSON'S DISEASE AGGRAVATED (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND TREMOR. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE PARKINSON'S DISEASE AGGRAVATED AND TREMOR WERE UNKNOWN. THE REPORTER CONSIDERED THE PARKINSON'S DISEASE AGGRAVATED AND TREMOR TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). ADDITIONAL DETAILS: CONSUMER REPORTED USING BIOTENE MOUTH SPRAY, AND IT MADE HER PARKINSON'S DISEASE WORSE.