Description of Event or Problem · 1
THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ANEMIA IN A MALE PT WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (POLIGRIP EX, (B)(4)) FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED NEW POLIGRIP SG (FORMULATION UNK). ON AN UNK DATE, THE PT STARTED NEW POLIGRIP SG AND AFTER AN UNK TIME, HE DEVELOPED ANEMIA. THE PT THEN SWITCHED TO POLIGRIP EX. ON AN UNK DATE, THE PT SWITCHED BACK TO USING NEW POLIGRIP SG. AT AN UNK TIME AFTER STARTING POLIGRIP SG AND POLIGRIP EX, THE PT DEVELOPED BRACHIALGIA, NUMBNESS OF UPPER EXTREMITIES, ARM NUMBNESS AND A SLIGHTLY PAINFUL FEELING IN THE ARMS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. FOLLOW-UP INFO RECEIVED ON (B)(6) 2010: THIS CASE CONCERNS A (B)(6) MALE PT. IN (B)(6) 2007, THE PT STARTED POLIGRIP EX AT LESS THAN 3 CM A DAY TWICE DAILY. IT WAS REPORTED THAT THE PT EXPERIENCED ANEMIA BEFORE HE STARTED USING POLIGRIP EX, IT WAS REPORTED THAT ON AN UNK DATE, AFTER USING POLIGRIP EX, THE PT FELT NUMBNESS IN THE ARM. TREATMENT WITH POLIGRIP EX WAS DISCONTINUED ON (B)(6) 2010 AND SWITCHED BACK TO POLIGRIP SG. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNRESOLVED. POLIGRIP IS MFG IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THE PRODUCT IS AVAILABLE. (B)(4).