BIOTENE
Report
- Report Number
- 3012293198-2019-00158
- Event Type
- Injury
- Date Received
- October 16, 2019
- Report Date
- September 30, 2019
- Manufacturer
- ULTRADENT PRODUCTS INC/ORATECH LLC
- Product Code
- LFD
- PMA / PMN Number
- K123731
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
ARGUS CASE (B)(4).
ARGUS CASE: (B)(4).
ARGUS CASE (B)(4).
ASPIRATION OF BIOTENE ACCIDENTAL DEVICE INGESTION. SEPSIS (LIKELY SECONDARY TO ASPIRATION PNEUMONIA) SEPSIS. PNEUMONIA CAUSING COUGH. THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA. SORE THROAT. COMPLICATED BY FOUR EPISODES OF NON-BLOODY, NON-BILIOUS EMESIS VOMITING. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA OTHER MANUFACTURER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A 76-YEAR-OLD FEMALE PATIENT WHO RECEIVED BIOTENE ORALBALANCE UNKNOWN FORMULATION (BIOTENE) UNKNOWN (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (BATCH NUMBER 3173509, EXPIRY DATE 28TH FEBRUARY 2021) FOR MYASTHENIC SYNDROME. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MUSCLE WEAKNESS, SMALL CELL LUNG CANCER, URINARY INCONTINENCE, DYSPHAGIA, PULMONARY FIBROSIS, NORMOCYTIC ANEMIA AND HEMANGIOMA OF LIVER. CONCURRENT MEDICAL CONDITIONS INCLUDED MYASTHENIC SYNDROME (PARANEOPLASTIC LAMBERT EATON SYNDROM) AND CHEMOTHERAPY. CONCOMITANT PRODUCTS INCLUDED PANTOPRAZOLE, PILOCARPINE AND FERROUS SULFATE (FERROUS SULPHATE). ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE. ON 8TH FEBRUARY 2019, THE PATIENT STARTED FIRDAPSE 10 MG AT AN UNKNOWN FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT), SEPSIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), PNEUMONIA (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), NEPHROLITHIASIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER, LOW BLOOD PRESSURE AND NIGHT SWEAT. THE ACTION TAKEN WITH BIOTENE WAS UNKNOWN. FIRDAPSE WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, SEPSIS, NEPHROLITHIASIS, COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER AND LOW BLOOD PRESSURE WERE UNKNOWN AND THE OUTCOME OF THE PNEUMONIA WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE NIGHT SWEAT WAS RECOVERING/RESOLVING. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, SEPSIS, PNEUMONIA, NEPHROLITHIASIS, COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER, LOW BLOOD PRESSURE AND NIGHT SWEAT TO BE RELATED TO BIOTENE. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6)2019 . CONSUMER REPORTED, ON(B)(6)2019 A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA A COMPANY REPRESENTATIVE, REGARDING A 76 YEAR OLD FEMALE WHO WAS BEING TREATED WITH FIRDAPSE 10 MG (AMIFAMPRIDINE). ON (B)(6)2019 , ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND THE CASE WAS REASSESSED AS SERIOUS, UNEXPECTED. ON (B)(6)2019 , ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF MEDICAL RECORDS. MEDICAL HISTORY INCLUDED LEMS (LAMBERT-EATON MYASTHENIC SYNDROME). CONCOMITANT PRODUCTS WERE NOT REPORTED. ON(B)(6)2019 , THE PATIENT STARTED TREATMENT WITH FIRDAPSE 10 MG, 8X/DAY ORALLY FOR LEMS. ON AN UNEXPECTED DATE IN (B)(6)2019 1 MONTH AGO RELATIVE TO(B)(6)2019 , AFTER STARTING THE PRODUCT, THE PATIENT EXPERIENCED NIGHT SWEATS WHEN SHE TOOK 2 TABLETS AT NIGHT. THE PATIENT "WAS SUPPOSED TO TAKE 8 TABLETS PER DAY" AND THE REPORTER WAS NOT SURE WHY THE PATIENT WAS TAKING 2 TABLETS AT NIGHT. THE NIGHT SWEATS DID NOT HAPPEN WHEN THE PATIENT TOOK ONE TABLET AT NIGHT. AS OF (B)(6)2019 , WAS REPORTED AS UNKNOWN AND IMPROVED/RESOLVED (AFTER THE NIGHT DOSE REDUCTION). NO ADDITIONAL INFORMATION WAS PROVIDED. ON(B)(6)2019 , IT WAS LEARNED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED WEAKNESS IN HER HANDS AND LEGS AND PRIOR TO USE OF INVESTIGATIONAL DRUG LIKE FIRDAPSE REPORTED AS DCAP MANUFACTURED BY JACOBUS (PRESUMED TO BE 3,4-DAP DIAMINOPYRIDINE FOR 2 YEARS, AT A DOSE OF 20 MG, FOUR TIMES DAILY. CONCOMITANT MEDICATIONS WERE UPDATED TO INCLUDE: MIDODRINE 10 MG TWICE DAILY, PILOCARPINE 5 MG THREE TIMES DAILY, PANTOPRAZOLE 40 MG ONCE DAILY, FERROUS SULFATE TWICE DAILY, BREO INHALER (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE), TYLENOL (ACETAMINOPHIN) AS NEEDED, AND DULCOLAX (BISACODYL) AS NEEDED. ON 08 FEBRUARY THE PATIENT STARTED TREATMENT WITH FIRDAPSE 10 MG AT 20 MG FOUR TIMES DAILY (ALSO REPORTED THAT SHE COULD TAKE 10 MG EVERY HOUR FOR 8 HOURS, BUT SHE DID NOT LIKE TO DO THAT). ON AN UNSPECIFIED DATE IN(B)(6)2019 , THE PATIENT HAD A HORRIBLE COUGH AND WENT TO THE ER (EMERGENCY ROOM). SHE WAS DIAGNOSED WITH PNEUMONIA. SHE RECEIVED ANTIBIOTICS AND HYDRATION AND IT WENT RIGHT AWAY. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS. ON AN UNSPECIFIED DATE AT THE END OF (B)(6)2019 , THE PREVIOUSLY REPORTED NIGHT SWEATS STARTED. THE NIGHTS SWEATS WERE SPORADIC. THE PATIENT WAS LIVING IN AN ASSISTED LIVING FACILITY AND DIDN'T KNOW IF THAT CORRESPONDED WITH THE NIGHT SWEATS, BUT SHE DID NOT THINK SO. IT WOULD HAPPEN ABOUT THREE TIMES PER WEEK AND SHE WOULD LITERALLY HAVE TO PEEL HER SHIRT OFF BECAUSE IT WAS DAMP AND STICKING TO HER. SHE WOULD NOTICE THE DAMPNESS IN THE MORNING UPON WAKING, BUT THE NIGHT SWEATS DID NTO WAKE HER UP FROM ONE DAY, BEFORE RETURNING TO 20 MG, FOUR TIMES A DAY THE FOLLOWING DAY. THE PATIENT THOUGHT HER NIGHT SWEATS. IN MID (B)(6)2019 , THE NIGHT SWEATS BEGAN TO IMPROVE AND MAY HAVE IMPROVED WITH THE LOWER FIRDAPSE DOSE, BUT THE PATIENT WAS NOT SURE. THE PATIENT FOUND THE NIGHT SWEATS TO BE A MINOR CONCERN, SO SHE HADN'T BROUGHT THEM UP TO HER PROVIDER. AS OF (B)(6)2019 , TREATMENT WITH THE PRODUCT WAS ONGOING. THE PNEUMONIA AND COUGH WERE RESOLVED AND THE NIGHT SWEATS WERE IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ON 09 (B)(6)2019 , IT WAS LEARNED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED SMALL CELL LUNG CANCER STATUS POST RADIATION AND CHEMOTHERAPY, PARENEOPLASTIC LAMBERT-EATON SYNDROME WITH CHRONIC MILD PROXIMAL MUSCLE WEAKNESS, WHEELCHAIR USE BUT COULD ALSO USE A WALKER, CHRONIC SOB (SHORTNESS OF BREATH), AND STABLE CHRONIC FINDINGS ON CT CHEST SCANS SUGGESTIVE OF SCARRING/FIBROSIS FROM RADIATION (SCHEDULED BY UCSF FOR EVERY 6 MONTHS). THE PATIENT ALSO HAD SOME WEIGHT LOSSS OF ABOUT 10 POUNDS SINCE (B)(6)2018 (NOT THOUGHT TO BE SECONDARY TO MALIGNANCY), CHRONIC URINARY INCONTINENCE, LIVER LESIONS (LIKELY HEMANGIOMAS; CHRONIC FROM UCSF RECORDS), AND CHRONIC NORMOCYTIC ANEMIA. THE PATIENT WAS ALSO UNDERWEIGHT WITH PROTEIN ENERGY MALNUTRITION WITH CHRONIC POOR APPETITE AND CHRONIC DYSPHAGIA RELATED TO PREVIOUS RADIATION AND CANCER TREATMENT FOR SMALL CELL LUNG CANCER. BMI (BASAL METABOLIC INDEX) 17.8. CONCOMITANT MEFICATIONS INCLUDED MIRTAZAPINE ORALLY, PANTOPRAZOLE ONCE DAILY, PILOCARPINE 5 MG ORALLY THREE TIMES DAILY, MIDODRINE 10 MG ORALLY THREE TIMES DAILY, AND FERROUS FUMARATE 325 MG ORALLY ONCE DAILY. ON (B)(6)2019 , THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA, COMPLICATED BY FOUR EPISODES OF NON-BLOODY, NON-BILLIOUS EMESIS AND ASPIRATION OF BIOTENE, CAUSING COUGH, MILD SHORTNESS OF BREATH, A SORE THROAT, AND WAS ADMITTED. AN XR CHEST SHOWED IRREGULAR FOCAL CONSOLIDATIVE DENSITY CENTRALLY IN THE LEFT LUNG THAT COULD BE DUE TO INFILTRATES OR PNEUMONIA. A CT SHOWED EVIDENCE OF LEFT LOWER LOBE INFILTRATIVE PROCESS WITH ASSOCIATE SMALL PLEURAL EFFUSION (PLEURAL EFFUSION WAS PRESENT ON HER PREVIOUS IMAGES REVIEWED FROM UCSF). THE CT DID NOT VISUALIZE A DISCREET APPENDIX AND THERE WERE MULTIPLE NON-DISTENDED LOOPS OF SMALL BOWEL NOTED ADJACENT TO THE CECUM WHICH COULD NOT BE DELINEATED FROM THE APPENDIX. THEREFORE, APPENDICITIS COULD NOT BE EXCLUDED. THE CT ALSO SHOWED MULTIPLE HYPOATTENTUATING LESIONS SCATTERED THROUGHOUT THE RIGHT AND LEFT LOBES OF THE LIVER. METASTATIC DISEASE CANNOT BE EXCLUDED. ULTRASOUND IMAGING OF THE LIVER TO CONFIRM SOLID VERSUS CYSTIC STRUCTURES WAS RECOMMENDED. THERE WERE ALSO MULTIPLE CORTICAL CYSTS OF THE KIDNEYS. EVIDENCE OF NEPHROLITHIASIS WITHOUT EVIDENCE OF HYDRONEPHROSIS. NO EVIDENCE OF HYDROURETER OR OBSTRUCTIVE UROPATHY. THE HOSPITAL COURSE INCLUDED TREATMENT FOR SEPSIS, LIKELY SECONDARY TO ASPIRATION PNEUMONIA BASED ON HISTORY AND IMAGES. THE PATIENT HAD A COUGH, FEVER, LOW BLOOD PRESSURE (BUT SHE DID TAKE MIDODRINE) AND HISTORY SUGGESTIVE OF POSSIBLE ASPIRATION. SHE WAS STARTED IV(INTRAVENOUS) UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM), THEN SWITCHED TO AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) AND SHOWED SIGNIFICANT CLINICAL IMPROVEMENT. THIS REPORT IS RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON 30 SEPTEMBER 2019. THE SUSPECT PRODUCT FIRDAPSE AND CONCOMITANT MEDICATION CONCOMITANT PRODUCTS INCLUDED PANTOPRAZOLE, PILOCARPINE AND FERROUS SULFATE (FERROUS SULPHATE) WERE REMOVED. THE EVENT OF NEPHROLITHIASIS, DIFFICULTY BREATHING, FEVER AND LOW BLOOD PRESSURE AND NIGHT SWEAT WERE REMOVED. THE OUTCOME OF SEPSIS, COUGH, NAUSEA, SORE THROAT, VOMITING AND PNEUMONIA WERE RECOVERED. THE OUTCOME OF NAUSEA, SORE THROAT, VOMITING WERE RECOVERING.
ASPIRATION OF BIOTENE [ACCIDENTAL DEVICE INGESTION], SEPSIS (LIKELY SECONDARY TO ASPIRATION PNEUMONIA) [SEPSIS], PNEUMONIA [PNEUMONIA], CAUSING COUGH [COUGH], THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA / CHRONIC NAUSEA/VOMITING [NAUSEA] SORE THROAT [SORE THROAT], COMPLICATED BY FOUR EPISODES OF NON-BLOODY, NON-BILIOUS EMESIS /CHRONIC NAUSEA/VOMITING [VOMITING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA OTHER MANUFACTURER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A 76-YEAR-OLD FEMALE PATIENT WHO RECEIVED BIOTENE ORALBALANCE UNKNOWN FORMULATION (BIOTENE) UNKNOWN (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (BATCH NUMBER 3173509, EXPIRY DATE 28TH FEBRUARY 2021) FOR MYASTHENIC SYNDROME. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MUSCLE WEAKNESS, SMALL CELL LUNG CANCER, URINARY INCONTINENCE, DYSPHAGIA, PULMONARY FIBROSIS, NORMOCYTIC ANEMIA AND HEMANGIOMA OF LIVER. CONCURRENT MEDICAL CONDITIONS INCLUDED MYASTHENIC SYNDROME (PARANEOPLASTIC LAMBERT EATON SYNDROM) AND CHEMOTHERAPY. CONCOMITANT PRODUCTS INCLUDED PANTOPRAZOLE, PILOCARPINE AND FERROUS SULFATE (FERROUS SULPHATE). ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE. ON (B)(6) 2019, THE PATIENT STARTED FIRDAPSE 10 MG AT AN UNKNOWN FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT), SEPSIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), PNEUMONIA (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), NEPHROLITHIASIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER, LOW BLOOD PRESSURE AND NIGHT SWEAT. THE ACTION TAKEN WITH BIOTENE WAS UNKNOWN. FIRDAPSE WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, SEPSIS, NEPHROLITHIASIS, COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER AND LOW BLOOD PRESSURE WERE UNKNOWN AND THE OUTCOME OF THE PNEUMONIA WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE NIGHT SWEAT WAS RECOVERING/RESOLVING. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, SEPSIS, PNEUMONIA, NEPHROLITHIASIS, COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER, LOW BLOOD PRESSURE AND NIGHT SWEAT TO BE RELATED TO BIOTENE. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION WAS RECEIVED ON 30 SEPTEMBER 2019. CONSUMER REPORTED, ON (B)(6) 2019, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA A COMPANY REPRESENTATIVE, REGARDING A 76 YEAR OLD FEMALE WHO WAS BEING TREATED WITH FIRDAPSE 10 MG (AMIFAMPRIDINE). ON 02 AUGUST 2019, ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND THE CASE WAS REASSESSED AS SERIOUS, UNEXPECTED. ON 09 SEPTEMBER 2019, ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF MEDICAL RECORDS. MEDICAL HISTORY INCLUDED LEMS (LAMBERT-EATON MYASTHENIC SYNDROME). CONCOMITANT PRODUCTS WERE NOT REPORTED. ON (B)(6) 2019, THE PATIENT STARTED TREATMENT WITH FIRDAPSE 10 MG, 8X/DAY ORALLY FOR LEMS. ON AN UNEXPECTED DATE IN (B)(6) 2019 1 MONTH AGO RELATIVE TO (B)(6) 2019, AFTER STARTING THE PRODUCT, THE PATIENT EXPERIENCED NIGHT SWEATS WHEN SHE TOOK 2 TABLETS AT NIGHT. THE PATIENT "WAS SUPPOSED TO TAKE 8 TABLETS PER DAY" AND THE REPORTER WAS NOT SURE WHY THE PATIENT WAS TAKING 2 TABLETS AT NIGHT. THE NIGHT SWEATS DID NOT HAPPEN WHEN THE PATIENT TOOK ONE TABLET AT NIGHT. AS OF (B)(6) 2019, WAS REPORTED AS UNKNOWN AND IMPROVED/RESOLVED (AFTER THE NIGHT DOSE REDUCTION). NO ADDITIONAL INFORMATION WAS PROVIDED. ON 02 AUGUST 2019, IT WAS LEARNED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED WEAKNESS IN HER HANDS AND LEGS AND PRIOR TO USE OF INVESTIGATIONAL DRUG LIKE FIRDAPSE REPORTED AS DCAP MANUFACTURED BY JACOBUS (PRESUMED TO BE 3,4-DAP DIAMINOPYRIDINE FOR 2 YEARS, AT A DOSE OF 20 MG, FOUR TIMES DAILY. CONCOMITANT MEDICATIONS WERE UPDATED TO INCLUDE: MIDODRINE 10 MG TWICE DAILY, PILOCARPINE 5 MG THREE TIMES DAILY, PANTOPRAZOLE 40 MG ONCE DAILY, FERROUS SULFATE TWICE DAILY, BREO INHALER (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE), TYLENOL (ACETAMINOPHIN) AS NEEDED, AND DULCOLAX (BISACODYL) AS NEEDED. ON 08 FEBRUARY THE PATIENT STARTED TREATMENT WITH FIRDAPSE 10 MG AT 20 MG FOUR TIMES DAILY (ALSO REPORTED THAT SHE COULD TAKE 10 MG EVERY HOUR FOR 8 HOURS, BUT SHE DID NOT LIKE TO DO THAT). ON AN UNSPECIFIED DATE IN (B)(6) 2019, THE PATIENT HAD A HORRIBLE COUGH AND WENT TO THE ER (EMERGENCY ROOM). SHE WAS DIAGNOSED WITH PNEUMONIA. SHE RECEIVED ANTIBIOTICS AND HYDRATION AND IT WENT RIGHT AWAY. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS. ON AN UNSPECIFIED DATE AT THE END OF (B)(6) 2019, THE PREVIOUSLY REPORTED NIGHT SWEATS STARTED. THE NIGHTS SWEATS WERE SPORADIC. THE PATIENT WAS LIVING IN AN ASSISTED LIVING FACILITY AND DIDN'T KNOW IF THAT CORRESPONDED WITH THE NIGHT SWEATS, BUT SHE DID NOT THINK SO. IT WOULD HAPPEN ABOUT THREE TIMES PER WEEK AND SHE WOULD LITERALLY HAVE TO PEEL HER SHIRT OFF BECAUSE IT WAS DAMP AND STICKING TO HER. SHE WOULD NOTICE THE DAMPNESS IN THE MORNING UPON WAKING, BUT THE NIGHT SWEATS DID NTO WAKE HER UP FROM ONE DAY, BEFORE RETURNING TO 20 MG, FOUR TIMES A DAY THE FOLLOWING DAY. THE PATIENT THOUGHT HER NIGHT SWEATS. IN MID (B)(6) 2019, THE NIGHT SWEATS BEGAN TO IMPROVE AND MAY HAVE IMPROVED WITH THE LOWER FIRDAPSE DOSE, BUT THE PATIENT WAS NOT SURE. THE PATIENT FOUND THE NIGHT SWEATS TO BE A MINOR CONCERN, SO SHE HADN'T BROUGHT THEM UP TO HER PROVIDER. AS OF (B)(6) 2019, TREATMENT WITH THE PRODUCT WAS ONGOING. THE PNEUMONIA AND COUGH WERE RESOLVED AND THE NIGHT SWEATS WERE IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ON 09 SEPTEMBER 2019, IT WAS LEARNED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED SMALL CELL LUNG CANCER STATUS POST RADIATION AND CHEMOTHERAPY, PARENEOPLASTIC LAMBERT-EATON SYNDROME WITH CHRONIC MILD PROXIMAL MUSCLE WEAKNESS, WHEELCHAIR USE BUT COULD ALSO USE A WALKER, CHRONIC SOB (SHORTNESS OF BREATH), AND STABLE CHRONIC FINDINGS ON CT CHEST SCANS SUGGESTIVE OF SCARRING/FIBROSIS FROM RADIATION (SCHEDULED BY UCSF FOR EVERY 6 MONTHS). THE PATIENT ALSO HAD SOME WEIGHT LOSSS OF ABOUT 10 POUNDS SINCE (B)(6) 2018 (NOT THOUGHT TO BE SECONDARY TO MALIGNANCY), CHRONIC URINARY INCONTINENCE, LIVER LESIONS (LIKELY HEMANGIOMAS; CHRONIC FROM UCSF RECORDS), AND CHRONIC NORMOCYTIC ANEMIA. THE PATIENT WAS ALSO UNDERWEIGHT WITH PROTEIN ENERGY MALNUTRITION WITH CHRONIC POOR APPETITE AND CHRONIC DYSPHAGIA RELATED TO PREVIOUS RADIATION AND CANCER TREATMENT FOR SMALL CELL LUNG CANCER. BMI (BASAL METABOLIC INDEX) 17.8. CONCOMITANT MEFICATIONS INCLUDED MIRTAZAPINE ORALLY, PANTOPRAZOLE ONCE DAILY, PILOCARPINE 5 MG ORALLY THREE TIMES DAILY, MIDODRINE 10 MG ORALLY THREE TIMES DAILY, AND FERROUS FUMARATE 325 MG ORALLY ONCE DAILY. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA, COMPLICATED BY FOUR EPISODES OF NON-BLOODY, NON-BILLIOUS EMESIS AND ASPIRATION OF BIOTENE, CAUSING COUGH, MILD SHORTNESS OF BREATH, A SORE THROAT, AND WAS ADMITTED. AN XR CHEST SHOWED IRREGULAR FOCAL CONSOLIDATIVE DENSITY CENTRALLY IN THE LEFT LUNG THAT COULD BE DUE TO INFILTRATES OR PNEUMONIA. A CT SHOWED EVIDENCE OF LEFT LOWER LOBE INFILTRATIVE PROCESS WITH ASSOCIATE SMALL PLEURAL EFFUSION (PLEURAL EFFUSION WAS PRESENT ON HER PREVIOUS IMAGES REVIEWED FROM UCSF). THE CT DID NOT VISUALIZE A DISCREET APPENDIX AND THERE WERE MULTIPLE NON-DISTENDED LOOPS OF SMALL BOWEL NOTED ADJACENT TO THE CECUM WHICH COULD NOT BE DELINEATED FROM THE APPENDIX. THEREFORE, APPENDICITIS COULD NOT BE EXCLUDED. THE CT ALSO SHOWED MULTIPLE HYPOATTENTUATING LESIONS SCATTERED THROUGHOUT THE RIGHT AND LEFT LOBES OF THE LIVER. METASTATIC DISEASE CANNOT BE EXCLUDED. ULTRASOUND IMAGING OF THE LIVER TO CONFIRM SOLID VERSUS CYSTIC STRUCTURES WAS RECOMMENDED. THERE WERE ALSO MULTIPLE CORTICAL CYSTS OF THE KIDNEYS. EVIDENCE OF NEPHROLITHIASIS WITHOUT EVIDENCE OF HYDRONEPHROSIS. NO EVIDENCE OF HYDROURETER OR OBSTRUCTIVE UROPATHY. THE HOSPITAL COURSE INCLUDED TREATMENT FOR SEPSIS, LIKELY SECONDARY TO ASPIRATION PNEUMONIA BASED ON HISTORY AND IMAGES. THE PATIENT HAD A COUGH, FEVER, LOW BLOOD PRESSURE (BUT SHE DID TAKE MIDODRINE) AND HISTORY SUGGESTIVE OF POSSIBLE ASPIRATION. SHE WAS STARTED IV(INTRAVENOUS) UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM), THEN SWITCHED TO AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) AND SHOWED SIGNIFICANT CLINICAL IMPROVEMENT. THIS REPORT IS RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON 30 SEPTEMBER 2019. THE SUSPECT PRODUCT FIRDAPSE AND CONCOMITANT MEDICATION CONCOMITANT PRODUCTS INCLUDED PANTOPRAZOLE, PILOCARPINE AND FERROUS SULFATE (FERROUS SULPHATE) WERE REMOVED. THE EVENT OF NEPHROLITHIASIS, DIFFICULTY BREATHING, FEVER AND LOW BLOOD PRESSURE AND NIGHT SWEAT WERE REMOVED. THE OUTCOME OF SEPSIS, COUGH, NAUSEA, SORE THROAT, VOMITING AND PNEUMONIA WERE RECOVERED. THE OUTCOME OF NAUSEA, SORE THROAT, VOMITING WERE RECOVERING. FOLLOW-UP INFORMATION WAS RECEIVED ON 15 SEPTEMBER 2020. CO-SUSPECT PRODUCT INCLUDED "FIRDAPSE" WITH THE ASSOCIATED EVENTS "DEATH, GENERALIZED WEAKNESS, FATIGUE, INTRACRANIAL BLEED, ACUTE CORONARY SYNDROME, RHABDOMYOLYSIS, RENAL FAILURE, EMERGENCY CARE EXAMINATION, LIMITED MOBILITY, FALL, LOWER BACK PAIN, SHOULDER PAIN, DEHYDRATION, FRACTURE, URINARY TRACT INFECTION, SPEECH DIFFICULT, SLURRED SPEECH, SWOLLEN TONGUE, DYSPNEA, DECREASED APPETITE, ORAL INTAKE REDUCED, CHRONIC CONSTIPATION, DIARRHEA, HYPOMAGNESEMIA, ACUTE KIDNEY INJURY, HYPERCALCEMIA, RESPONSES VOLUNTARY REDUCED, HYPOTENSION, ASPIRATION PNEUMONIA , NIGHT SWEATS". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED FRACTURED HIP, ASTHENIA, HYPERTENSION, HYPOPHAGIA, HYPOTENSION, GASTROESOPHAGEAL REFLUX, INSOMNIA, FATIGUE, ORTHOSTATIC HYPOTENSION, SCOLIOSIS, OSTEOPENIA, HYPOVITAMINOSIS AND CONSTIPATION. CONCOMITANT PRODUCTS INCLUDED PANTOPRAZOLE, FERROUS SULFATE, BISACODYL (DULCOLAX), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), PILOCARPINE, FLUTICASONE FUROATE + VILANTEROL TRIFENATATE (BREO), PARACETAMOL (TYLENOL), AMBIGUOUS MEDICATION NOS (MIDODRINE TABLET), MIRTAZAPINE AND MIRTAZAPINE (REMERON). HISTORICAL CONDITIONS, LAB DATE AND RELEVANT TEST FIELDS WERE UPDATED.
ASPIRATION OF BIOTENE [ACCIDENTAL DEVICE INGESTION] SEPSIS (LIKELY SECONDARY TO ASPIRATION PNEUMONIA) [SEPSIS] PNEUMONIA [PNEUMONIA] THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA / CHRONIC NAUSEA/VOMITING [NAUSEA] CAUSING COUGH [COUGH] SORE THROAT [SORE THROAT] COMPLICATED BY FOUR EPISODES OF NON-BLOODY, NON-BILIOUS EMESIS / CHRONIC NAUSEA/VOMITING [VOMITING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA OTHER MANUFACTURER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A 76-YEAR-OLD FEMALE PATIENT WHO RECEIVED BIOTENE ORALBALANCE UNKNOWN FORMULATION (BIOTENE) UNKNOWN (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (BATCH NUMBER 3173509, EXPIRY DATE 28TH FEBRUARY 2021) FOR MYASTHENIC SYNDROME. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MUSCLE WEAKNESS, SMALL CELL LUNG CANCER, URINARY INCONTINENCE, DYSPHAGIA, PULMONARY FIBROSIS, NORMOCYTIC ANEMIA AND HEMANGIOMA OF LIVER. CONCURRENT MEDICAL CONDITIONS INCLUDED MYASTHENIC SYNDROME (PARANEOPLASTIC LAMBERT EATON SYNDROM) AND CHEMOTHERAPY. CONCOMITANT PRODUCTS INCLUDED PANTOPRAZOLE, PILOCARPINE AND FERROUS SULFATE (FERROUS SULPHATE). ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE. ON (B)(6)2019, THE PATIENT STARTED FIRDAPSE 10 MG AT AN UNKNOWN FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT), SEPSIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), PNEUMONIA (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), NEPHROLITHIASIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER, LOW BLOOD PRESSURE AND NIGHT SWEAT. THE ACTION TAKEN WITH BIOTENE WAS UNKNOWN. FIRDAPSE WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, SEPSIS, NEPHROLITHIASIS, COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER AND LOW BLOOD PRESSURE WERE UNKNOWN AND THE OUTCOME OF THE PNEUMONIA WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE NIGHT SWEAT WAS RECOVERING/RESOLVING. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, SEPSIS, PNEUMONIA, NEPHROLITHIASIS, COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER, LOW BLOOD PRESSURE AND NIGHT SWEAT TO BE RELATED TO BIOTENE. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION WAS RECEIVED ON 30 SEPTEMBER 2019. CONSUMER REPORTED, ON 25 JULY 2019, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA A COMPANY REPRESENTATIVE, REGARDING A 76 YEAR OLD FEMALE WHO WAS BEING TREATED WITH FIRDAPSE 10 MG (AMIFAMPRIDINE). ON 02 AUGUST 2019, ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND THE CASE WAS REASSESSED AS SERIOUS, UNEXPECTED. ON 09 SEPTEMBER 2019, ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF MEDICAL RECORDS. MEDICAL HISTORY INCLUDED LEMS (LAMBERT-EATON MYASTHENIC SYNDROME). CONCOMITANT PRODUCTS WERE NOT REPORTED. ON (B)(6)2019, THE PATIENT STARTED TREATMENT WITH FIRDAPSE 10 MG, 8X/DAY ORALLY FOR LEMS. ON AN UNEXPECTED DATE IN (B)(6)2019 1 MONTH AGO RELATIVE TO (B)(6)2019, AFTER STARTING THE PRODUCT, THE PATIENT EXPERIENCED NIGHT SWEATS WHEN SHE TOOK 2 TABLETS AT NIGHT. THE PATIENT "WAS SUPPOSED TO TAKE 8 TABLETS PER DAY" AND THE REPORTER WAS NOT SURE WHY THE PATIENT WAS TAKING 2 TABLETS AT NIGHT. THE NIGHT SWEATS DID NOT HAPPEN WHEN THE PATIENT TOOK ONE TABLET AT NIGHT. AS OF (B)(6)2019, WAS REPORTED AS UNKNOWN AND IMPROVED/RESOLVED (AFTER THE NIGHT DOSE REDUCTION). NO ADDITIONAL INFORMATION WAS PROVIDED. ON 02 AUGUST 2019, IT WAS LEARNED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED WEAKNESS IN HER HANDS AND LEGS AND PRIOR TO USE OF INVESTIGATIONAL DRUG LIKE FIRDAPSE REPORTED AS DCAP MANUFACTURED BY JACOBUS (PRESUMED TO BE 3,4-DAP DIAMINOPYRIDINE FOR 2 YEARS, AT A DOSE OF 20 MG, FOUR TIMES DAILY. CONCOMITANT MEDICATIONS WERE UPDATED TO INCLUDE: MIDODRINE 10 MG TWICE DAILY, PILOCARPINE 5 MG THREE TIMES DAILY, PANTOPRAZOLE 40 MG ONCE DAILY, FERROUS SULFATE TWICE DAILY, BREO INHALER (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE), TYLENOL (ACETAMINOPHIN) AS NEEDED, AND DULCOLAX (BISACODYL) AS NEEDED. ON 08 FEBRUARY THE PATIENT STARTED TREATMENT WITH FIRDAPSE 10 MG AT 20 MG FOUR TIMES DAILY (ALSO REPORTED THAT SHE COULD TAKE 10 MG EVERY HOUR FOR 8 HOURS, BUT SHE DID NOT LIKE TO DO THAT). ON AN UNSPECIFIED DATE IN (B)(6) 2019, THE PATIENT HAD A HORRIBLE COUGH AND WENT TO THE ER (EMERGENCY ROOM). SHE WAS DIAGNOSED WITH PNEUMONIA. SHE RECEIVED ANTIBIOTICS AND HYDRATION AND IT WENT RIGHT AWAY. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS. ON AN UNSPECIFIED DATE AT THE END OF (B)(6) 2019, THE PREVIOUSLY REPORTED NIGHT SWEATS STARTED. THE NIGHTS SWEATS WERE SPORADIC. THE PATIENT WAS LIVING IN AN ASSISTED LIVING FACILITY AND DIDN'T KNOW IF THAT CORRESPONDED WITH THE NIGHT SWEATS, BUT SHE DID NOT THINK SO. IT WOULD HAPPEN ABOUT THREE TIMES PER WEEK AND SHE WOULD LITERALLY HAVE TO PEEL HER SHIRT OFF BECAUSE IT WAS DAMP AND STICKING TO HER. SHE WOULD NOTICE THE DAMPNESS IN THE MORNING UPON WAKING, BUT THE NIGHT SWEATS DID NTO WAKE HER UP FROM ONE DAY, BEFORE RETURNING TO 20 MG, FOUR TIMES A DAY THE FOLLOWING DAY. THE PATIENT THOUGHT HER NIGHT SWEATS. IN MID (B)(6) 2019, THE NIGHT SWEATS BEGAN TO IMPROVE AND MAY HAVE IMPROVED WITH THE LOWER FIRDAPSE DOSE, BUT THE PATIENT WAS NOT SURE. THE PATIENT FOUND THE NIGHT SWEATS TO BE A MINOR CONCERN, SO SHE HADN'T BROUGHT THEM UP TO HER PROVIDER. AS OF (B)(6)2019, TREATMENT WITH THE PRODUCT WAS ONGOING. THE PNEUMONIA AND COUGH WERE RESOLVED AND THE NIGHT SWEATS WERE IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ON 09 SEPTEMBER 2019, IT WAS LEARNED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED SMALL CELL LUNG CANCER STATUS POST RADIATION AND CHEMOTHERAPY, PARENEOPLASTIC LAMBERT-EATON SYNDROME WITH CHRONIC MILD PROXIMAL MUSCLE WEAKNESS, WHEELCHAIR USE BUT COULD ALSO USE A WALKER, CHRONIC SOB (SHORTNESS OF BREATH), AND STABLE CHRONIC FINDINGS ON CT CHEST SCANS SUGGESTIVE OF SCARRING/FIBROSIS FROM RADIATION (SCHEDULED BY UCSF FOR EVERY 6 MONTHS). THE PATIENT ALSO HAD SOME WEIGHT LOSSS OF ABOUT 10 POUNDS SINCE (B)(6) 2018 (NOT THOUGHT TO BE SECONDARY TO MALIGNANCY), CHRONIC URINARY INCONTINENCE, LIVER LESIONS (LIKELY HEMANGIOMAS; CHRONIC FROM UCSF RECORDS), AND CHRONIC NORMOCYTIC ANEMIA. THE PATIENT WAS ALSO UNDERWEIGHT WITH PROTEIN ENERGY MALNUTRITION WITH CHRONIC POOR APPETITE AND CHRONIC DYSPHAGIA RELATED TO PREVIOUS RADIATION AND CANCER TREATMENT FOR SMALL CELL LUNG CANCER. BMI (BASAL METABOLIC INDEX) 17.8. CONCOMITANT MEFICATIONS INCLUDED MIRTAZAPINE ORALLY, PANTOPRAZOLE ONCE DAILY, PILOCARPINE 5 MG ORALLY THREE TIMES DAILY, MIDODRINE 10 MG ORALLY THREE TIMES DAILY, AND FERROUS FUMARATE 325 MG ORALLY ONCE DAILY. ON (B)(6)2019, THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA, COMPLICATED BY FOUR EPISODES OF NON-BLOODY, NON-BILLIOUS EMESIS AND ASPIRATION OF BIOTENE, CAUSING COUGH, MILD SHORTNESS OF BREATH, A SORE THROAT, AND WAS ADMITTED. AN XR CHEST SHOWED IRREGULAR FOCAL CONSOLIDATIVE DENSITY CENTRALLY IN THE LEFT LUNG THAT COULD BE DUE TO INFILTRATES OR PNEUMONIA. A CT SHOWED EVIDENCE OF LEFT LOWER LOBE INFILTRATIVE PROCESS WITH ASSOCIATE SMALL PLEURAL EFFUSION (PLEURAL EFFUSION WAS PRESENT ON HER PREVIOUS IMAGES REVIEWED FROM UCSF). THE CT DID NOT VISUALIZE A DISCREET APPENDIX AND THERE WERE MULTIPLE NON-DISTENDED LOOPS OF SMALL BOWEL NOTED ADJACENT TO THE CECUM WHICH COULD NOT BE DELINEATED FROM THE APPENDIX. THEREFORE, APPENDICITIS COULD NOT BE EXCLUDED. THE CT ALSO SHOWED MULTIPLE HYPOATTENTUATING LESIONS SCATTERED THROUGHOUT THE RIGHT AND LEFT LOBES OF THE LIVER. METASTATIC DISEASE CANNOT BE EXCLUDED. ULTRASOUND IMAGING OF THE LIVER TO CONFIRM SOLID VERSUS CYSTIC STRUCTURES WAS RECOMMENDED. THERE WERE ALSO MULTIPLE CORTICAL CYSTS OF THE KIDNEYS. EVIDENCE OF NEPHROLITHIASIS WITHOUT EVIDENCE OF HYDRONEPHROSIS. NO EVIDENCE OF HYDROURETER OR OBSTRUCTIVE UROPATHY. THE HOSPITAL COURSE INCLUDED TREATMENT FOR SEPSIS, LIKELY SECONDARY TO ASPIRATION PNEUMONIA BASED ON HISTORY AND IMAGES. THE PATIENT HAD A COUGH, FEVER, LOW BLOOD PRESSURE (BUT SHE DID TAKE MIDODRINE) AND HISTORY SUGGESTIVE OF POSSIBLE ASPIRATION. SHE WAS STARTED IV(INTRAVENOUS) UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM), THEN SWITCHED TO AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) AND SHOWED SIGNIFICANT CLINICAL IMPROVEMENT. THIS REPORT IS RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON 30 SEPTEMBER 2019. THE SUSPECT PRODUCT FIRDAPSE AND CONCOMITANT MEDICATION CONCOMITANT PRODUCTS INCLUDED PANTOPRAZOLE, PILOCARPINE AND FERROUS SULFATE (FERROUS SULPHATE) WERE REMOVED. THE EVENT OF NEPHROLITHIASIS, DIFFICULTY BREATHING, FEVER AND LOW BLOOD PRESSURE AND NIGHT SWEAT WERE REMOVED. THE OUTCOME OF SEPSIS, COUGH, NAUSEA, SORE THROAT, VOMITING AND PNEUMONIA WERE RECOVERED. THE OUTCOME OF NAUSEA, SORE THROAT, VOMITING WERE RECOVERING. FOLLOW-UP INFORMATION WAS RECEIVED ON 15 SEPTEMBER 2020. CO-SUSPECT PRODUCT INCLUDED "FIRDAPSE" WITH THE ASSOCIATED EVENTS "DEATH, GENERALIZED WEAKNESS, FATIGUE, INTRACRANIAL BLEED, ACUTE CORONARY SYNDROME, RHABDOMYOLYSIS, RENAL FAILURE, EMERGENCY CARE EXAMINATION, LIMITED MOBILITY, FALL, LOWER BACK PAIN, SHOULDER PAIN, DEHYDRATION, FRACTURE, URINARY TRACT INFECTION, SPEECH DIFFICULT, SLURRED SPEECH, SWOLLEN TONGUE, DYSPNEA, DECREASED APPETITE, ORAL INTAKE REDUCED, CHRONIC CONSTIPATION, DIARRHEA, HYPOMAGNESEMIA, ACUTE KIDNEY INJURY, HYPERCALCEMIA, RESPONSES VOLUNTARY REDUCED, HYPOTENSION, ASPIRATION PNEUMONIA , NIGHT SWEATS". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED FRACTURED HIP, ASTHENIA, HYPERTENSION, HYPOPHAGIA, HYPOTENSION, GASTROESOPHAGEAL REFLUX, INSOMNIA, FATIGUE, ORTHOSTATIC HYPOTENSION, SCOLIOSIS, OSTEOPENIA, HYPOVITAMINOSIS AND CONSTIPATION. CONCOMITANT PRODUCTS INCLUDED PANTOPRAZOLE, FERROUS SULFATE, BISACODYL (DULCOLAX), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), PILOCARPINE, FLUTICASONE FUROATE + VILANTEROL TRIFENATATE (BREO), PARACETAMOL (TYLENOL), AMBIGUOUS MEDICATION NOS (MIDODRINE TABLET), MIRTAZAPINE AND MIRTAZAPINE (REMERON). HISTORICAL CONDITIONS, LAB DATE AND RELEVANT TEST FIELDS WERE UPDATED. FOLLOW-UP INFORMATION WAS RECEIVED ON 14 DECEMBER 2020. CO-SUSPECT PRODUCTS INCLUDED VORICONAZOLE FOR DRUG USE FOR UNKNOWN INDICATION, RIVAROXABAN (XARELTO) FOR DRUG USE FOR UNKNOWN INDICATION AND PIPERACILLIN + TAZOBACTAM (ZOSYN) FOR DRUG USE FOR UNKNOWN INDICATION. THE PATIENT'S PAST MEDICAL HISTORY INCLUDEDWEIGHT LOSS (WT LOSS OF ABOUT 10 LBS SINCE (B)(6)2018, NOT THOUGHT TO BE 2NDRY TO MALIGNANCY; REPORTED THAT SHE HAD LOST LESS THAN 30 LBS SINCE SCLC DX), DECREASED APPETITE (FROM PREVIOUS CANCER TREATMENT), WHEELCHAIR USER (BASELINE WHEELCHAIR BUT CAN USE WALKER), WALKING AID USER (BASELINE WHEELCHAIR BUT CAN USE WALKER) AND DEPRESSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FIRDAPSE WITH AN ASSOCIATED REACTION OF NO ADVERSE EVENT (ON JACOBUS PRODUCT FOR ABOUT 2 YEARS) AND SULFONAMIDE ANTIBIOTICS WITH AN ASSOCIATED REACTION OF HYPERSENSITIVITY. ON AN UNKNOWN DATE, THE PATIENT STARTED VORICONAZOLE AT AN UNKNOWN DOSE AND FREQUENCY, XARELTO AT AN UNKNOWN DOSE AND FREQUENCY AND ZOSYN AT AN UNKNOWN DOSE AND FREQUENCY. CO-SUSPECT PRODUCT INCLUDED "FIRDAPSE" WITH THE FIRDAPSE" WITH THE ASSOCIATED EVENTS "APPENDICITIS, ACUTE RESPIRATORY FAILURE, HYPOXEMIA, FAILURE TO THRIVE, UNRESPONSIVE TO STIMULI, BRONCHOPULMONARY ASPERGILLOSIS, GASTROINTESTINAL BLEEDING, DEEP VEIN THROMBOSIS, SEPTIC SHOCK, ACUTE MYOCARDIAL INFARCTION, LEUKOCYTOSIS, EOSINOPHILIA, FEEDING DISORDER, APHASIA, GAIT INABILITY, GENERAL PHYSICAL HEALTH DETERIORATION, HYPONATREMIA, HYPERNATREMIA, THROMBOCYTOSIS, BLACK STOOLS, PYURIA, HYPOPHOSPHATEMIA, RENAL CYST, DYSARTHRIA, ARTHRALGIA, LOW BACK PAIN, EXERTIONAL, THROMBOCYTOSIS, DEHYDRATION AND DRY MOUTH. THE ACTION TAKEN WITH VORICONAZOLE WAS UNKNOWN. THE ACTION TAKEN WITH XARELTO WAS UNKNOWN. THE ACTION TAKEN WITH ZOSYN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE APPENDICITIS, ACUTE RESPIRATORY FAILURE, HYPOXEMIA, FAILURE TO THRIVE, UNRESPONSIVE TO STIMULI, BRONCHOPULMONARY ASPERGILLOSIS, GASTROINTESTINAL BLEEDING, DEEP VEIN THROMBOSIS, SEPTIC SHOCK, ACUTE MYOCARDIAL INFARCTION, LEUKOCYTOSIS, EOSINOPHILIA, FEEDING DISORDER, APHASIA, GAIT INABILITY, GENERAL PHYSICAL HEALTH DETERIORATION, HYPONATREMIA, HYPERNATREMIA, THROMBOCYTOSIS, BLACK STOOLS, PYURIA, HYPOPHOSPHATEMIA, RENAL CYST, DYSARTHRIA, ARTHRALGIA, LOW BACK PAIN, THROMBOCYTOSIS, DEHYDRATION AND DRY MOUTH WERE UNKNOWN. HISTORICAL CONDITIONS, LAB DATE AND RELEVANT TEST FIELDS WERE UPDATED. LAB DATE INCLUDED (B)(6)2020-CHEST X-RAY- AN ENTERIC TUBE IS IN PLACE WITH TIP IN THE ABDOMEN BELOW THE MARGIN OF THIS EXAM. THE SIDEHOLE OF THE TUBE OVERLIES THE REGION OF THE PROXIMAL STOMACH. (B)(6)2020-CHEST X-RAY- TRACHEOSTOMY IN EXPECTED POSITION. (B)(6)2020-CHEST X-RAY- NO SIGNIFICANT CHANGE BILATERAL MIXED INTERSTITIAL AND ALVEOLAR OPACITIES LIKELY AREAS OF PNEUMONITIS AS WELL AS PLEURAL EFFUSIONS. (B)(6)2020-CHEST X-RAY-BILATERAL MIXED INTERSTITIAL AND ALVEOLAR DENSITIES PERSIST. (B)(6)2020-CHEST X-RAY-THE TRACHEOSTOMY TUBE IS IN SIMILAR POSITION. IMPROVED AERATION OF THE RIGHT LOWER LUNG ZONE WITH PROMINENCE OF THE RIGHT. NO PNEUMOTHORAX. (B)(6)2020-CHEST X-RAY- REDEMONSTRATION OF MODERATE TO SEVERE DIFFUSE PATCHY AIRSPACE DISEASE WITH MORE FOCAL CONSOLIDATION AT THE LEFT BASE, COMPLETELY OBSCURING THE HEMIDIAPHRAGM.. (B)(6) 2020-CHEST X-RAY-DIFFUSE PATCHY AIRSPACE DISEASE WITH INTERSTITIAL AND ALVEOLAR COMPONENT, WORST AT THE LEFT LUNG BASE, BUT OVERALL SLIGHTLY IMPROVED COMPARED TO THE PRIOR STUDY. PERSISTENT SMALL LEFT PLEURAL EFFUSION. IRREGULAR MASS DENSITY AGAIN PROJECTS ADJACENT TO THE AORTIC KNOB. (B)(6)2020-CHEST X-RAY- UNCHANGED LEFT PLEURAL EFFUSION. (B)(6)2019-COMPUTERISED TOMOGRAM ABDOMEN- LLL INFILTRATIVE PROCESS WITH ASSOCIATED SMALL LEFT PLEURAL EFFUSION (EFFUSION WAS PRESENT ON HER PREVIOUS IMAGES REVIEWED FROM UCSF).
(B)(4).
ASPIRATION OF BIOTENE [ACCIDENTAL DEVICE INGESTION]. SEPSIS (LIKELY SECONDARY TO ASPIRATION PNEUMONIA) [SEPSIS]. PNEUMONIA [PNEUMONIA]. NEPHROLITHIASIS [NEPHROLITHIASIS]. CAUSING COUGH [COUGH]. THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA [NAUSEA]. SORE THROAT [SORE THROAT]. COMPLICATED BY FOUR EPISODES OF NON-BLOODY, NON-BILIOUS EMESIS [VOMITING]. MILD SHORTNESS OF BREATH [DIFFICULTY BREATHING]. FEVER [FEVER]. LOW BLOOD PRESSURE [LOW BLOOD PRESSURE]. SPORADIC NIGHT SWEATS [NIGHT SWEAT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA OTHER MANUFACTURER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED BIOTENE ORALBALANCE UNKNOWN FORMULATION (BIOTENE) UNKNOWN (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (BATCH NUMBER 3173509, EXPIRY DATE 28TH FEBRUARY 2021) FOR MYASTHENIC SYNDROME. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MUSCLE WEAKNESS, SMALL CELL LUNG CANCER, URINARY INCONTINENCE, DYSPHAGIA, PULMONARY FIBROSIS, NORMOCYTIC ANEMIA AND HEMANGIOMA OF LIVER. CONCURRENT MEDICAL CONDITIONS INCLUDED MYASTHENIC SYNDROME (PARANEOPLASTIC LAMBERT EATON SYNDROME) AND CHEMOTHERAPY. CONCOMITANT PRODUCTS INCLUDED PANTOPRAZOLE, PILOCARPINE AND FERROUS SULFATE (FERROUS SULPHATE). ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE. ON (B)(6) 2019, THE PATIENT STARTED FIRDAPSE 10 MG AT AN UNKNOWN FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT), SEPSIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), PNEUMONIA (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), NEPHROLITHIASIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER, LOW BLOOD PRESSURE AND NIGHT SWEAT. THE ACTION TAKEN WITH BIOTENE WAS UNKNOWN. FIRDAPSE WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, SEPSIS, NEPHROLITHIASIS, COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER AND LOW BLOOD PRESSURE WERE UNKNOWN AND THE OUTCOME OF THE PNEUMONIA WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE NIGHT SWEAT WAS RECOVERING/RESOLVING. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, SEPSIS, PNEUMONIA, NEPHROLITHIASIS, COUGH, NAUSEA, SORE THROAT, VOMITING, DIFFICULTY BREATHING, FEVER, LOW BLOOD PRESSURE AND NIGHT SWEAT TO BE RELATED TO BIOTENE. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION WAS RECEIVED ON 30 SEPTEMBER 2019. CONSUMER REPORTED, ON (B)(6) 2019, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA A COMPANY REPRESENTATIVE, REGARDING A (B)(6) YEAR OLD FEMALE WHO WAS BEING TREATED WITH FIRDAPSE 10 MG (AMIFAMPRIDINE). ON 02 AUGUST 2019, ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND THE CASE WAS REASSESSED AS SERIOUS, UNEXPECTED. ON 09 SEPTEMBER 2019, ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF MEDICAL RECORDS. MEDICAL HISTORY INCLUDED LEMS (LAMBERT-EATON MYASTHENIC SYNDROME). CONCOMITANT PRODUCTS WERE NOT REPORTED. ON (B)(6) 2019, THE PATIENT STARTED TREATMENT WITH FIRDAPSE 10 MG, 8X/DAY ORALLY FOR LEMS. ON AN UNEXPECTED DATE IN (B)(6) 2019 1 MONTH AGO RELATIVE TO (B)(6) 2019, AFTER STARTING THE PRODUCT, THE PATIENT EXPERIENCED NIGHT SWEATS WHEN SHE TOOK 2 TABLETS AT NIGHT. THE PATIENT "WAS SUPPOSED TO TAKE 8 TABLETS PER DAY" AND THE REPORTER WAS NOT SURE WHY THE PATIENT WAS TAKING 2 TABLETS AT NIGHT. THE NIGHT SWEATS DID NOT HAPPEN WHEN THE PATIENT TOOK ONE TABLET AT NIGHT. AS OF (B)(6) 2019, WAS REPORTED AS UNKNOWN AND IMPROVED/RESOLVED (AFTER THE NIGHT DOSE REDUCTION). NO ADDITIONAL INFORMATION WAS PROVIDED. ON 02 AUGUST 2019, IT WAS LEARNED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED WEAKNESS IN HER HANDS AND LEGS AND PRIOR TO USE OF INVESTIGATIONAL DRUG LIKE FIRDAPSE REPORTED AS DCAP MANUFACTURED BY (B)(4) (PRESUMED TO BE 3,4-DAP DIAMINOPYRIDINE FOR 2 YEARS, AT A DOSE OF 20 MG, FOUR TIMES DAILY. CONCOMITANT MEDICATIONS WERE UPDATED TO INCLUDE: MIDODRINE 10 MG TWICE DAILY, PILOCARPINE 5 MG THREE TIMES DAILY, PANTOPRAZOLE 40 MG ONCE DAILY, FERROUS SULFATE TWICE DAILY, BREO INHALER (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE), TYLENOL (ACETAMINOPHIN) AS NEEDED, AND DULCOLAX (BISACODYL) AS NEEDED. ON (B)(6) THE PATIENT STARTED TREATMENT WITH FIRDAPSE 10 MG AT 20 MG FOUR TIMES DAILY (ALSO REPORTED THAT SHE COULD TAKE 10 MG EVERY HOUR FOR 8 HOURS, BUT SHE DID NOT LIKE TO DO THAT). ON AN UNSPECIFIED DATE IN (B)(6) 2019, THE PATIENT HAD A HORRIBLE COUGH AND WENT TO THE ER (EMERGENCY ROOM). SHE WAS DIAGNOSED WITH PNEUMONIA. SHE RECEIVED ANTIBIOTICS AND HYDRATION AND IT WENT RIGHT AWAY. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS. ON AN UNSPECIFIED DATE AT THE END OF (B)(6) 2019, THE PREVIOUSLY REPORTED NIGHT SWEATS STARTED. THE NIGHTS SWEATS WERE SPORADIC. THE PATIENT WAS LIVING IN AN ASSISTED LIVING FACILITY AND DIDN'T KNOW IF THAT CORRESPONDED WITH THE NIGHT SWEATS, BUT SHE DID NOT THINK SO. IT WOULD HAPPEN ABOUT THREE TIMES PER WEEK AND SHE WOULD LITERALLY HAVE TO PEEL HER SHIRT OFF BECAUSE IT WAS DAMP AND STICKING TO HER. SHE WOULD NOTICE THE DAMPNESS IN THE MORNING UPON WAKING, BUT THE NIGHT SWEATS DID NOT WAKE HER UP FROM ONE DAY, BEFORE RETURNING TO 20 MG, FOUR TIMES A DAY THE FOLLOWING DAY. THE PATIENT THOUGHT HER NIGHT SWEATS. IN MID (B)(6) 2019, THE NIGHT SWEATS BEGAN TO IMPROVE AND MAY HAVE IMPROVED WITH THE LOWER FIRDAPSE DOSE, BUT THE PATIENT WAS NOT SURE. THE PATIENT FOUND THE NIGHT SWEATS TO BE A MINOR CONCERN, SO SHE HADN'T BROUGHT THEM UP TO HER PROVIDER. AS OF (B)(6) 2019, TREATMENT WITH THE PRODUCT WAS ONGOING. THE PNEUMONIA AND COUGH WERE RESOLVED AND THE NIGHT SWEATS WERE IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ON 09 SEPTEMBER 2019, IT WAS LEARNED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED SMALL CELL LUNG CANCER STATUS POST RADIATION AND CHEMOTHERAPY, PARENEOPLASTIC LAMBERT-EATON SYNDROME WITH CHRONIC MILD PROXIMAL MUSCLE WEAKNESS, WHEELCHAIR USE BUT COULD ALSO USE A WALKER, CHRONIC SOB (SHORTNESS OF BREATH), AND STABLE CHRONIC FINDINGS ON CT CHEST SCANS SUGGESTIVE OF SCARRING/FIBROSIS FROM RADIATION (SCHEDULED BY UCSF FOR EVERY 6 MONTHS). THE PATIENT ALSO HAD SOME WEIGHT LOSS OF ABOUT 10 POUNDS SINCE (B)(6) 2018 (NOT THOUGHT TO BE SECONDARY TO MALIGNANCY), CHRONIC URINARY INCONTINENCE, LIVER LESIONS (LIKELY HEMANGIOMAS; CHRONIC FROM UCSF RECORDS), AND CHRONIC NORMOCYTIC ANEMIA. THE PATIENT WAS ALSO UNDERWEIGHT WITH PROTEIN ENERGY MALNUTRITION WITH CHRONIC POOR APPETITE AND CHRONIC DYSPHAGIA RELATED TO PREVIOUS RADIATION AND CANCER TREATMENT FOR SMALL CELL LUNG CANCER. BMI (BASAL METABOLIC INDEX) 17.8. CONCOMITANT MEDICATIONS INCLUDED MIRTAZAPINE ORALLY, PANTOPRAZOLE ONCE DAILY, PILOCARPINE 5 MG ORALLY THREE TIMES DAILY, MIDODRINE 10 MG ORALLY THREE TIMES DAILY, AND FERROUS FUMARATE 325 MG ORALLY ONCE DAILY. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA, COMPLICATED BY FOUR EPISODES OF NON-BLOODY, NON-BILIOUS EMESIS AND ASPIRATION OF BIOTENE, CAUSING COUGH, MILD SHORTNESS OF BREATH, A SORE THROAT, AND WAS ADMITTED. AN XR CHEST SHOWED IRREGULAR FOCAL CONSOLIDATIVE DENSITY CENTRALLY IN THE LEFT LUNG THAT COULD BE DUE TO INFILTRATES OR PNEUMONIA. A CT SHOWED EVIDENCE OF LEFT LOWER LOBE INFILTRATIVE PROCESS WITH ASSOCIATE SMALL PLEURAL EFFUSION (PLEURAL EFFUSION WAS PRESENT ON HER PREVIOUS IMAGES REVIEWED FROM UCSF). THE CT DID NOT VISUALIZE A DISCREET APPENDIX AND THERE WERE MULTIPLE NON-DISTENDED LOOPS OF SMALL BOWEL NOTED ADJACENT TO THE CECUM WHICH COULD NOT BE DELINEATED FROM THE APPENDIX. THEREFORE, APPENDICITIS COULD NOT BE EXCLUDED. THE CT ALSO SHOWED MULTIPLE HYPOATTENUATING LESIONS SCATTERED THROUGHOUT THE RIGHT AND LEFT LOBES OF THE LIVER. METASTATIC DISEASE CANNOT BE EXCLUDED. ULTRASOUND IMAGING OF THE LIVER TO CONFIRM SOLID VERSUS CYSTIC STRUCTURES WAS RECOMMENDED. THERE WERE ALSO MULTIPLE CORTICAL CYSTS OF THE KIDNEYS. EVIDENCE OF NEPHROLITHIASIS WITHOUT EVIDENCE OF HYDRONEPHROSIS. NO EVIDENCE OF HYDROURETER OR OBSTRUCTIVE UROPATHY. THE HOSPITAL COURSE INCLUDED TREATMENT FOR SEPSIS, LIKELY SECONDARY TO ASPIRATION PNEUMONIA BASED ON HISTORY AND IMAGES. THE PATIENT HAD A COUGH, FEVER, LOW BLOOD PRESSURE (BUT SHE DID TAKE MIDODRINE) AND HISTORY SUGGESTIVE OF POSSIBLE ASPIRATION. SHE WAS STARTED IV(INTRAVENOUS) UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM), THEN SWITCHED TO AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM) AND SHOWED SIGNIFICANT CLINICAL IMPROVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 991383 | BIOTENE | UNKNOWN | LFD | ULTRADENT PRODUCTS INC/ORATECH LLC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| O | BISACODYL EC (BISACODYL)| BREO ELLIPTA INHALATION POWDER| BREO ELLIPTA INHALATION POWDER| DULCOLAX (BISACODYL) SUPPOSITORY| FERROUS SULFATE (FERROUS SULFATE) UNKNOWN| FERROUS SULFATE (FERROUS SULFATE) UNKNOWN| FERROUS SULFATE (FERROUS SULFATE) UNKNOWN| FERROUS SULPHATE (FERROUS SULFATE)| MIDODRINE (MESALAZINE) (MESALAZINE)| MIDODRINE (MESALAZINE) (MESALAZINE)| MIRTAZAPINE (MIRTAZAPINE) TABLET| PANTOPRAZOLE (PANTOPRAZOLE)| PANTOPRAZOLE (PANTOPRAZOLE) UNKNOWN| PANTOPRAZOLE (PANTOPRAZOLE) UNKNOWN| PILOCARPINE| PILOCARPINE (PILOCARPINE)| REMERON (MIRTAZAPINE)| REMERON (MIRTAZAPINE)| TYLENOL (PARACETAMOL)| TYLENOL (PARACETAMOL) |