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Patient 1
ANAPHYLAXIS. SWOLLEN LIPS, TERRIBLE SORE THROAT, BLEEDING GUMS, SWOLLEN UPPER, BREATHLESSNESS, HOARSE VOICE, PRODUCT COMPLAINT. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBED THE OCCURRENCE OF ANAPHYLAXIS IN A FEMALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA) CREAM FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA, THE PATIENT EXPERIENCED ANAPHYLAXIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), LIP SWELLING, SORE THROAT, GINGIVAL BLEEDING, SWELLING, BREATHLESSNESS AND HOARSE VOICE. ON AN UNKNOWN DATE, THE OUTCOME OF THE ANAPHYLAXIS, LIP SWELLING, SORE THROAT, GINGIVAL BLEEDING, SWELLING, BREATHLESSNESS AND HOARSE VOICE WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ANAPHYLAXIS, LIP SWELLING, SORE THROAT, GINGIVAL BLEEDING, SWELLING, BREATHLESSNESS AND HOARSE VOICE TO BE RELATED TO COREGA. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THIS IS AN INITIAL REPORT OF A SPONTANEOUS ADVERSE EVENT COREGA CREAM IN A FEMALE CONSUMER WHO IS ALSO A HEALTH CARE PROFESSIONAL, WITH INITIALS CBT. SHE REPORTED THIS OCCURRENCE TO THE GSK CALL CENTER. SHE HAS REPORTED THAT FOR A LONG TIME SHE USED THE COREGA POWDER HOWEVER DUE TO CURRENT STOCK-OUTS IN THE LOCAL MARKET SHE STARTED USING COREGA CREAM (DATES NOT SPECIFIED). SHE REPORTED THAT SHE EXPERIENCED ANAPHYLAXIS, WITH THE FOLLOWING EVENTS: SWOLLEN LIPS, A SWOLLEN UPPER PALATE, BREATHLESSNESS, BLEEDING GUMS, TERRIBLE SORE THROAT AND A HOARSE VOICE. THE LOT NUMBER FOR THE PRODUCT IS V14081. FOLLOW-UP WAS CONDUCTED AND THIS IS ALL THE INFORMATION THAT WAS GATHERED FROM THE REPORTER. FOLLOW UP INFORMATION RECEIVED ON 12 FEBRUARY 2015: QA ANALYSIS REVEALED THE COMPLAINT TO BE UNSUBSTANTIATED.