THIS REPORT REFERS TO AN (B)(6) YEAR OLD MALE CONSUMER WHO USED COREGA CREAM FOR ABOUT A YEAR AND A HALF. HE STOPPED USING THE PRODUCT ABOUT A YEAR AGO. ACCORDING TO THE REPORTER (CONSUMER'S DAUGHTER), A HCP PERFORMS EVERY MORNING A LARYNGEAL ASPIRATION AND NEBULIZATIONS IN ORDER TO REMOVE REMAINING CREAM IN AIRWAYS. ON (B)(6) 2015, REPORTER INFORMED THAT HER FATHER PRESENTED WITH A LIFE-THREATENING SEIZURE ABOUT A YEAR AGO AND DUE TO THIS SHE DECIDED TO STOP USING THE ADHESIVE CREAM. AFTER THIS, HER FATHER PRESENTED WITH WHEEZING. SHE CONSULTED WITH A OTORHINOLARYNGOLOGIST WHO INFORMED THAT THE AIRWAYS WERE CONGESTED AND INDICATED ASPIRATIONS AND NEBULIZATIONS. REPORTER INFORMED THAT THE ASPIRATED SUBSTANCE IS WHITE AND GELATINOUS. THE HCPS CONSULTED DO NOT RELATE THIS TO THE USE OF THE CREAM. REPORTER ALSO STATED THAT COREGA WAS APPLIED MORE THAN ONE TIME DAILY AND IN A LARGE QUANTITY (ALTHOUGH THIS IS NOT RECOMMENDED IN PRODUCT LABEL). AN ACTION TAKEN FOR THE DEVICE WAS UNKNOWN.
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Patient 1
SEIZURE [SEIZURE]. WHEEZING [WHEEZING]. MALADMINISTRATION [DRUG MALADMINISTRATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SEIZURE IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA) CREAM FOR PRODUCT USED FOR UNKNOWN INDICATION. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED STROKE AND HIP SURGERY (TWO YEARS AGO (UNSPECIFIED). CONCURRENT MEDICAL CONDITIONS INCLUDED SENILE DEMENTIA. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA, THE PATIENT EXPERIENCED SEIZURE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND LIFE THREATENING) AND INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION. ON AN UNKNOWN DATE, THE OUTCOME OF THE SEIZURE AND INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE SEIZURE TO BE RELATED TO COREGA.