DENTURE CLEANSER

THE RPTR HAS CONTACTED THE MFR ON NUMEROUS OCCASSIONS AND TO DATE HAS REC'D NO RESPONSE. THE RPTR IS NOW CONTACTING THE FDA REGARDING HIS PROBLEM. ACCORDING TO THE RPTR, HE HAS USED POLYDENT DENTURE CLEANSER FOR YEARS WITHOUT ANY PROBLEMS. SINCE HE PURCHASED THE LAST BOX IN MAY, HE HAS BEEN EXPERIENCING GUM TENDERNESS, IRRITATION, AND PAIN WHICH HE ATTRIBUTES TO THE POLYDENT. THE PAIN HAD PROGRESSED TO THE POINT THAT THE RPTR ONLY WORE HIS UPPER AND LOWER PLATES TO EAT. THE RPTR NORMALLY WEARS HIS DENTURES THROUGHOUT THE DAY AND NIGHT. WHEN THE RPTR STOPPED USING THE POLYDENT, HIS SYMPTOMS CEASED IN APPROX. 7-10 DAYS. THE RPTR HAS SOUGHT NO MED ATTENTION.

AN 83 YR OLD FEMALE WITH A HISTORY OF DIABETES MELLITUS, HYPERTENSION, BLINDNESS AND HYPOTHYROIDISM, INGESTED 6 EFFERDENT PLUS TABS ON 12/3/97. SHE WAS TAKEN TO THE HOSP WHERE SHE WAS TREATED WITH ACTIVATED CHARCOAL AND GASTRIC LAVAGE. SHE WAS HEMODYNAMICALLY STABLE, BUT AS A PRECAUTION WAS CARDIAC MONITORED, WITH NO ABNORMALITIES OBSERVED. SERUM CHEMISTRY SHOWED AN INCREASED BUN=25MG/DL AND AN INCREASED CREATININE = 1.2MG/DL. IT WAS NOT DETERMINED IF LAB ABNORMALITIES WERE DUE TO THE INGESTION. Patient WAS ADMITTED FOR HYDRATION AND OBSERVATION. SHE ALSO EXPERIENCED ABDOMINAL DISCOMFORT, WHICH WAS THOUGHT TO BE DUE TO THE GASTRIC LAVAGE AND WAS GIVEN REGLAN. SHE RECOVERED AND WAS DISCHARGED AFTER APPROXIMATELY 36 HRS.

A 64 YEAR OLD MALE CONSUMER WHO HAS AN ALLERGY TO PENICILLIN AND TAKES ATENOLOL FOR HYPERTENSION REPORTED THAT HE HAS USED POLIDENT OVERNIGHT. DENTURE CLEANSER TO CLEAN HIS DENTURE APPROXIMATELY ONCE EVERY WEEK OR ONCE EVERY 2 WEEKS FOR THE PAST 3 YEARS AND HAS EXPERIENCED ANGIO EDEMA, HIVES, THROAT SWELLING, LIP SWELLING, AND PARESTHESIA ON OCCASION OVER THE PAST 2 YEARS. THE CONSUMER REPORTED THAT APPROXIMATELY 15 TO 20 TIMES PER YEAR OVER THE PREVIOUS 2 YEARS HE HAS EXPERIENCED EPISODES OF DIAGNOSED "UNEXPLAINED ANGIO EDEMA." THE CONSUMER REPORTED THAT EACH EPISODE OF ANGIO EDEMA IS VARIABLE AND HAS INVOLVED DIFFERENT BODY SITES AT ONE TIME OR ANOTHER. THE CONSUMER REPORTED THAT THERE IS NO PATTERN TO THE FREQUENCY OF THESE EPISODES AND THAT SOMETIMES HE EXPERIENCES THEM DAYS APART OR WEEKS APART. THE CONSUMER REPORTED THAT HE HAS NEVER CORRELATED POLIDENT OVERNIGHT USE WITH THE ONSET OF ANY OF THESE EPISODES. THE CONSUMER REPORTED THAT A TYPICAL EPISODE STARTS WITH A "TINGLING" SENSATION WHICH LASTS FOR APPROXIMATELY 6 HRS AND IS FOLLOWED BY SWELLING AND HIVES OF THE AFFECTED AREA. THE CONSUMER REPORTED THAT THESE EPISODES HAVE AFFECTED AT ONE TIME OR ANOTHER HIS BACK, ELBOW, FOOT, EAR, AND MOST FREQUENTLY HIS FACE, EYES, LIP, AND TONGUE. THE CONSUMER REPORTED THAT EACH EPISODE TYPICALLY INVOLVES ONE OF THE ABOVE MENTIONED BODY SITES AT A TIME, AND HE DOES NOT EXPERIENCE MULTIPLE-SITE EPISODES. THE CONSUMER REPORTED THAT HIS SWELLING AND HIVES TYPICALLY HAVE RESOLVED IN 1 DAY WITH OR WITHOUT MEDICAL TREATMENT. THE CONSUMER REPORTED THAT HE DID NOT EXPERIENCE ITCHING DURING THESE EPISODES. THE CONSUMER REPORTED THAT HE EXPERIENCED 2 EPISODES OF THROAT SWELLING OVER THE PREVIOUS 2 YEARS. THE CONSUMER REPORTED THAT ON BOTH OCCASIONS THE ENTIRE BACK OF HIS THROAT STARTED TO SWELL, AND APPROXIMATELY 30 MINS LATER HE EXPERIENCED DIFFICULTY BREATHING. THE CONSUMER REPORTED THAT HE SOUGHT TREATMENT AT AN ER BOTH TIMES AND WAS GIVEN INTRAVENOUS BENADRYL, EPINEPHRINE AND PREDINSONE. THE CONSUMER REPORTED THAT HIS THROAT SWELLING RESOLVED APPROXIMATELY 4 HRS AFTER TREATMENT. THE CONSUMER REPORTED THAT HE DID NOT EXPERIENCE TONGUE SWELLING DURING EITHER OF THESE 2 EPISODES. THE CONSUMER REPORTED THAT HE HAD NOT USED POLIDENT OVERNIGHT DIRECTLY PRIOR TO EXPERIENCING HIS THROAT SWELLING IN EITHER OF THESE TWO INSTANCES. THE CONSUMER REPORTED THAT HE HAS SOUGHT MEDICAL TREATMENT FOR ALL OF HIS SYMPTOMS. THE CONSUMER REPORTED THAT HIS PHYSICIAN HAD HIM DOCUMENT ANY FOOD, MEDICATION, OR PRODUCT THAT HE INGESTED OR CAME IN CONTACT WITH, BUT HIS PHYSICIAN HAS BEEN UNABLE TO IDENTIFY A CAUSATIVE FACTOR. THE CONSUMER REPORTED THAT HE HAS NOT CHANGED HIS DIETARY HABITS OVER THE PREVIOUS 2 YEARS. THE CONSUMER REPORTED THAT HIS PHYSICIAN DIAGNOSED HIM WITH "UNEXPLAINED ANGIO EDEMA." THE CONSUMER REPORTED THAT HIS PHYSICIAN REQUESTED A COPY OF THE INGREDIENT LIST FOR POLIDENT OVERNIGHT AND HAS NOT INSTRUCTED THE CONSUMER TO DISCONTINUE PRODUCT USE. THE MFR SUPPLIED A LIST OF POLIDENT OVERNIGHT INGREDIENTS TO THE CONSUMER AND ADVISED THE CONSUMER TO DISCONTINUE PRODUCT USE. THE CONSUMER REPORTED THAT HIS PHYSICIAN REVIEWED THE INGREDIENT LIST AND DID NOT ATTRIBUTE THE CONSUMER'S SYMPTOMS TO PRODUCT USE. THE CONSUMER REPORTED THAT HIS PHYSICIAN PRESCRIBED FOR HIM ZYRTEC SYRUP TO TAKE IN THE EVENT THAT HE EXPERIENCES ANOTHER EPISODE OF ANGIO EDEMA.

NO SAMPLE OF THE PRODUCT WAS RETURNED. THEREFORE, NO ANALYSIS COULD BE CONDUCTED AND IT WAS NOT POSSIBLE TO CONDUCT ADDITIONAL TESTS TO EVALUATE ANY POSSIBLE CONNECTION BETWEEN THE PRODUCT AND THE REPORTED ADVERSE EVENT. DURING 1999 AND 2000 A TOTAL OF 7,400,479 UNITS OF THE PRODUCT WERE SOLD IN THE UNITED STATES. INCLUDING THE SUBJECT EVENT, TWO NOTICES OF REPORTABLE EVENTS OF RELATED PRODUCTS WERE RECEIVED AND REPORTED TO FDA UNDER THE FOLLOWING REPORT NUMBERS 1020379-1999-1 POLIDENT DOUBLE ACTION TABLETS. 1020379-1999-2 POLIDENT BOUBLE OVERNIGHT DENTURE CLEANSER.

NO SAMPLE OF THE PRODUCT WAS RETURNED. THEREFORE, NO ANALYSIS COULD BE CONDUCTED AND IT WAS NOT POSSIBLE TO CONDUCT ADD'L TESTS TO EVALUATE ANY POSSIBLE CONNECTION BETWEEN THE PRODUCT AND THE REPORTED ADVERSE EVENT. DURING THE YEAR 1997 AND 1998 A TOTAL OF 37,276,092 UNITS OF THE PRODUCT WERE SOLD IN THE UNITED STATES. INCLUDING THE SUBJECT EVENT, TWO NOTICES OF REPORTABLE EVENTS FOR RELATED PRODUCTS WERE RECEIVED AND REPORTED TO FDA UNDER THE FOLLOWING REPORT NUMBERS: 1020379-1999-0001 POLIDENT DOUBLE ACTION TABLETS; 1020379-1999-0002 POLIDENT OVERNIGHT DENTURE CLEANSER.

A CONSUMER'S DAUGHTER REPORTED THAT HER 82 YEAR OLD MOTHER WITH NO KNOWN ALLERGIES EXPERIENCED SWELLING OF THE MOUTH, TONGUE, LIPS, AND EXPERIENCED DIFFICULTY BREATHING TEN MINUTES AFTER INSERTING HER DENTURES THAT WERE CLEANED WITH POLIDENT DOUBLE ACTION. THE CONSUMER'S DAUGHTER REPORTED THAT SHE TOOK HER MOTHER TO AN EMERGENCY ROOM WHERE SHE WAS TREATED WITH INTRAVENOUS BENADRYL AND INTRAVENOUS CORTISONE AND DISCHARGED THE SAME DAY WITHOUT MEDICATION. THE CONSUMER'S DAUGHTER REPORTED THAT HER MOTHER HAS EXPERIENCED 5 SIMILAR EPISODES WITHIN THE PAST MONTH; THE 5TH EPISODE OCCURRED 7 DAYS PRIOR. THE CONSUMER'S DAUGHTER REPORTED THAT SHE TOOK HER MOTHER TO THE EMERGENCY ROOM AFTER THE ONSET OF THE FIRST EPISODE AND SHE WAS TREATED WITH INTRAVENOUS BENADRYL AND INTRAVENOUS CORTISONE AND RELEASED THE SAME DAY; THE 2ND THROUGH 5TH EPISODES WERE TREATED AT HOME WITH ORAL BENADRYL. THE CONSUMER'S DAUGHTER ALSO REPORTED THAT HER MOTHER HAS USED POLIDENT DOUBLE ACTION FOR MANY YRS WITHOUT INCIDENT. THE CONSUMER'S DAUGHTER REPORTED THAT WITHIN THE PAST MONTH HER MOTHER HAD NOT CHANGED ANYTHING IN HER DIET, OR TAKEN ANY MEDICATIONS. THE CONSUMER'S DAUGHTER REPORTED THAT AT THE ONSET OF HER FIRST EPISODE OF SYMPTOMS HER MOTHER VISITED AN ALLERGIST AND WAS "TESTED". ON FOLLOW-UP, THE CONSUMER'S ALLERGIST REPORTED THAT THE CONSUMER HAD PRESENTED TO HIM TWICE; ONCE 7 DAYS AFTER SHE WAS DISCHARGED FROM HER FIRST EMERGENCY ROOM VISIT AND THE SECOND TIME FOR A FOLLOW-UP VISIT, THREE WEEKS LATER. THE CONSUMER EXPERIENCED HER SIXTH EPISODE, WHICH REQUIRED HOSPITALIZATION, APPROX ONE WEEK AFTER HER FOLLOW-UP APPOINTMENT WITH THE ALLERGIST. ON FOLLOW-UP APPROX ONE WEEK AFTER THE CONSUMER'S SECOND HOSPITALIZATION, THE ALLERGIST REPORTED THAT THE CONSUMER WAS EXPERIENCING INTERMITTENT FACIAL AND TONGUE SWELLING AND THOUGHT THAT HER SYMPTOMS COULD POSSIBLY BE RELATED TO HER USE OF POLIDENT. THE ALLERGIST INITIALLY THOUGHT THAT THE CONSUMER'S SYMPTOMS WERE RELATED TO HER USE OF CEPHALEXIN, BECAUSE SEVEN DAYS PRIOR TO HER FIRST HOSPITALIZATION SHE HAD USED THE PRODUCT. THE CONSUMER WAS SKIN TESTED WITH DUST MITES, HISTAMINE, CONTROL AND CEPHALEXIN. THERE WAS NO REACTION TO PRICK TESTING WITH CEPHALEXIN, BUT THERE WAS A POSITIVE REACTION TO HISTAMINE AND AN INTRACUTANEOUS TEST WITH DUST MITE WAS SLIGHTLY POSITIVE. THE CONSUMER ALSO HAD A POSITIVE PRICK TEST TO HISTAMINE, BUT WAS NEGATIVE TO FRESH APPLE, G RAPE AND CONTROL. THE CONSUMER WAS TOLD TO AVOID MITES AND TO DISCONTINUE USE OF POLIDENT FOR ONE WEEK AND THEN REINTRODUCE THE PRODUCT. THE ALLERGIST WANTED THE CONSUMER IN FOR AN EVALUATION IN 1 TO 3 WEEKS. ON FOLLOW-UP WITH THE CONSUMER 10 DAYS AFTER HER SECOND HOSPITALIZATION, THE CONSUMER REPORTED THAT SHE HAD DISCONTINUED USE OF POLIDENT FOR APPROX TWO WEEKS AND DURING THAT TIME HAD 3 EPISODES OF FACIAL AND TONGUE SWELLING. NONE OF THE EPISODES REQUIRED HOSPITALIZATION AND SYMPTOMS RESOLVED WITHIN 3 HRS OF ORAL BENADRYL ADMIN. THE CONSUMER REPORTED THAT SHE WENT BACK TO USING POLIDENT AND DURING THE TWO WEEKS THAT SHE HAS BEEN BACK ON THE PRODUCT, SHE HAS NOT HAD ANY EPISODES OF SYMPTOMS. THE CONSUMER REPORTED THAT SHE HAS NOT BEEN BACK TO THE ALLERGIST NOR DOES SHE PLAN TO GO BACK BECAUSE SHE IS FINE. THE CONSUMER REPORTED THAT SHE DOES NOT THINK THAT HER SYMPTOMS WERE DUE TO POLIDENT. NO ADD'L Patient FOLLOW-UP IS REQUIRED.

A CONSUMER REPORTED THAT SHE DEVELOPED LOOSE STOOLS AFTER USING FIXODENT DENTURE ADHESIVE. SHE STATED THAT SHE HAS USED THIS PRODUCT MANY TIMES AND INITIALLY DIDN'T THINK HER REACTION HAD ANYTHING TO DO WITH THE PRODUCT AND USED IT AGAIN. SHE CLAIMS THAT SHE GOT VERY ILL ( FEVER, GASTROINTESTINAL SYMPTOMS) AND IT TOOK SEVERAL DAYS TO RESOLVE. SHE STATES THAT SHE NOTICED THE PRODUCT LOOKED SOMEWHAT GRAY IN COLOR. SHE PURCHASED IT ON 12/26/98.

A PHARMACIST REPORTED THAT A Patient WITH A HISTORY OF MILD SENILE DEMENTIA WAS ADMITTED TO THE HOSP'S INTENSIVE CARE UNIT WITH RESPIRATORY DI STRESS, NECK AND FACIAL SWELLING, RED AND SWOLLEN LIPS AND MOUTH, VOICE HOARSENESS, CONGESTION AND COUGHING AFTER ACCIDENTALLY INGESTING 10-12 POLIDENT 5-MINUTE TABLETS BECAUSE Patient THOUGHT THAT THEY WERE CANDY. A TREATING PHYSICIAN REPORTED THAT ON THE DAY OF ADMISSION THERE WERE "A LOT" OF CRACKLES HEARD IN Patient's CHEST AND Patient HAD A "MARKEDLY" HOARSE VOICE. THE PHYSICIAN REPORTED THAT THE SUSPECTED POSSIBLE ASPIRATION OF THE PRODUCT. A CHEST X-RAY REVEALED A NORMAL HEART AND MEDIASTINUM AND THERE WERE MINIMALLY COARSE MARKINGS SEEN AT BOTH BASES MOST LIKELY DUE TO POOR INSPIRATION. NO ACTIVE INFILTRATE WAS IDENTIFIED. THE PHYSICIAN REPORTED THAT THE HOSP WAS INFORMED BY THE LOCAL POISON CONTROL CENTER THAT THE PRODUCT WAS NOT CAUSTIC, HOWEVER, THE PRODUCT COULD BE IRRITATING. THE PHYSICIAN REPORTED THAT THE Patient's BLOOD WORK WAS NORMAL WITH THE EXPECTION OF A HIGH WHITE-BLOOD CELL COUNT AND THE Patient's BLOOD GASES WERE SATISFACTORY. ONE DAY AFTER ADMISSION, A SECOND PHYSICIAN REPORTED THAT THE Patient's BLOOD PRESSURE WAS 130/70 AND Patient's HEART RATE WAS IRREGULARLY IRREGULAR. THE PHYSICIAN REPORTED THAT AN ECG SHOWED ATRIAL FIBRILLATION DUE TO INTRINSIC AV NODAL DISEASE AND THAT THE PATIENT WAS STARTED ON DIGOXIN AND ASPIRIN THERAPY. THE PHYSICIAN REPORTED THAT A REPEAT CHEST X-RAY SHOWED INCREASING BILATERAL INFILTRATES AND PULMONARY VASCULAR CONGESTION. THE PHYSICIAN REPORTED THAT THE Patient MAY HAVE DEVELOPED ASPIRATION PNEUMONIA AND MAY BE AT RISK OF ADULT RESPIRATORY DI STRESS SYNDROME. THE PHYSICIAN REPORTED THAT THE Patient WAS STARTED ON SOLUMEDROL, BENADRYL, PULMICORT INHALER AND RACEMIC EPINEPHRINE ON AN AS NEEDED BASIS. TWO DAYS AFTER ADMISSION, A THIRD PHYSICIAN REPORTED THAT UPON AUSCULTATION INSPIRATORY CRACKLES AND EXPIRATORY RHONCHI WERE HEARD. THE PHYSICIAN REPORTED THAT CHEST X-RAYS SUGGEST PULMONARY VASCULAR CONGESTION PARTIALLY DUE TO POOR INSPIRATION AND THAT NO DEFINITE PNEUMONIC INFILTRATE OR INFECTION WAS NOTED. THE PHYSICIAN REPORTED THAT THE Patient WAS STILL EXPERIENCING BRONCHOSPASM AND COUGH SECONDARY TO Patient's OVERDOSE AND POSSIBLE ASPIRATION OF THE PRODUCT. THE PHYSICIAN REDUCED THE Patient's DOSAGE OF SOLU-MEDROL AND STARTED THE Patient OF SALBUTAMOL. THE Patient WAS DISCHARGED FROM THE HOSP 12 DAYS AFTER ADMISSION AND IT IS BELIEVED THAT ALL OF THE Patient's SYMPTOMS HAD RESOLVED WITH THE EXCEPTION OF ATRIAL FIBRILLATION.

THE FOLLOWING INFO WAS OBTAINED FROM THE Patient's DISCHARGE SUMMARY: THE Patient WENT INTO AN ACUTE ALKALOTIC METABOLIC STATE AND ASPIRATED SOME GASTRIC CONTENTS AS WELL AS SOME POLIDENT TABLETS. THE Patient WAS SUCTIONED AND TREATED WITH INTRAVENOUS FLUIDS TO TREAT THE ALKALOSIS. THE Patient's DISCHARGE DIAGNOSIS INCLUDED HYPERTENSION. THE Patient's DISCHARGE MEDICATIONS ARE AS FOLLOWS: RAMIPRIL 2.5 MG ONCE DAILY, TAPERING DOSE OF PREDNISONE, FLOVENT 250 MCG 2 PUFFS TWICE DAILY, VENTOLIN 2 PUFFS FOUR TIMES DAILY AS NEEDED, ASPIRIN 325 MG ONCE DAILY, DIGOXIN 0.125 MG ONCE DAILY AND CLINDAMYCIN 300 MG FOUR TIMES DAILY FOR 5 DAYS. BASED ON THE INFO PROVIDED, NO REMEDIAL ACTION REGARDING PRODUCT QUALITY IS REQUIRED.

THE 2002 ANNUAL REPORT OF THE AMERICAN ASSOCIATION OF POISON CONTROL CENTERS (AAPCC) TOXIC EXPOSURE SURVEILLANCE SYSTEM DESCRIBED THE OCCURRENCE OF PROFOUND HYPOTENSION IN A Patient WHO USED DENTURE CLEANSER POWDER, MANUFACTURER UNK. THIS WAS THE ONLY CASE REPORT INVOLVING A DENTURE CLEANSER REPORTED BY THE AAPCC. IT WAS REPORTED THAT THE Patient UNINTENTIONALLY APPLIED THE DENTURE POWDER TO THEIR DENTURES WHILE THEY WERE STILL IN THEIR MOUTH. DURING EVALUATION IN AN EMERGENCY DEPARTMENT, THEY WERE FOUND TO HAVE SEVERE BURNS TO THEIR LIPS, MOUTH AND OROPHARYNX WITH SWELLING AND DROOLING. THEY REQUIRED ENDOTRACHEAL INTUBATION FOR RESPIRATORY DI STRESS SECONDARY TO INCREASED SECRETIONS AND IRRITATION. THEY DEVELOPED PROFOUND HYPOTENSION AND DIED. MANUFACTURER'S COMMENT: GLAXOSMITHKLINE MARKETS A DENTURE CLEANSER POWDER UNDER THE BRAND NAME POLIDENT DENTURE POWER. POLIDENT DENTURE CLEANSER POWDER IS MANUFACTURED IN MEMPHIS, TENNESSEE. THE LOT NUMBER FOR THIS PRODUCT IS NOT AVAILABLE; THEREFORE, QUALITY TESTING WILL NOT BE PERFORMED. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

DURING THE COURSE OF USING THE PRODUCT THE Patient WAS DIAGNOSED WITH A NUMBER OF MEDICAL CONDTIONS BUT THEY COULD NOT REMEMBER THE EXACT DATES OF DIAGNOSIS. IN THE LATE 1980S THEY WERE DIAGNOSED WITH ASTHMA DUE TO A HISTORY OF WHEEZING AND SHORTNESS OF BREATH; THE Patient USES ADVAIR, VENTOLIN, SEREVENT, CLARITIN AND SINGULAIR FOR THE ASTHMA. DURING THIS TIME THEY ALSO EXPERIENCED A GENERALIZED PAIN AND A RHEUMATOLOGIST DIAGONSED THEM WITH FIBROLYALGIA; THEY WERE TREATED WITH HYDROCODONE. IN THE LATE 1980S THE Patient WAS DIAGNOSED WITH HIGH BLOOD PRESSURE FOR WHICH THEY TAKE LASIX. IN THE EARLY 1990S THE Patient WAS DIAGNOSED WITH HIGH CHOLESTEROL FOR WHICH THEY TAKE ZOCOR. DURING THIS TIME ALSO THEY ALSO EXPERIENCED SLEEP DISORDER AND THEY WERE TREATED WITH AMBIEN. IN 2000, THE Patient EXPERIENCED LOWER ABDOMINAL PAIN AND WAS DIAGNOSED WITH IRRITABLE BOWEL SYNDROME; THEY TAKE COLACE FOR THIS CONDITION. THEIR ARTHRITIS AND BACK PROBLEMS CONTINUED TO WORSEN OVER THE YEARS AND THEY WERE DIAGNOSED WITH DEGENERATIVE JOINT DISEASE AND DISC DEGENERATION IN 2003. THEY HAD DIFFICULTY WALKING, PAINFUL JOINTS AND KNEES AND SEVERE MUSCLE CRAMPS FOR WHICH THEY CONTINUE TO TAKE FLEXERIL. THE Patient HAS HAD 9 ARTHROSCOPIC SURGERIES AND IN 2004 HAD BOTH KNEES REPLACED; THEY WERE HOSPITALIZED FOR 5 DAYS AND TREATED WITH PAIN MEDICATIONS (NOS). TREATMENT WITH POLIDENT WAS CONTINUED. ALL OF THE EVENTS ARE UNRESOLVED EXCEPT FOR THE KNEE PAIN WHICH RESOLVED.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DEGENERATIVE JOINT DISEASE IN A Patient WHO USED POLIDENT DENTURE CLEANSER TABLES FOR STAIN DENTURES. THE CONSUMER CALLED WITH A NEW PRODUCT USE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ASPIRIN ALLERGY AND PENICILLIN ALLERGY AND DEPRESSION. CONCURRENT MEDICATIONS INCLUDED DEPAKOTE AND EFFEXOR. SOME TIME IN 1974 THE Patient STARTED USING POLIDENT DENTURE TABLETS. AS A CHILD THEY HAD RHEUMATIC FEVER WHICH DESTROYED ALL THEIR ENAMEL. THEY ALSO HAD ARTHRITIS AND BACK PROBLEMS FOR YEARS DUE TO A FARMING ACCIDENT AS A CHILD. IN 1976 THEY HAD A "LANECTOMY" AND WAS HOSPITALIZED FOR 1 MONTH. IN 1979 THEY WENT TO THE ER AND HAD A SPINAL FUSION PROCEDURE DONE DUE TO A BACK STIFFNESS BROUGHT ON BY HEAVY LIFTING. THE BACK PAIN IS STILL PRESENT AND THEY TREAT IT WITH BEXTRA. THE Patient ALSO REPORTED ONGOING DEPRESSION SINCE THE EARLY 1960S AND THEY USE DEPAKOTE AND EFFEXOR FOR THIS CONDITION. NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. NO CORRECTIVE ACTIONS HAVE BEEN REQUESTED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER'S SPOUSE AND DESCRIBED THE OCCURRENCE OF PROSTATE CANCER IN A Patient WHO USED POLIDENT (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) FOR DENTAL CLEANING. THE CONSUMER'S SPOUSE CONTACTED THE MFR REGARDING A PRODUCT QUALITY COMPLAINT. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, ABOUT TEN YEARS AGO, THE Patient STARTED USING POLIDENT (DENTAL). IN 2001, THE Patient EXPERIENCED DIFFICULTY URINATING AND WAS SUBSEQUENTLY DIAGNOSED WITH PROSTATE CANCER. THE Patient WAS TREATED WITH VARIOUS PROSTATE MEDICATIONS (UNSPECIFIED) AND TWO CANCER CHEMOTHERAPY TREATMENTS, WHICH THEY DID NOT TOLERATE WELL. TREATMENT WITH POLIDENT WAS CONTINUED. THE Patient DIED IN 2004 DUE TO THE PROSTATE CANCER. AN AUTOPSY WAS NOT PERFORMED.

A CONSUMER'S NEIGHBOR DESCRIBED THE OCCURRENCE OF BONE CANCER IN A Patient WHO USED POLIDENT (POLIDENT DENTURE CLEANSER TABLETS) FOR DENTAL CLEANING. THE CONSUMER'S NEIGHBOR CONTACTED THE MFR TO PRAISE THE PRODUCT. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ON AN UNK DATE, THE Patient STARTED POLIDENT (DENTAL), AT AN UNK DOSING. AT AN UNK TIME AFTER STARTING POLIDENT, THE Patient FELL AND WAS DIAGNOSED WITH BONE CANCER. THE Patient WAS TREATED WITH CANCER CHEMOTHERAPY. THE Patient WAS HOSPITALIZED SOME TIME IN 2004, HAD CONTINUED TO USE POLIDENT AND DIED IN 9/2004. THE CAUSE OF DEATH IS UNK. IT IS UNK WHETHER AN AUTOPSY WAS PERFORMED.

THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE AND QUALITY TESTING IS PENDING.

NEITHER THE LOT NUMBER NOR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

A CONSUMER'S NEIGHBOR DESCRIBED THE OCCURRENCE OF BONE CANCER IN A Patient WHO USED POLIDENT (POLIDENT DENTURE CLEANSER TABLETS) FOR DENTAL CLEANING. THE CONSUMER'S NEIGHBOR CONTACTED THE MFR TO PRAISE THE PRODUCT. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ON AN UNK DATE, THE Patient STARTED POLIDENT (DENTAL), AT AN UNK DOSING. AT AN UNK TIME AFTER STARTING POLIDENT, THE Patient FELL AND WAS DIAGNOSED WITH BONE CANCER. THE Patient WAS TREATED WITH CANCER CHEMOTHERAPY. THE Patient WAS HOSPITALIZED SOME TIME IN 2004, HAD CONTINUED TO USE POLIDENT AND DIED IN 9/2004. THE CAUSE OF DEATH IS UNK. IT IS UNK WHETHER AN AUTOPSY WAS PERFORMED.

HEART ATTACK IN A PATIENT WHO RECEIVED POLIDENT (POLIDENT DENTURE CLEANSER TABLETS) FOR DENTAL CARE. THE CALLER INITIALLY CALLED TO ASK ABOUT PRODUCT AVAILABILITY FOR THEMSELVES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, Patient STARTED POLIDENT (DENTAL). IN 1992 Patient EXPERIENCED A HEART ATTACK. AN AMBULANCE CAME BUT THE PATIENT HAD ALREADY DIED; THEY WERE NOT HOSPITALIZED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. THE CONSUMER'S FAMILY MEMBER REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF LEG FRACTURE IN A Patient WHO RECEIVED POLIDENT (POLIMENT OVERNIGHT DENTURE CLEANSER TABLETS) FOR DENTAL CLEANING. THE CONSUMER INITIALLY CALLED WITH A PRODUCT USE QUESTION. A PHYSICIAN OR OTHER HEATH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGY TO TAGAMET, DIABETES, HYPERTENSION, PENICILLIN ALLERGY AND SULFA ALLERGY. CONCURRENT MEDICATIONS INCLUDED DIOVAN, NORVASC AND MONOPRIL. ON AN UNK DATE, THE Patient STARTED POLIDENT (DENTAL). IN 2003, THE Patient FELL AND FRACTURED THEIR LEG; THEY WERE HOSPITALIZED AND UNDERWENT KNEE REPAIR SURGERY IN NOV 2004. TREATMENT WITH POLIDENT WAS CONTINUED. THE EVENTS RESOLVED. MFR'S COMMENT POLIDENT IS MANUFACTURED IN MEMPHIS, TENNESSEE AND NEITHER THE PRODUCT NOR LOT NUMBER OF FOR THIS PRODUCT IS AVAILABLE.

NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF RECURRENT CONGESTIVE HEART FAILURE IN A Patient WHO RECEIVED POLIDENT TABLET FOR DENTURES. THEY CALLED REGARDING A PRODUCT PACKAGING COMPLAINT. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE Patient's PAST MEDICAL HISTORY INCLUDED CONGESTIVE HEART FAILURE, HEART ATTACK, HYPERTENSION, PENICILLIN ALLERGY, SULFA ALLERGY AND TYLENOL #3 ALLERGY. CONCURRENT MEDICATIONS INCLUDED LASIX. OVER 10 YEARS AGO, THE Patient STARTED POLIDENT (DENTAL). THEY REPORTED BEING HOSPITLAIZED 100 TO 110 TIMES OVER THE LAST 10 YEARS FOR RECURRENT CONGESTIVE HEART FAILURE. IN 1997, THEY UNDERWENT "RADICAL HEART SURGERY" FOR AN UNSPECIFIED HEART VALVE PROBLEM. THEY WERE TREATED WITH WARFARIN SODIUM (COUMADIN). IN 2002, THEY WERE TOLD THEY HAD EARLY CATARACT AND IN 2003 EXPERIENCED DECREASED VISION AND HAS BEEN TREATED WITH AN EYE WASH. IN 2004, THEY WERE DIAGNOSED WITH NEW ONSET DIABETES AND TREATED WITH METFORMIN HYDROCHLORIDE (GLUCOPHAGE). TREATMENT WITH POLIDENT CONTINUED. THE EVENTS ARE UNRESOLVED.

NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CORONER AND DESCRIBED THE OCCURRENCE OF INTOXICATION IN A CONSUMER WHO INGESTED PERLODENT MED TABS. ON AN UNKNOWN DATE THE CONSUMER INGESTED AN UNKNOWN AMOUNT OF PERLODENT MED TABS (NEARLY "ONE PACK"), WHICH WAS PROVIDED BY ANOTHER PERSON. CONSUMER WAS ADMITTED TO HOSPITAL AND DIED TWO DAYS LATER, FOLLOWING INGESTION OF THE MEDICAL DEVICE. AN AUTOPSY IS TO BE PERFORMED. FOLLOW-UP INFORMATION RECEIVED VIA A TELEPHONE CALL FROM THE CORONER IN APRIL 2004. THE CORONER REPORTED THAT THE Patient DIED DUE TO "ASPIRATION OF THE SUBSTANCE INTO THE LUNGS", AND THAT THE EVENT WAS DEFINITELY RELATED TO THE WRONG ROUTE OF ADMINISTRATION OF THE PRODUCT. PERLODENT TABLETS, MANUFACTURED BY GLAXOSMITHKLINE, HAS BEEN IDENTIFIED AS THE SUSPECT PRODUCT IN THIS CASE. PERLODENT IS MANUFACTURED IN DUNGARVEN, IRELAND. THE LOT NUMBER NOR PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

IN 2005 THE Patient ACCIDENTALLY INGESTED PART OF A POLIDENT (DENTAL) TABLET AFTER MISTAKING IT FOR A PIECE OF HARD TACK CANDY AND THE Patient EXPERIENCED FEELING UNWELL, VOMITING FOR 30 MINUTES, THROAT BURNING, REGURGITATION AFTER DRINKING WATER, AND DIFFICULTY TALKING FOR LONG PERIODS DUE TO THE THROAT BURNING. THE Patient WAS ADMITTED TO THE HOSP THE NEXT DAY AND EXPERIENCED AN ELEVATED BLOOD PRESSURE, A RISE IN TEMPERATURE, THEIR THROAT WAS RAW, THEIR VOICE RASPY AND Patient HAD DIFFICULTY EATING. THE Patient WAS DIAGNOSED WITH AN UNSPECIFIED PNEUMONIA AND TREATED WITH INTRAVENOUS ANTIBIOTICS, POTASSIUM SALT (POTASSIUM) AND A LIQUID DIET. THE Patient WAS DISCHARGED ON 22 APRIL 2005 AND WAS GIVEN NO DISCHARGE MEDICATIONS OR INSTRUCTION. THE Patient's ELEVATION IN BLOOD PRESSURE AND TEMPERATURE, THROAT BURNING FEELING, THROAT RAWNESS, REGURGITATION AND DIFFICULTY EATING HAVE RESOLVED. THE Patient VOICE REMAINS RASPY AND THE Patient REPORTED THAT THE PHYSICIAN STATED HIS VOICE COULD REMAIN RASPY FOR MONTHS.

PRODUCT EVALUATION SUMMARY: THE SUBMITTED SAMPLE MET THE SPECIFICATIONS FOR RELEASE. TESING INCLUDED: ODOR CONFORMS (SPEC MINTY) DISINTEGRATION TIME 14 MINUTES (SPEC 15 MIN. MACIMUM) PH 9.3 (SPEC 8.9-9.9) OXYGEN CONTENT 2.9% (SPEC 2.4% MINIUMU) SOLUTION COLOR CONFORMS (SPEC. BLUE, FADING) NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

FOLLOW-UP INFO WAD RECEIVED IN 2005 IN THE FORM OF MED RECORDS. THE Patient INDERWENT AN ESOPHAGO GASTRODUODENOSCOPY IN 2005 DUE TO COMPLAINTS OF DYSPHAGIA. Patient WAS DIAGNOSED WITH A GASTRIC POLYP AND UNDERWENT A POLYPECTOMY AND SEVERELY ULCERATED MUCOSA UNDER THE EPIGLOTTIS WAS NOTED. A MODERATE SIZE HIATAL HERMIA WAS NOTED AND NO HELICOBACTER PYLORI WAS NOTED. THE Patient WAS TREATED WITH PROTONIX. HE WAS ALSO DIAGNOSED WITH SEVERE INFLAMMATION OF THE POSTERIOR PHARYNX ND VOCAL CORDS AND WAS REFERRED TO SEE AN ENT SPECIALIST. ACCIDENTAL EXPOSURE, DRUG ADMINISTRATION ERROR, PHEUMONIA, VOMITING, THROAT IRRITATION, REGURGITATION OF FOOD, SPEECH DISORDER, MALAISE, BLOOD PRESSURE INCREASED, BODY TEMPERTURE INCREASED, PHARYNGOLARYNGEAL PAIN, DYSPHONIA, EATING DISORDER, HIATUS HERNIA, DYSPHAGIA, GASTRIC POLYPS, PHARYNGITIS, VOCAL CORD INFLAMMATION, ULCERATIVE LESION.

FOLLOW UP INFORMATION WAS RECEIVED IN 2005 IN THE FORM MEDICAL RECORDS. THE PATIENT UNDERWENT ESOPHAGO GASTRODUODENOSCOPY IN 2005, DUE TO COMPLAINTS OF DYSPHAGIA. THE PATIENT WAS DIAGNOSED WITH GASTRIC POLYPOP AND UNDERWENT A POLYPECTOMY AND SEVERELY ULCERETED MUCOSA UNDER THE EPIGLOTIS WAS NOTED. A MODERATE SIZE HISTAL HERNIA WAS NOTEDE AND NO HELICOBACTER PYLORI WAS NOTED. THE PATIENT WAS TREATED WITH PROTINIX. THE PATIENT WAS ALSO DIAGNOSED WITH SEVERE INFLAMMATION OF THE POSTERIOR PHARYNX AND VOCAL CHORDS AND WAS REFERRED TO SEE AN ENT SPECIALIST.

THROAT IRRITATION, REGURATION OF FOOD, SPEEHK DISORDER, MALAISE, BLOOD PRESSURE INCREASED, BODY TEMPERATURE INCREASED, PHARYNGOLARYNGEAL PAIN, DYSPHONIA, HATING DISORDER, HAITUS HERNIA, DYSPHAGIA, GASTRIC POLYPE, PHARYNGITIS, VOCAL CORD INFLAMMATION, ULCERATIVE LESION.

PT REPORTED THAT Patient IS " SWEATING IT OUT" BECAUSE THEIR DOCTORS INFORMED THEM THAT IT WOULD BE ANOTHER MONTH BEFORE Patient GETS THEIR VOICE BACK, ALTHOUGH THE CONSUMER WAS ABLE TO SPEAK. ALTHOUGH THE CONSUMER CONSENTED TO PROVIDE MEDICAL RECORDS, NONE HAVE BEEN RECEIVED.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CONGESTIVE HEART FAILURE IN A Patient WHO USED POLIDENT (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TO CLEAN THEIR DENTURES. THE CONSUMER INITIALLY CALLED TO REPORT THEIR NON-SERIOUS EVENTS WITH POLIDENT FOR PARTIALS. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE Patient's PAST MEDICAL HISTORY INCLUDED OSTEO ARTHRITIS AND A FAMILY HISTORY OF CONGESTIVE HEART FAILURE. APPROX 20 YEARS AGO, THE Patient STARTED USING POLIDENT OVERNIGHT (DENTAL) AND WAS HOSPITALIZED AND DIAGNOSED WITH CONGESTIVE HEART FAILURE. THEY WERE HOSPITALIZED EIGHT MORE TIMES DURING THE 20-YEAR PERIOD THAT THEY USED POLIDENT. THEY CONTINUE TO USE POLIDENT.

FREE SAMPLE OF DENTURE CLEANSER FROM STORE. Patient BROKE DOWN WITH RASH AFTER USE.

THIS CASE WAS REPORTED BY A CONSUMER'S FAMILY MEMBER AND DESCRIBED THE OCCURRENCE OF ASYSTOLE IN A Patient WHO USED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS FOR DENTAL CLEANING. THE CONSUMER CALLED WITH A PRODUCT QUESTION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE Patient STARTED USING POLIDENT DENTURE CLEANSER TABLETS (DENTAL). SOME TIME IN 2003, THE Patient EXPERIENCED LEG INFECTION AND SWELLING. THE Patient WAS TREATED WITH ANTIBIOTICS (NOS) AND OTHER MEDICATIONS (NOS) FROM VISITING NURSES. THE INFECTION CONTINUED TO PROGRESS UP THEIR LEG AND THE Patient ALSO EXPERIENCED ASYSTOLE. FAMILY MEMBER REPORTED THAT THE Patient's "HEART GAVE OUT" AND FAMILY MEMBER DIED IN 2003. TREATMENT WITH POLIDENT WAS CONTINUED UP UNTIL THE TIME OF THEIR DEATH. THE CAUSE OF DEATH IS UNKNOWN AND NO AUTOPSY WAS PEFORMED. THE REPORTER REFUSED TO PROVIDE ADDITIONAL INFORMATION.

THIS CASE WAS REPORTED BY A CONSUMER'S FRIEND AND DESCRIBED THE OCCURRENCE OF DEATH NOS IN A Patient WHO USED POLIDENT (POLIDENT FOR PARTIALS DENTURE CLEANSER TABLETS) FOR DENTAL CLEANING. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. PAST MEDICAL CONDITIONS INCLUDE SMOKING. ON AN UNK DATE, THE Patient STARTED USING POLIDENT (DENTAL). AT AN UNK TIME AFTER STARTING POLIDENT, THE Patient DIED SEVEN TO EIGHT YEARS AGO. THE CAUSE OF DEATH IS UNK. IT IS UNK WHETHER AN AUTOPSY WAS PERFORMED. MFR'S COMMENT: THE MFR'S REPORT NUMBER FOR THIS CASE IS 1020379-2005-00004. POLIDENT FOR PARTIALS DENTURE CLEANSER TABLETS IS MANUFACTURED IN MEMPHIS, TENNESSEE AND NEITHER THE LOT NUMBER NOR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ESOPHAGEAL CANCER IN A Patient WHO RECEIVED POLIDENT (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) FOR DENTAL CLEASNING. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE Patient's PAST MEDICAL HISTORY INCLUDED CIGARETTE SMOKER; Patient QUIT IN 1998. IN 1957 THE Patient STARTED POLIDENT (DENTAL). IN THE MID 1990'S Patient WAS DIAGNOSED WITH ESOPHAGEL CANCER AND RECEIVED CHEMOTHERAPY AND HAD SCAR TISSUE REMOVED. THE ESOPHAGEAL CANCER RESOLVED. IN 2000, Patient UNDERWENT REMOVAL OF AN ANEURYSM IN THE PULMONARY ARTERY; THE EVENT RESOLVED IN JAN. 2004, Patient EXPERIENCED TEMPERATURE INCREASED AND TIREDNESS. ON THE 2ND DAY A CHEST X-RAY THAT SHOWED PNEUMONIA. Patient WAS HOSPITALIZED FOR A COUPLE OF WEEKS AND TREATED WITH IV ANTIBIOTICS. AS THE PNEUMONIA WAS RESOLVING, Patient WAS DIAGNOSED WITH INOPERABLE LUNG CANCER AND WAS TREATED WITH CHEMOTHERAPY AND RADIOTHERAPY. THE CANCER THEN METASTASIZED TO THEIR BRAIN. Patient ALSO EXPERIENCED WEIGHT LOSS. TREATMENT WITH POLIDENT WAS CONTINUED. THE CONSUMER DIED IN JULY 2004.

AT THE TIME OF THIS REPORT, THE LOT NUMBER FOR THIS PRODUCT WAS NOT PROVIDED AND QUALITY TESTING IS PENDING THE RETURN OF THE PRODUCT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF GLAUCOMA IN A Patient WHO RECEIVED POLIDENT FOR DENTURE CLEANING. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. ON AN UNK DATE, THE Patient STARTED POLIDENT (DENTAL). ABOUT TWO AND A HALF YEARS AGO, Patient WAS DIAGNOSED WITH GLAUCOMA; ABOUT ONE YEAR AGO Patient EXPERIENCED DIZZINESS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE OUTCOME OF THE EVENTS ARE UNK. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SARCOMA IN A Patient WHO USED POLIDENT FOR DENTAL CLEANING. THE CONSUMER CONTACTED THE MFR REGARDING A PRODUCT COMPLAINT. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDE CIGARETTE SMOKING, DIABETES, HIGH BLOOD PRESSURE AND HIGH CHOLESTEROL. CONCURRENT MEDICATIONS INCLUDED POLIDENT SMOKERS DENTURE CLEANSER TABLETS, LIPITOR, METFORMIN AND METOPROLOL. IN APPROX 1974 THE Patient STARTED USING POLIDENT (DENTAL). IN 2004, THE Patient EXPERIENCED HIP PAIN, UNDERWENT A SPINAL TAP AND WAS DIAGNOSED WTIH SARCOMA OF THE HIP. Patient HAD THE SARCOMA EXCISED IN 2004 AND WAS HOSPITALIZED FOR FIVE DAYS. THE Patient REPORTED THAT Patient DID NOT REQUIRE ANY FURTHER TREATMENTS AND Patient IS FEELING WELL. TREATMENT WITH POLIDENT WAS CONTINUED. THE OUTCOME OF THE EVENTS IS RESOLVED. POLIDENT OVERNIGHT DENTURE CLEANSER IS MFG IN MEMPHIS, TENNESSEE AND NEITHER THE LOT NUMBER OR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SARCOMA IN A Patient WHO USED POLIDENT (POLIDENT SMOKERS DENTURE CLEANSER TABLETS) FOR DENTAL CLEANING. THE CONSUMER CONTACTED THE MANUFACTURER REGARDING A PRODUCT COMPLAINT. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED CIGARETTE SMOKING, DIABETES, HIGH BLOOD PRESSURE AND HIGH CHOLESTEROL. CONCURRENT MEDICATIONS INCLUDED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS, LIPITOR, METFORMIN AND METOPROLOL. IN APPROXIMATELY 1974 THE Patient STARTED USING POLIDENT (DENTAL). IN 2004, THE Patient EXPERIENCED HIP PAIN, UNDERWENT A SPINAL TAP AND WAS DIAGNOSED WITH SACROMA OF THE HIP. THEY HAD THE SARCOMA EXCISED IN 2004 AND WAS HOSPITALIZED FOR FIVE DAYS. THE Patient REPORTED THAT THEY DID NOT REQUIRE ANY FURTHER TREATMENTS AND THEY ARE FEELING WELL. TREATMENT WITH POLIDENT WAS CONTINUED. THE OUTCOME OF THE EVENTS IS RESOLVED.

NEITHER THE LOT NUMBER NOR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF PARKINSON'S DISEASE IN A Patient WHO USED POLIDENT DENTUR CREME TOOTHPASTE FOR LOOSE DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED POLIGRIP FREE DENTURE ADHESIVE CREAM. IN THE FOLLOWING MONTH THE Patient WAS DIAGNOSED WITH PARKINSON'S DISEASE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIDENT DENTU CREME TOOTHPASTE WAS CONTINUED. THE EVENT IS UNRESOLVED. NEITHER THE LOT NUMBER NOR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

PT HAS USED THE PRODUCT TO SOAK BRIDGE IN, IN THE PAST WITHOUT INCIDENT. Patient SOAKED THEM AS USUAL AND ON THIS OCCASION, UPON PLACING THEM BACK IN MOUTH, Patient EXPERIENCED A BURNING OF THE LIPS AND GUMS WHICH LASTED ABOUT 2-3 HOURS, Patient DID NOT SEEK MEDICAL ATTENTION. SENSED A SMELL OF BLEACH TO THE PRODUCT. THE COMPLAINANT MENTIONED THAT WHEN Patient REMOVED THE BRIDGE FROM MOUTH, RPTR LOOKED AT THE GUM LINE AND INSTEAD OF BEING PINK, IT WAS WHITE. CONTACTED POISON CONTROL WHO TOLD Patient THAT THEY SHOULD LOOK OUT FOR BLISTERING. IF THAT DOES NOT OCCUR, Patient SHOULD BE OKAY. COMPLAINANT STATED THAT REGENT LABS, ACCORDING TO THEIR WEBSITE, ALSO MARKETS BLEACHES.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DIFFICULTY WRITING IN A Patient WHO USED POLIDENT (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) FOR DENTAL CARE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED POLIDENT DENTURE CLEANSER TABLETS. IN 2002 THE Patient STARTED USING POLIDENT (DENTAL). IN 2002, THE Patient EXPERIENCED DIFFICULTY WRITING, NEUROLOGICAL PROBLEMS, SLURRED SPEECH, INSTABILITY AND DIZZINESS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIDENT WAS CONTINUED. THE EVENTS ARE UNRESOLVED. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DIFFICULTY WRITING IN A Patient WHO USED POLIDENT (POLIDENT DENTURE CLEANSER TABLETS) FOR DENTAL CARE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. IN 2002 THE Patient STARTED USING POLIDENT (DENTAL). IN 2002, THE Patient EXPERIENCED DIFFICULTY WRITING, NEUROLOGICAL PROBLEMS, SLURRED SPEECH, INSTABILITY AND DIZZINESS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIDENT WAS CONTINUED. THE EVENTS ARE UNRESOLVED. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF A STROKE IN A Patient WHO USED POLIDENT DENTURE CLEANSER TABLETS FOR STAIN DENTURES. THE CONSUMER CALLED WITH A PRODUCT QUESTION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE Patient's PAST MEDICAL HISTORY INCLUDED SMOKING. CONCURRENT MEDICAL CONDITIONS INCLUDED ARTERITIS, HEARTBURN AND HIGH BLOOD PRESSURE. CONCURRENT MEDICATIONS INCLUDED CARDIZEM SR, GLYBURIDE, DETROL LA, PEPCID AND CENTRUM SILVER. IN 1945 THE Patient STARTED USING POLIDENT DENTURE CLEANSER TABLETS. IN 1991, THE Patient EXPERIENCED DOUBLE VISION, LIGHT-HEADEDNESS AND COLLAPSED ACUTELY FALLING DOWN. THEY WERE TAKEN TO THE ER AND DIAGNOSED WITH A STROKE; Patient COULD NOT RECALL THE TREATMETNS. AS A CONSEQUENCE THE Patient WALKS WITH A CANE AND A WALKER ALTERNATIVELY AND HAS LEFT-SIDED PARALYSIS. DURING THEIR 2 WEEK HOSPITALIZATION THE Patient WAS ALSO DIAGNOSED WITH ADULT ONSET DIABETES Patient COULD NOT REMEMBER THEIR INITIAL FASTING BLOOD TREATED WITH INSULIN; CURRENTLY THEIR FBS REMAINS STEADY AT 100MG/DL WITH MEDICATION AND PROPER DIET. WHILE IN THE HOSP THE Patient ALSO HAD THEIR GALL BLADDER REMOVED DUE TO DETERIORATION AND GALL STONES; Patient WAS TREATED WITH POSTOPERATIVE ANALOGESTIC MEDICATIONS. TREATMENT WITH POLIDENT WAS CONTINUED. THE LEFT-SIDED PARALYSIS, DIABETES, CANE AND WHEELCHAIR USE ARE ONGOING; ALL OTHER EVENTS HAVE RESOLVED.

NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

MFR'S REPORT NUMBER FOR THIS CASE IS 1020379-2006-00005. POLIDENT IS MANUFACTURED IN ANOTHER STATE, AND NEITHER THE LOT NUMBER OR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CARE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF WATERY DIARRHEA IN A FEMALE PATIENT WHO RECEIVED POLIDENT WHITENING DENTURE CLEANSER TABLET FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ASTHMA, CAFFEINE CONSUMPTION AND HIGH BLOOD PRESSURE. CONCURRENT MEDICATIONS INCLUDED ACEBUTOLO HYDROCHLORIDE (RHOTRAL), RAMIPRIL (ALTACE), AND RIMANTANDINE HYDROCHLORIDE (RIMANTADINE). CO-SUSPECT MEDICATION INCLUDED IRBESARTAN (AVAPRO). IN 2006, THE PATIENT STARTED POLIDENT WHITENING DENTURE CLEANSER. PREVIOUSLY, THE PATIENT RECEIVED POLIDENT 5 MINUTE AND/OR OVERNIGHT OVER A DURATION OF ONE YEAR WITHOUT ANY PROBLEMS. WITHIN 2 DAYS OF STARTING POLIDENT WHITENING DENTURE CLEANSER, THE PATIENT EXPERIENCED WATERY DIARRHEA, SOMETIMES EXPLOSIVE. SHE REPORTED THAT SHE DID NOT HAVE ONE FORMED BOWEL MOVEMENT FOR THE 6 WEEKS SHE USED THE PRODUCT. SHE ASLO EXPERIENCED MILD NAUSEA AND CRAMPING ALONG WITH THE DIARRHEA, BUT NO VOMITING. SHE REPORTED THAT TWICE, SHE DID NOT MAKE IT TO THE BATHROOM APPROXIMATELY TWO WEEKS AFTER THE NAUSEA BEGAN, THE PATIENT VISITED HER PHYSICIAN. BLOOD TESTS INDICATED "SLIGHTLY ELEVATED LIVER LEVELS". STOOL SAMPLES WERE NEGATIVE FOR PARASITES AND BACTERIA. THE PHYSICIAN AND PATIENT CONSIDERED THE CAUSE OF DIARRHEA MIGHT HAVE BEEN AVAPRO WHICH SHE THEN STOPPED TAKING. SHE STOP TAKING ANY OTHER MEDICATIONS THAT WERE THOUGHT TO HAVE BEEN THE CAUSE AND THE EVENTS DID NOT RESOLVE UNTIL SHE SWITCHED BACK TO THE 5-MINUTE POLIDENT. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIDENT WHITENING DENTURE CLEANSER WAS DISCONTIUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED.

MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 1020379-2006-00004. POLIDENT IS MANUFACTURED AND NEITHER THE LOT NUMBER OR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF VOCAL CORD SWELLING IN A FEMALE PATIENT WHO RECEIVED POLIDENT (POLIDENT FOR PARTIALS DENTURE CLEANSER TABLETS) FOR DENTURE CLEANING. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ACID RE FLUX, DIABETES, ELEVATED CHOLESTEROL AND HYPERTENSION. CONCURRENT MEDICATIONS INCLUDED CANDESARTAN CILEXETIL (ATACAND), GLIMEPIRIDE (AMARYL) AND SODIUM RABEPRAZOLE (ACIPHEX). IN 2006, THE PATIENT STARTED USING POLIDENT FOR PARTIALS. IN THE SAME MONTH, THE PATIENT EXPERIENCED VOCAL CORD SWELLING AND BLOCKED AIRWAY. SHE WAS EXAMINED BY HER PRIMARY CARE PHYSICIAN AND AN EAR-NOSE-THROAT SPECIALIST, WHO BELIEVED THE SYMPTOMS COULD HAVE BEEN ALLERGY RELATED. IT WAS FELT THE EVENTS COULD BE RELATED TO SLEEP APNEA, BUT A DIAGNOSIS HAD NOT BEEN MADE. ALL OF THE PATIENT'S MEDICATIONS WERE STOPPED ON THE FOLLOWING MONTH, AND THEN SHE WAS SCHEDULED FOR FURTHER EVALUATION. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIDENT FOR PARTIALS WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

THE LOT NUMBER FOR THE PRODUCT IS AVAILABLE, BUT THE PRODUCT IS NOT AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SUSPECTED GASTRIC BLEED IN A MALE Patient WHO REC'D POLIDENT (POLIDENT SMOKERS DENTURE CLEANSER TABLETS) TABLET FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE Patient's PAST MEDICAL HISTORY INCLUDED HEADACHE, CO-SUSPECT MEDICATION INCLUDED POLIDENT. IN 1996, THE Patient BEGAN USING POLIDENT. IN 2006, THE Patient SWITCHED TO POLIDENT FOR SMOKERS. HE STATED THAT HE DID NOT WIPE HIS DENTURES OFF PROPERLY AFTER USING THE PRODUCT AND BEFORE INSERTING THEM IN HIS MOUTH (INTENTIONAL MISUSE). THIS HAD CAUSED HIS SKIN TO BECOME IRRITATED AND STINGING IN HIS LIPS. IN 2006, THE Patient EXPERIENCED AN UPSET AND IRRITATED STOMACH, AND STATED THAT HIS STOMACH WAS RUMBLING AND BURNING. HE ALSO EXPERIENCED BLOODY STOOLS, AND THOUGHT THAT HE MIGHT HAVE GASTRIC BLEEDING. THE Patient DID NOT SEEK MEDICAL ATTENTION. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIDENT FOR SMOKERS WAS DISCONTINUED, AND THE EVENTS RESOLVED WITHIN 2 TO 3 DAYS.

THIS CASE WAS REPORTED BY A CONSUMER, AND DESCRIBED THE OCCURENCE OF POSSIBLE ALLERGY IN A FEMALE Patient WHO RECEIVED POLIDENT (POLIDENT DENTURE CLEANSER TABLETS) TABLET OVER A PERIOD OF YEARS FOR DENTAL CLEANING. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED HIGH BLOOD PRESSURE. CO-SUSPECT MED INCLUDED POLIDENT, RANITIDINE AND DIOVAN HCT. CONCURRENT MEDS INCLUDED ASPIRIN. ON AN UNK DATE, THE Patient STARTED POLIDENT. AT AN UNK TIME AFTER STARTING POLIDENT, WHILE AT A DENTAL APPT, THE Patient WAS ADVISED THAT THE ROOF OF HER MOUTH WAS HOT AND SHE HAD DEVELOPED A RASH. SUBSEQUENTLY, TREATMENT WITH POLIDENT DISCONTINUED AND THE EVENTS RESOLVED. THE Patient CONTINUED TO USE POLIDENT INTERMITTENTLY, USUALLY PRIOR TO DENTAL VISITS. IN 2005, THE Patient WAS HOSPITALIZED (DURATION UNK) TO DETERMINE THE CAUSE OF HIVES. SINCE 2005, THE Patient EXPERIENCED HIVES 5 TIMES, USUALLY OCCURRING EVERY 2 TO 4 MONTHS. ADDITIONALLY, THE Patient REPORTED THAT SHE DEVELOPED A COUGH YEARS AGO WHILE USING POLIDENT. POLIDENT AND HE TOLD THERE WAS NO WAY TO TEST FOR THAT. ADDITIONALLY, THE Patient STATED THAT SHE LOST HER JOB DURING THIS TIME, WHICH LED TO HER FEELING DEPRESSED. THE Patient COULD NOT PROVIDE PRODUCT INFO OR LOT CODE BECAUSE SHE NO LONGER HAD THE PRODUCT. NINE MOS LATER POLIDENT WAS REINTRODUCED AND SHE EXPERIENCED FEELING FUNNY AND HAD TINGLING IN HER MOUTH. SHE STATED THAT THE ROOF OF HER MOUTH WAS DRY AND ITCHING, SHE EXPERIENCED RUNNY NOSE, COUGHING AND MOUTH WATERING. THE Patient REPORTED THAT SHE RECEIVED TREATMENT WITH DIPHENDYDRAMINE (BENADRYL), LORATADINE (CLARITIN), AND A WEEK LONG COURSE OF METHYLPREDNISOLONE (MEDROL) AND PREDNISONE. AT AN UNK TIME LATER, THE EVENTS RESOLVED. FIVE MOS LATER, THE Patient RESTARTED POLIDENT AND SUBSEQUENTLY BROKE OUT IN HIVES. THE Patient SELF TREATED WITH BENADRYL. THE Patient CONTINUED TO FEEL "HORRIBLE" AND VISITED HER PHYSICIAN THE SAME DAY. SHE STATED THAT SHE HAD SWOLLEN HANDS, AN ITCHING THROAT AND RUNNY NOSE. WHILE AT THE DR'S OFFICE, SHE FAINTED. THIRTY MINS PRIOR TO THE FAINTING EPISODE, THE Patient HAD TAKEN RANITIDINE (FOR HIVES) ALONG WITH DIOVAN HYDROCHLOROTHIAZIDE. ACCORDING TO THE PT, HER PHYSICIAN THOUGHT SHE THAT SHE HAD BECOME DEHYDRATED AND HER BLOOD PRESSURE DROPPED, RESULTING IN SYNCOPE. IT WAS UNK IF THE Patient SUSTAIEND A HEAD INJURY DURING THE FALL, SO SHE WAS TAKEN TO THE HOSP VIA AMBULANCE WHERE SHE WAS ADMITTED FOR A FEW DAYS. NO HEAD INJURIES WERE NOTED UPON EXAM. WHILE IN THE HOSP SHE WAS TREATED WITH BENADRYL AND CLARITIN AND HER BLOOD PRESSURE MED WAS CHANGED TO DIOVAN 160 MG (WITH HYDROCHLOROTHIAZIDE). THE Patient UNDERWENT MANY TESTS (UNSPECIFIED) AND SHE WAS DISCHARGED ON 26 MAY 2006. DISCHARGE INSTRUCTIONS INCLUDED TREATMENT WITH CIMETIDINE (GENERIC), MEDROL, CLARITIN AND BENADRYL. SHE STATTED THAT HER Doctor RULED OUT ASPIRIN ALLERGY AND ALLERGY TO BLOOD PRESSURE MED. SHE WAS GIVEN MULTIPLE ALLERGY TESTS AND IT WAS DETERMINED THAT SHE WAS NOT "PARTICULARLY ALLERGIC" TO ANY FOODS. SHE REPORTED THAT HER Doctor FELT SHE WAS ALLERGIC TO A COMPONENT OF POLIDENT AND HE TOLD HER THERE WAS NO WAY TO TEST FOR THAT. ADDITIONALLY, THE Patient STATED THAT SHE LOST HER JOB DURING THIS TIME, WHICH LED TO HER FEELING DEPRESSED. THE Patient COULD NOT PROVIDE PRODUCT INFO OR LOT CODE BECAUSE SHE NO LONGER HAD THE PRODUCT.

NEITHER THE LOT NUMBER OR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF LYMPH NODE CANCER IN A MALE PATIENT WHO RECEIVED POLIDENT (POLIDENT DENTURE CLEANSER TABLETS) TABLET OVER A PERIOD OF 8 MONTHS FOR DENTAL CLEANING. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TONSILS REMOVED. CONCURRENT MEDICAL CONDITIONS INCLUDED ENLARGED PROSTATE. CONCURRENT MEDICATIONS INCLUDED POLIGRIP (SUPER POLIGRIP), CALCIUM CITRATE (CITRACAL), ASCORBIC ACID (VITAMIN C), FISH OIL, FINASTERIDE (PROSCAR), TOLTERODINE TARTRATE (DETROL), SUPER B, CYANOCOBALMIN ( Vitamin B12), GLUCOSAMINE, DULOXETINE (CYMBALTA) AND SODIUM RABEPRAZOLE (ACIPHEX). ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT AT 2 TABLETS. IN 2006, DURING A CONSULT WITH AN EARS NOSE AND THROAT SPECIALIST, AN ENLARGED LYMPH NODE WAS DISCOVERED ON THE LEFT SIDE OF THE NECK WHICH WAS FOUND TO BE CANCEROUS. THE PURPOSE OF THE INITIAL BY THE CONTACT BY THE PATIENT WAS TO ASK IF POLIDENT CONTAINED ANY BLEACH. HE WAS CONCERNED ABOUT "FREE RADICALS" BECAUSE HE WAS TOLD DENTURES WERE POROUS, AND ASKED IF HIS CANCEROUS LYMPH NODES COULD BE RELATED TO THE USE OF POLIDENT, BECAUSE DOCTORS COULD NOT EXPLAIN THE SOURCE. IN THE FOLLOWING MONTH, THE PATIENT UNDERWENT NECK DISSECTION OF THE LEFT SIDE, INCLUDING REMOVAL OF PART OF THE JUGULAR VEIN DUE TO THE LOCATION OF THE LYMPH NODE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE 3RD DAY. TREATMENT WITH POLIDENT WAS DISCONTINUED. THE PATIENT REPORTED SUBSEQUENT LOSS OF MOVEMENT IN HIS MOUTH AND RESIDUAL SHOULDER NUMBNESS RELATED TO POSSIBLE NERVE TRAUMA OR DAMGE DURING SURGERY. THE PATIENT WAS SCHEDULED TO BEGIN RADIATION THERAPY BEGINNING IN 2 MONTHS LATER FOR A PERIOD OF SIX TO EIGHT WEEKS.

NEITHER THE LOT NUMBER NOR THE PRODUCT ARE AVAILABLE FOR TESTING. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

THE FIRST DAY I USED POLIDENT SMOKERS DENTURE CLEANSER IN 2008, THAT EVENING, A FEW HOURS AFTER THE INITIAL USE AND EXPOSURE, I FIRST EXPERIENCED THE ONSET OF URTICARIA OR HIVES PRIMARILY OVER THE TORSO OF MY BODY BUT ALSO ON MY ARMS. I RECEIVED THE DENTURE NEW 4 DAYS EARLIER AND, WHILE I THOUGHT IT HAD TO BE IN SOME WAY RELATED TO THE DENTURE, IT NEVER OCCURRED TO ME THAT THE CLEANSER MIGHT BE THE IRRITANT. I TOOK BENADRYL TO ONLY PARTIALLY RELIEVE THE SYMPTOMS FOR ABOUT A MONTH, DURING WHICH, I EXPERIENCED SWELLING AND INCREASED SENSITIVITY IN MY LIPS, INFLAMMATION AND PAIN IN MY RIGHT PALLET AND SYMPTOMS OF SINUS INFECTION. I DID MENTION THE HIVES TO MY DENTIST AND THAT THEY SEEMED TO BE IN SOME WAY RELATED BUT HE WAS NOT AWARE OF ANYTHING THAT COULD CAUSE THE REACTION. A MONTH LATER, I HAD TO LEAVE WORK AN HOUR EARLY DUE TO EXCESSIVE ITCHING, THE BENADRYL DIDN'T RELIEVE IT AS WELL AS IT HAD IN THE PAST AND THAT PROMPTED ME TO CONDUCT A YAHOO SEARCH LOOKING FOR ALLERGIC REACTIONS RELATED TO DENTURES. WHILE THERE WERE SOME LINKS TO PAGES DESCRIBING ALLERGIC REACTIONS TO THE DENTURE MATERIAL, THE FIRST LINK I CLICKED ON WAS THE "FDA PUBLIC HEALTH NOTIFICATION: DENTURE CLEANSER ALLERGIC REACTIONS AND MISUSE". THAT IMMEDIATELY MADE FULL SENSE BECAUSE I HADN'T GOTTEN AROUND TO BUYING A DENTURE CLEANSER FOR A FEW DAYS, AND IT WASN'T UNTIL ORIGINAL DATE, IN THE AFTERNOON THAT I SAT DOWN, READ THE INSTRUCTIONS AND THEN USED THE POLIDENT SMOKERS DENTURE CLEANSER FOR THE FIRST TIME. I IMMEDIATELY REMOVED THE DENTURE WHILE FINDING OTHER LINKS THAT FURTHER DESCRIBED THE PROBLEM INCLUDING THE FACT THAT THE POROUS PORTIONS OF THE DENTURE ARE SUBJECT TO STRONG ABSORPTION OF THE ALLERGEN, POTASSIUM MONOPERSULPHATE. MY SYMPTOMS WERE SO SEVERE, EXTENDING TO MORE OF MY EXTREMITIES, THAT I CALLED OFF WORK THE FOLLOWING DAY. IN SPITE OF NOT HAVING USED THE DENTURE SINCE MONDAY EVENING AND HAVING USED BENADRYL, I WOKE UP TWO DAYS LATER, WITH ONE EYE SWOLLEN HALF SHUT AND MY SCALP COVERED WITH ITCHY WELTS IN ADDITION TO THOSE COVERING THE REST OF MY BODY. I CALLED OFF WORK AGAIN AND VISITED MY DENTIST AROUND 9:00 AM A MONTH AFTER THE ORIGINAL DATE IN LATE 2008. HE RECOMMENDED GOING TO AN EMERGENCY DEPT OR URGENT CARE, BUT I CHOSE TO MAKE AN APPOINTMENT WITH AN ALLERGIST. HOWEVER, THE SYMPTOMS CLEARED COMPLETELY, A LITTLE OVER 48 HOURS AFTER THE LAST EXPOSURE. THE FOLLOWING DAY, AFTER HAVING USED MANY METHODS TO CLEAN THE DENTURE INCLUDING ULTRA-SONIC CLEANING PERFORMED BY MY DENTIST, I USED THE DENTURE FOR A HALF HOUR TO EAT A MEAL AND REMOVED IT. IT TOOK ABOUT THREE HOURS FOR THE HIVES TO RETURN THE ABOUT FORTY-EIGHT HOURS FOR THEM TO SUBSIDE AGAIN. I HAVE CONTACTED GLAXO SMITTH KLINE AND THEY ARE SENDING ME A REFUND FOR THE ORIGINAL PURCHASE OF POLIDENT ALONG WITH THE PAPERWORK THEY REQUIRE TO SEEK COMPENSATION FOR THE NEW DENTURE THAT MUST BE MADE. DOSE: NA. FREQUENCY: EVERY OTHER DAY. ROUTE: DENTAL. DATES OF USE: 2008. DIAGNOSIS: CLEANING DENTURE. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

THIS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBED THE OCCURRENCE OF MYELONEUROPATHY IN A Patient WHO REC'D DOUBLE SALT DENTURE CLEANSER (POLIDENT) FOR AN UNK DRUG INDICATION. THE Patient HAD BEEN USING POLIDENT FOR SEVERAL YRS. ON AN UNK DATE, THE Patient STARTED DOUBLE SALT DENTURE CLEANSER (UNK). AT AN UNK TIME AFTER STARTING DOUBLE SALT DENTURE CLEANSER, THE Patient EXPERIENCED MYELONEUROPATHY, HYPOCUPREMIA AND Zinc INCREASED. THE PHYSICIAN CONSIDERED THE EVENTS TO BE CLINICALLY SIGNIFICANT (OR REQUIRING INTERVENTION). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. THE REPORTING PHYSICIAN CONSIDERED THE EVENTS WERE POSSIBLY RELATED TO TREATMENT WITH DOUBLE SALT DENTURE CLEANSER. NEITHER THE PROD NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

.