Description of Event or Problem · 1
THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ANEMIA IN A (B)(6) FEMALE PT WHO RECEIVED POLIGRIP EXTRA STRENGTH (B)(4) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTHCARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED CODEINE ALLERGY AND HIGH BLOOD PRESSURE. CONCURRENT MEDICATIONS INCLUDED UNSPECIFIED ANTI-HYPERTENSIVE. ON AN UNK DATE, THE PT STARTED POLIGRIP EXTRA STRENGTH (DENTAL). AT AN UNK TIME AFTER STARTING POLIGRIP EXTRA STRENGTH, THE PT EXPERIENCED ANEMIA, TIREDNESS, FATIGUE, MUSCLE PAIN IN ARM, MUSCLE PAIN IN HAND, BLURRED VISION, DEPRESSION, PAIN IN RIGHT SIDE OF STOMACH AND FREQUENT HEADACHES. THE PT INDICATED SHE WAS OFF WORK FOR THREE MONTHS DUE TO THE DEPRESSION. THE MUSCLE PAIN AFFECTS HER BECAUSE SHE IS UNABLE TO REACH BACKWARDS OR PICK OR PULL STUFF UP. THE BLURRED VISION WAS NOT HELPED BY CHANGING HER CORRECTIVE LENSES TWICE. AN OPTOMETRIST WAS UNABLE TO FIND ANYTHING. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. POLIGRIP EXTRA STRENGTH WAS REDUCED. THE PT'S MUSCLE PAIN WAS TREATED WITH "PHYSIO." AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. MFR'S COMMENT: (SUPER) POLIGRIP IS MFG IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS KNOWN; HOWEVER, IT IS UNK WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).