annual review of fatalities (january 2017 – …...marc june 2018 – carm quarterly report 37...

MARC June 2018 – CARM Quarterly Report 37

Section 5: Special Reports

Annual Review of Fatalities (January 2017 – December 2017)

Overview

There were 92 reports of death submitted to CARM in the context of medicine use involving 137medication administrations (i.e. more than one medication may be implicated in each report). In 52%of cases (n=48) a causal relationship to the medicine(s) identified was assessed as either unrelated(26%) or the cause of death was unclassifiable (26%). In 48% of reports (n=44), the medicine wasassessed as potentially contributing to the death (n=21) or resulted in an adverse reaction(s) thatlikely caused the death (n=23) (Table 1). Overview of the deaths that are likely due to the medicationis discussed under Table 6 below. These proportions are similar to those reported in recent years.

The most frequent ATC group of medicines represented by the 137 medicines in the 92 reports was“Nervous System” (n=37) followed by “Blood and Blood forming organs” (n=31) The “Antineoplasticsand Immunomodulating Agents” (n=27) and “Anti-infectives” (n=15) accounted for the bulk of theremaining ATC groups. Four ATC groups had no contributing medicines (Tables 2 & 3). In the Bloodand Blood forming organs ATC group 7 of the 31 reports are for NOAC’s with warfarin accounting for6. With the exception of 16 of the 37 reports in the Nervous System ATC that involve clozapine (allfrom the MAH), in the other ATC groups only single, or occasionally up to 4 reports per medicine arenoted.

Table 4 illustrates the age distribution of all fatal reports to CARM irrespective of causality.In 98% of the reports where the age was known, the over 65 year age group accounted for 76% ofreports and 22% were older than 80 years. There were more males (61%) compared to females(39%). There was only 1 report reflected in the patients under the age of 19 years group. This was areport of sudden death/Sudden Unexpected Death in Infancy in the context of routine childhoodimmunization schedule.

Table 5 lists the 92 reports of fatalities to CARM grouped by ATC group. In 52% of these reports thecause of death was assessed as unrelated or unclassifiable and in the remaining 48% the medicinemay have contributed to or was likely to have caused the reaction that led to death. For many of thereports of death the cases relate to reactions that are well recognized and/or involve complex co-morbidity that may have increased the risk of death. Of the 48% (contributed/likely causal), thereactions reported most frequently were bleeding episodes with anticoagulants accounting for 57%(n=13/23) of reports where death was considered due to the drug and 19% (n=4/21) of reports wherethe drug may have been contributory. The remainder were of diverse drug/reaction combinations.

Table 6 is a subset of the data in Table 5

Attachment 1: Some information withheld under 9(2)(a) and 9(2)(ba)(i)

s 9(2)(ba)(i)

RELEASED UNDER THE OFFICIAL IN

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Table 1: Outcome Overview

Outcome Number of Cases Percentage

Died due to the adverse reaction 23 25.0

Died – drug may be contributory 21 22.8

Died – unrelated to the drug 24 26.1

Died – cause unclassifiable 24 26.1

Total Reports 92 100.0

Table 2: ATC classification Overview

ATC High Level Group No. of Medicines Percentage

Alimentary 3 2.2

Blood and Blood forming organs 3 22.6

Cardiovascular 8 5.8

Dermatological 0

Genito Urinary System and Sex Hormones 0

Systemic Hormones (excl Sex Hormones) 6 4.4

Anti-infectives 15 11.0

Antineoplastics and Immunomodulating Agents 27 19.7

Musculoskeletal 6 4.4

Nervous System 37 27.0

Antiparasitic Products, Insecticides and Repellents 0

Respiratory System 0

Sensory Organs 1 0.7

Miscellaneous 3 2.2

Total Suspect Medicines 137 100.0



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Table 4: Age group and Gender Overview

Age Group Female Male Unknown Total

Under 2 1 1

02 – 09

10 – 19

20 – 29

30 – 39 2 2 4

40 – 49 4 4

50 – 59 4 9 13

60 – 69 4 16 20

70 – 79 15 13 28

80 plus 9 11 20

Unknown 1 1 2

Total 36 56 92 39% 61%



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Table 5: Annual Report Fatal Cases January to December 2017 Reports are grouped according to the ATC classification of the suspect agent(s). Cases where there is more than one suspect agent are listed once in each relevant ATC classification and those cases appearing in more than one ATC classification are identified with ***** below the Report Number. This listing covers the 92 reports, identifying 137 suspect medicines, which resulted in a fatal outcome regardless of causality. REPORT DATE REACTIONS DRUGS AGE SEX Alimentary 123994 APR2017 PERITONITIS * FLEET ENEMA 74 M SEPSIS 126682 NOV2017 SUDDEN DEATH * QUETIAPINE 55 M ***** CARDIOMYOPATHY * RISPERIDONE * GLICLAZIDE * ATORVASTATIN * METFORMIN Blood and Blood forming organs 123301 JAN2017 CEREBRAL HAEMORRHAGE * ALTEPLASE 66 F 124994 JUN2017 CEREBRAL HAEMORRHAGE * ALTEPLASE 81 M DEATH BENDROFLUAZIDE 124998 JUN2017 CEREBRAL HAEMORRHAGE * CLOPIDOGREL 61 F SUBARACHNOID HAEMORRHAGE * ACETYLSALICYLIC ACID DEATH 126119 SEP2017 DUODENAL ULCER HAEMORRHAGIC * ACETYLSALICYLIC ACID 93 F DEATH 124546 MAY2017 GI HAEMORRHAGE * TENOXICAM 78 F ***** DEATH * HEPARIN-LMW - ENOXAPARIN * DABIGATRAN AMOXICILLIN/CLAVULANIC ACID FUSIDIC ACID + BETAMETHASONE 125116 JUL2017 HAEMATEMESIS * DABIGATRAN 80 F ***** GI HAEMORRHAGE * PAROXETINE SHOCK HAEMORRHAGIC ANTIBIOTICS UNCLASSIFIED DEATH THYROXINE



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Blood and Blood forming organs

REPORT DATE REACTIONS DRUGS AGE SEX

125173 JUL2017 THERAPEUTIC RESPONSE DECREASED * DABIGATRAN 73 F ***** GI HAEMORRHAGE * IDARUCIZUMAB

METASTASES NOS

125368 JUL2017 CEREBRAL HAEMORRHAGE * DABIGATRAN 63 M ***** DEATH * IDARUCIZUMAB

* ALTEPLASE

125781 AUG2017 HAEMORRHAGE SUBDURAL * DABIGATRAN 75 F DEATH * HEPARIN-LMW - ENOXAPARIN

* ACETYLSALICYLIC ACID * CLOPIDOGREL

126311 OCT2017 HEPATIC FAILURE * DABIGATRAN 62 M ***** RENAL FAILURE NOS * AMOXICILLIN

DIARRHOEAHISTIOCYTOSIS HAEMATOPHAGICMULTIPLE ORGAN FAILURE

126348 OCT2017 HAEMORRHAGE INTRACRANIAL * DABIGATRAN 80 F

123776 MAR2017 HAEMORRHAGE SUBDURAL * HEPARIN LMW - ENOXAPARIN 78 M DEATH

126945 DEC2017 MEDICATION ERROR * TENECTEPLASE 71 F CEREBRAL HAEMORRHAGEDEATH

123268 JAN2017 CEREBRAL HAEMORRHAGE * WARFARIN 56 M MOTOR VEHICLE ACCIDENT DEATH

123530 FEB2017 DRUG INTERACTION I WARFARIN 60 M ***** INR INCREASED I PHENYTOIN

HAEMORRHAGE INTRACRANIAL VALPROATE SODIUM

124545 MAY2017 CEREBRAL HAEMORRHAGE * WARFARIN 50 M DEATH



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Blood and Blood forming organs REPORT DATE REACTIONS DRUGS AGE SEX 124996 JUN2017 CEREBRAL HAEMORRHAGE * WARFARIN 71 M DEATH 125373 JUL2017 CEREBRAL HAEMORRHAGE * ACETYLSALICYLIC ACID 71 M DEATH * WARFARIN * CLOPIDOGREL 126642 NOV2017 CEREBRAL HAEMORRHAGE * HEPARIN-LMW - ENOXAPARIN 81 F DEATH * WARFARIN 123587 FEB2017 LEUKAEMIA MYELOID * MOROCTOCOG ALPHA RCH 58 M ***** PROGRESSION OF DISEASE * ANTINEOPLASTIC AGENT(S) NOS 125174 JUL2017 CARDIAC ARREST * DIANEAL NOS 61 M * ICODEXTRIN ACETYLSALICYLIC ACID FOLIC ACID ALLOPURINOL Cardiovascular 125610 AUG2017 INR INCREASED * CILAZAPRIL 45 M DIARRHOEA * FRUSEMIDE HEPATIC ENZYMES INCREASED DIGOXIN ASCITES COLCHICINE ALLOPURINOL 126295 OCT2017 ARRHYTHMIA * DOXAZOSIN 78 M CARDIAC ARREST PAROXETINE QUINAPRIL VALPROATE SODIUM SIMVASTATIN 125671 AUG2017 OEDEMA LEGS * ATORVASTATIN 85 M MUSCLE STIFFNESS COLCHICINE MUSCLE WEAKNESS CILAZAPRIL ARTHRALGIA HEAVINESS IN LIMBS



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Cardiovascular REPORT DATE REACTIONS DRUGS AGE SEX 126682 NOV2017 SUDDEN DEATH * QUETIAPINE 55 M ***** CARDIOMYOPATHY * RISPERIDONE * GLICLAZIDE * ATORVASTATIN * METFORMIN 126939 DEC2017 RHABDOMYOLYSIS * SIMVASTATIN 83 M MULTIPLE ORGAN FAILURE * ATORVASTATIN ATRIAL FIBRILLATION HEPATIC FAILURE DEATH Systemic Hormones (excl Sex Hormones) 126940 DEC2017 MULTIPLE ORGAN FAILURE * CORTICOSTEROIDS UNCLASSIFIED 76 F SEPSIS INFECTION STAPHYLOCOCCAL 126669 NOV2017 FRACTURE PATHOLOGICAL * LENALIDOMIDE 82 M ***** * DEXAMETHASONE DABIGATRAN BISOPROLOL ACICLOVIR 125001 JUN2017 PNEUMOCYSTIS JIROVECI INFECTION METHOTREXATE 61 M ***** DEATH * LEFLUNOMIDE * ETANERCEPT * PREDNISONE 125889 SEP2017 OSTEONECROSIS OF JAW * PAMIDRONATE DISODIUM 67 F ***** * PREDNISONE THALIDOMIDE BORTEZOMIB BUDESONIDE/EFORMOTEROL 125492 AUG2017 MYOCARDIAL INFARCTION * CINACALCET 57 F OXYCODONE



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Systemic Hormones (excl Sex Hormones)


126735 DEC2017 LOWER RESP TRACT INFECTION * CINACALCET 68 F RENAL FAILURE ACUTE ALFACALCIDOL

CALCIUM CHLORIDE CALCIUM CARBONATE

Antiinfectives

126311 OCT2017 HEPATIC FAILURE * DABIGATRAN 62 M ***** RENAL FAILURE NOS * AMOXICILLIN

DIARRHOEAHISTIOCYTOSIS HAEMATOPHAGICMULTIPLE ORGAN FAILURE

124541 MAY2017 DIARRHOEA, CLOSTRIDIUM DIFFICILE * AMOXICILLIN/CLAVULANIC ACID 69 M ***** INTESTINAL OBSTRUCTION * TRAMADOL

INTESTINAL PERFORATION * MORPHINE SULPHATE SEPTICAEMIAPERITONITIS

125358 JUL2017 HEPATIC FAILURE * AMOXICILLIN/CLAVULANIC ACID 84 M RASH MADOPAR

QUETIAPINE

125209 JUL2017 RENAL FAILURE ACUTE * COLISTIN 73 F HYPOXIA TRIMETHOPRIMRESPIRATORY ARREST TICAGRELORHYPONATRAEMIA BUDESONIDE/EFORMOTEROL

GLICLAZIDE

124588 MAY2017 HEPATIC ENZYMES INCREASED * CHLOROFORM+ASPIRIN [Extemp] 72 F ***** JAUNDICE * FLUCLOXACILLIN

125375 JUL2017 ANAPHYLACTIC REACTION * PHENOXYMETHYL PENICILLIN 34 F DEATH

125303 JUL2017 RASH PURPURIC * ROXITHROMYCIN 81 F



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Antiinfectives


126667 NOV2017 CARDIAC ARREST * INTRAGAM P 65 M OXYCODONE MOVICOL LAXSOL AMIODARONE

124645 MAY2017 LOWER RESP TRACT INFECTION * RIBAVIRIN M SUDDEN DEATH * SOFOSBUVIR + LEDIPASVIR RENAL FAILURE NOS DYSPNOEA

123586 FEB2017 HEPATIC FAILURE * VIEKIRA PAK 48 M RENAL FAILURE ACUTE RIBAVIRIN THROMBOSIS HEPATIC VEIN METHADONE MEDICATION ERROR OMEPRAZOLE

ALBUMIN

123661 MAR2017 MOTOR NEURONE DISEASE * INFLUENZA - TRIVALENT 77 M

125764 AUG2017 SUDDEN DEATH * ROTA VIRUS VACCINE 5 m F * DTaP-Hexa* PNEUMOCOCCAL VACC - 13

Antineoplastics and Immunomodulating Agents

123587 FEB2017 LEUKAEMIA MYELOID * MOROCTOCOG ALPHA RCH 58 M ***** PROGRESSION OF DISEASE * ANTINEOPLASTIC AGENT(S) NOS

126877 DEC2017 PROGRESSION OF DISEASE * BENDAMUSTINE 66 M * CYTARABINE OCFOSFATE

126402 OCT2017 MYELODYSPLASTIC SYNDROME * BORTEZOMIB 81 M KERATOACANTHOMA * MELPHALAN

PREDNISONE

126393 OCT2017 CARDIAC ARREST * CAPECITABINE 41 M TROPONIN T INCREASED



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Antineoplastics and Immunomodulating Agents REPORT DATE REACTIONS DRUGS AGE SEX 126941 DEC2017 AGRANULOCYTOSIS * EPIRUBICIN 56 M DEATH * OXALIPLATIN INTESTINAL ISCHAEMIA * CAPECITABINE SEPSIS GASTRIC ULCER HAEMORRHAGIC 123209 JAN2017 PROGRESSION OF DISEASE * IBRUTINIB 83 F PNEUMONIA 126743 DEC2017 DIARRHOEA * IBRUTINIB 69 M FLECAINIDE TERAZOSIN ALLOPURINOL 125876 SEP2017 PROGRESSION OF DISEASE * PACLITAXEL 77 F MORPHINE SULPHATE 126262 OCT2017 PROGRESSION OF DISEASE * PACLITAXEL 68 M SEPSIS 123805 MAR2017 PNEUMONITIS * PEMBROLIZUMAB 30 M DEATH 124015 APR2017 ANEURYSM RITUXIMAB 54 F CEREBRAL HAEMORRHAGE METHOTREXATE CONVULSIONS HYDROXYCHLOROQUINE CEREBRAL INFARCTION PREDNISONE ENDOCARDITIS ETIDRONATE DISODIUM 123485 FEB2017 PROGRESSION OF DISEASE * RUXOLITINIB 85 M 126683 NOV2017 SUDDEN DEATH * TRASTUZUMAB 50 F ***** CARDIOMEGALY * CITALOPRAM * FLUOXETINE 124369 MAY2017 CEREBRAL HAEMORRHAGE * ABIRATERONE 79 M



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Antineoplastics and Immunomodulating Agents REPORT DATE REACTIONS DRUGS AGE SEX 124157 APR2017 HYPONATRAEMIA * ALEMTUZUMAB 77 F CONFUSION HYPOREFLEXIA MUSCLE WEAKNESS GUILLAIN-BARRE SYNDROME 125001 JUN2017 PNEUMOCYSTIS JIROVECI INFECTION * METHOTREXATE 61 M ***** DEATH * LEFLUNOMIDE * ETANERCEPT * PREDNISONE 125266 JUL2017 PROGRESSION OF DISEASE * LENALIDOMIDE 48 M 126669 NOV2017 FRACTURE PATHOLOGICAL * LENALIDOMIDE 82 M ***** * DEXAMETHASONE DABIGATRAN BISOPROLOL ACICLOVIR 126670 NOV2017 CEREBRAL ISCHAEMIA * LENALIDOMIDE 77 M PROGRESSION OF DISEASE 124692 JUN2017 PROGRESSION OF DISEASE * POMALIDOMIDE 74 M 125048 JUN2017 CARDIAC ARREST * TOCILIZUMAB 57 M MOUTH DRY METHOTREXATE DYSPHAGIA LEFLUNOMIDE PHARYNGITIS ATORVASTATIN CILAZAPRIL Musculoskeletal 126535 NOV2017 GASTRIC ULCER HAEMORRHAGIC * NAPROXEN 74 F PULMONARY OEDEMA * PARACETAMOL RENAL FAILURE AGGRAVATED



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Musculoskeletal


124546 MAY2017 GI HAEMORRHAGE * TENOXICAM 78 F ***** DEATH * HEPARIN-LMW - ENOXAPARIN

* DABIGATRANAMOXICILLIN/CLAVULANIC ACID FUSIDIC ACID + BETAMETHASONE

125409 JUL2017 MYOCARDIAL INFARCTION * ATRACURIUM 73 F BRONCHOSPASM FENTANYLDEATH MIDAZOLAM

PROPOFOL METARAMINOL

124279 MAY2017 ANAPHYLACTIC SHOCK * SUXAMETHONIUM CHLORIDE 53 M CARDIAC ARREST CEFUROXIMEDEATH

124315 MAY2017 DRESS SYNDROME * ALLOPURINOL 79 F DEATH FLUTICASONE/SALMETEROL

125889 SEP2017 OSTEONECROSIS OF JAW * PAMIDRONATE DISODIUM 67 F ***** * PREDNISONE

THALIDOMIDE BORTEZOMIB BUDESONIDE/EFORMOTEROL

Nervous System

124588 MAY2017 HEPATIC ENZYMES INCREASED * CHLOROFORM+ASPIRIN [Extemp] 72 F ***** JAUNDICE * FLUCLOXACILLIN

126501 NOV2017 BRAIN HYPOXIA * BUPRENORPHINE 87 F SEDATION EXCESSIVE CLONAZEPAMCEREBROVASCULAR DISORDER MORPHINE SULPHATE

LORAZEPAM



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Nervous System REPORT DATE REACTIONS DRUGS AGE SEX 124541 MAY2017 DIARRHOEA, CLOSTRIDIUM DIFFICILE * AMOXICILLIN/CLAVULANIC ACID 69 M ***** INTESTINAL OBSTRUCTION * TRAMADOL INTESTINAL PERFORATION * MORPHINE SULPHATE SEPTICAEMIA PERITONITIS 126885 DEC2017 PULMONARY CARCINOMA * SATIVEX F PROGRESSION OF DISEASE 123530 FEB2017 DRUG INTERACTION I WARFARIN 60 M ***** INR INCREASED I PHENYTOIN HAEMORRHAGE INTRACRANIAL VALPROATE SODIUM 125128 JUL2017 COMPULSIVE REACTION * ROTIGOTINE 90 M ASPIRATION PNEUMONITIS MADOPAR DYSPHAGIA FLUDROCORTISONE LOPERAMIDE AMOXICILLIN/CLAVULANIC ACID 126449 NOV2017 LOWER RESP TRACT INFECTION * ROTIGOTINE 89 M PROGRESSION OF DISEASE 126668 NOV2017 CARCINOMA COLON * ROTIGOTINE 81 M MYOCARDIAL ISCHAEMIA 126849 DEC2017 MYOCARDIAL INFARCTION * ROTIGOTINE 77 F COMPULSIVE REACTION AMANTADINE DONEPEZIL QUETIAPINE FRUSEMIDE 123210 JAN2017 ASPIRATION PNEUMONITIS * CLOZAPINE 79 F 123211 JAN2017 PNEUMONIA * CLOZAPINE 62 M



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Nervous System


123212 JAN2017 STROKE * CLOZAPINE 79 M INSULIN ENALAPRIL METFORMIN METOPROLOL

124684 JUN2017 RESPIRATORY DISORDER * CLOZAPINE 50 F

124685 JUN2017 SUDDEN DEATH * CLOZAPINE 53 M

124686 JUN2017 INTESTINAL ISCHAEMIA * CLOZAPINE 64 M

124687 JUN2017 INTESTINAL OBSTRUCTION * CLOZAPINE 69 M GI HAEMORRHAGE

124688 JUN2017 ARRHYTHMIA * CLOZAPINE 37 F CARDIOMEGALY FLUOXETINE

LORAZEPAM

124689 JUN2017 METASTASES NOS * CLOZAPINE 57 M HEPATIC NEOPLASM MALIGNANT ZUCLOPENTHIXOL PNEUMONIA METFORMINSEPSIS ZOPICLONE

GLIPIZIDE

124690 JUN2017 MYOCARDIAL INFARCTION * CLOZAPINE 63 M

124691 JUN2017 ASPIRATION PNEUMONITIS * CLOZAPINE 75 M BETA BLOCKER NOS

124718 JUN2017 SEPSIS * CLOZAPINE 89 F

125728 AUG2017 PNEUMONIA * CLOZAPINE 84 F THROMBOEMBOLISM



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Nervous System


125729 AUG2017 ASPIRATION PNEUMONITIS * CLOZAPINE 77 F CITALOPRAM

LITHIUM CARBONATE HEPARIN-LMW - ENOXAPARIN

125730 AUG2017 ASPIRATION PNEUMONITIS * CLOZAPINE 39 M

126268 OCT2017 MULTIPLE ORGAN FAILURE * CLOZAPINE 66 M RHABDOMYOLYSIS * OLANZAPINENEUTROPHILIA

123315 JAN2017 MYOCARDIAL INFARCTION * OLANZAPINE 81 M FALL ISOSORBIDEFRACTURE CLOPIDOGRELSEPSIS PANTOPRAZOLE

CILAZAPRIL

124599 MAY2017 ACIDOSIS LACTIC * IOHEXOL 77 M ***** DIARRHOEA * PROCHLORPERAZINE

HYPONATRAEMIAHYPERKALAEMIARENAL IMPAIRMENT

126682 NOV2017 SUDDEN DEATH QUETIAPINE 55 M ***** CARDIOMYOPATHY * RISPERIDONE

* GLICLAZIDE* ATORVASTATIN* METFORMIN

123381 FEB2017 CARDIOMYOPATHY * QUETIAPINE 65 M * AMITRIPTYLINE

126683 NOV2017 SUDDEN DEATH * TRASTUZUMAB 50 F ***** CARDIOMEGALY * CITALOPRAM

* FLUOXETINE



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Nervous System REPORT DATE REACTIONS DRUGS AGE SEX 125116 JUL2017 HAEMATEMESIS * DABIGATRAN 80 F ***** GI HAEMORRHAGE * PAROXETINE SHOCK HAEMORRHAGIC ANTIBIOTICS UNCLASSIFIED DEATH THYROXINE Sensory Organs 123576 FEB2017 MYOCARDIAL INFARCTION * AFLIBERCEPT 77 M Miscellaneous 125173 JUL2017 THERAPEUTIC RESPONSE DECREASED * DABIGATRAN 73 F ***** GI HAEMORRHAGE * IDARUCIZUMAB METASTASES NOS 125368 JUL2017 CEREBRAL HAEMORRHAGE * DABIGATRAN 63 M ***** DEATH * IDARUCIZUMAB * ALTEPLASE 124599 MAY2017 ACIDOSIS LACTIC * IOHEXOL 77 M ***** DIARRHOEA * PROCHLORPERAZINE HYPONATRAEMIA HYPERKALAEMIA RENAL IMPAIRMENT



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Table 6: These cases are extracted separately here for comment but also appear in the overall listing by Medicine Classification ATC code. Case summary and CARM comment are as presented to the va iou MARC meetings. REPORT DATE REACTIONS DRUGS AGE SEX 123268 JAN2017 CEREBRAL HAEMORRHAGE * WARFARIN 56 M MOTOR VEHICLE ACCIDENT

123776 MAR2017 HAEMORRHAGE SUBDURAL * HEPARIN-LMW - ENOXAPARIN 78 M

123805 MAR2017 PNEUMONITIS * PEMBROLIZUMAB 30 M DEATH 124279 MAY2017 ANAPHYLACTIC SHOCK * SUXAMETHONIUM CHLORIDE 53 M CARDIAC ARREST CEFUROXIME DEATH



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Reports where death was due to the adverse reaction … continued REPORT ORIGIN DATE REACTIONS DRUGS AGE SEX 124315 MAY2017 DRESS SYNDROME * ALLOPURINOL 79 F DEATH FLUTICASONE/SALMETEROL

124541 MAY2017 DIARRHOEA, CLOSTRIDIUM DIFFICILE * AMOXICILLIN/CLAVULANIC ACID 69 M INTESTINAL OBSTRUCTION TRAMADOL INTESTINAL PERFORATION MORPHINE SULPHATE PERITONITIS SEPTICEAMIA DEATH

124545 MAY2017 CEREBRAL HAEMORRHAGE * WARFARIN 50 M DEATH



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Reports where death was due to the adverse reaction … continued REPORT DATE REACTIONS DRUGS AGE SEX 124546 MAY2017 GI HAEMORRHAGE * TENOXICAM 78 F DEATH * HEPARIN-LMW - ENOXAPARIN * DABIGATRAN AMOXICILLIN/CLAVULANIC ACID FUSIDIC ACID + BETAMETHASONE

124994 JUN2017 CEREBRAL HAEMORRHAGE * ALTEPLASE 81 M DEATH BENDROFLUAZIDE

124996 JUN2017 CEREBRAL HAEMORRHAGE * WARFARIN 71 M DEATH

124998 JUN2017 CEREBRAL HAEMORRHAGE * CLOPIDOGREL 61 F SUBARACHNOID HAEMORRHAGE * ACETYLSALICYLIC ACID DEATH



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Reports where death was due to the adverse reaction … continued REPORT DATE REACTIONS DRUGS AGE SEX 125001 JUN2017 PNEUMOCYSTIS JIROVECI INFECTION * METHOTREXATE 61 M DEATH * LEFLUNOMIDE * ETANERCEPT * PREDNISONE

125116 JUL2017 HAEMATEMESIS * DABIGATRAN 80 F GI HAEMORRHAGE PAROXETINE SHOCK HAEMORRHAGIC ANTIBIOTICS UNCLASSIFIED DEATH THYROXINE

125368 JUL2017 CEREBRAL HAEMORRHAGE * DABIGATRAN 63 M DEATH * IDARUCIZUMAB * ALTEPLASE



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Reports where death was due to the adverse reaction … continued


125373 JUL2017 CEREBRAL HAEMORRHAGE * ACETYLSALICYLIC ACID 71 M DEATH * WARFARIN

* CLOPIDOGREL

125375 JUL2017 ANAPHYLACTIC REACTION * PHENOXYMETHYL PENICILLIN 34 F DEATH

125409 JUL2017 MYOCARDIAL INFARCTION * ATRACURIUM 73 F BRONCHOSPASM FENTANYLDEATH MIDAZOLAM

PROPOFOL METARAMINOL



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Reports where death was due to the adverse reaction … continued REPORT DATE REACTIONS DRUGS AGE SEX 125781 AUG2017 HAEMORRHAGE SUBDURAL * DABIGATRAN 75 F DEATH * HEPARIN-LMW - ENOXAPARIN * ACETYLSALICYLIC ACID * CLOPIDOGREL

126119 SEP2017 DUODENAL ULCER HAEMORRHAGIC * ACETYLSALICYLIC ACID 93 F DEATH

126642 NOV2017 CEREBRAL HAEMORRHAGE * HEPARIN-LMW - ENOXAPARIN 81 F * WARFARIN



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Reports where death was due to the adverse reaction … continued REPORT DATE REACTIONS DRUGS AGE SEX 126939 DEC2017 RHABDOMYOLYSIS * SIMVASTATIN 83 M MULTIPLE ORGAN FAILURE * ATORVASTATIN ATRIAL FIBRILLATION HEPATIC FAILURE MEDICATION ERROR

126941 DEC2017 AGRANULOCYTOSIS * EPIRUBICIN 56 M GASTRIC ULCER HAEMORRHAGIC * OXALIPLATIN INTESTINAL ISCHAEMIA * CAPECITABINE SEPSIS DIARRHOEA

126945 DEC2017 MEDICATION ERROR * TENECTEPLASE 71 F CEREBRAL HAEMORRHAGE DEATH



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Annual Review of Fatalities (January 2018 – December 2018) Overview

There were 81 reports of death submitted to CARM in the context of medicine use involving 117 medication administrations (i.e. more than one medication may be implicated in each report). In 70% of cases (n=57) a causal relationship to the medicine(s) identified was assessed as either unrelated (44%) or the cause of death was unclassifiable (26%). In 30% of reports (n=24), the medicine was assessed as potentially contributing to the death (n=17) or resulted in an adverse reaction(s) that likely caused the death (n=7) (Table 1). Overview of the deaths that are likely due to the medication is discussed under Table 7 below. Ethnicity as illustrated in Table 2 shows European ethnicity to account for ~69% of deaths in all death relationship to medicine categories with exception of “Due to medication” where European accounts for 86%. However, the cell size for this groups total is small (n=7). Maori ethnicity accounted for 13-15% of all death relationship to drug categories except where the “Drug may be contributory” where it was only 6%. Table 3 illustrates the age distribution of all fatal reports to CARM irrespective of causality. The over 65 year age group accounted for 52% of reports and 12% were older than 80 years. There were more females (52%) compared to males (48%). There were 4 reports reflected in the patients under the age of 2 years. Three of these reported sudden death/Sudden Unexpected Death in Infancy in the context of routine childhood immunization schedule and one report of a death in the context of Somatropin in a child with complex congenital anomalies and resultant complications considered to be contributory to the death outcome. The most frequent ATC group of medicines represented by the 117 medicines in the 81 reports was “Nervous System” (n=34) followed by “Antineoplastics and Immunomodulating Agents” (n=33). The “Blood and Blood forming organs” agents (n=21) and “Anti-infectives” (n=18) accounted for the bulk of the remaining ATC groups. Five ATC groups had no contributing medicines and three only one medicine each, (Tables 4 & 5 ). In the Blood and Blood forming organs ATC group 6 of the 21 reports are for NOAC’s with heparin accounting for 4. With the exception of 22 of the 34 reports in the Nervous System ATC that involve clozapine (all from the MAH), the remainder are for individual medicines. In the other ATC groups only single, or occasionally up to 3 reports per medicine are noted with the exception of 9 reports for pembrolizumab in the Antineoplastic and Immunomodulating Agents group. +Seven of the pembrolizumab reports reported Progression of Disease as a factor in the Death outcome Table 6 lists the 81 reports of fatalities to CARM grouped by ATC group. In 70% of these reports the cause of death was assessed as unrelated or unclassifiable and in the remaining 30% the medicine may have contributed to or was likely to have caused the reaction that led to death. For many of the reports of death the cases relate to reactions that are well recognized and/or involve complex co-morbidity that may have increased the risk of death. Of the 30% (contributed/likely causal), the reactions reported most frequently were bleeding episodes with anticoagulants accounting for 57% (n=4/7) of reports where death was considered due to the drug and 28% (n=5/16) of reports where the drug may have been contributory. The remainder were of diverse drug/reaction combinations. Table 7 is a subset of the data in Table 6

.



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Table 4: ATC classification Overview

ATC High Level Group No. of Medicines Percentage

Alimentary 1 0.8

Blood and Blood forming organs 21 17.9

Cardiovascular 1 0.8

Dermatological 0

Genito Urinary System and Sex Hormones 0

Systemic Hormones (excl Sex Hormones) 3 2.6

Anti-infectives 18 15.4

Antineoplastics and Immunomodulating Agents 33 28.2

Musculoskeletal 5 4.3

Nervous System 34 29 1

Antiparasitic Products, Insecticides and Repellents 0

Respiratory System 0

Sensory Organs 0

Miscellaneous 1 0.8

Total Suspect Medicines 117 100.0



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Table 6: Annual Report Fatal Cases January to December 2018

Reports are grouped according to the ATC classification of the suspect agent(s). Cases where there is more than one suspect agent are listed once in each relevant ATC classification and those cases appearing in more than one ATC classification are identified with ***** below the Report Number. This listing covers the 81 reports, identifying 117 suspect medicines, which resulted in a fatal outcome regardless of causality.


Alimentary

127744 MAR2018 TOXIC EPIDERMAL NECROLYSIS * OMEPRAZOLE 62 M THROAT SORE METOCLOPRAMIDE COUGHING MORPHINE SULPHATE

DOCUSATE + SENNOSIDES

Blood and Blood forming organs

127909 MAR2018 HAEMORRHAGE INTRACRANIAL * ANTICOAGULANTS UNCLASSIFIED 77 M DEATH

129504 AUG2018 ABDOMINAL PAIN * CLOPIDOGREL 80 F HAEMORRHAGE RECTUM FELODIPINE

BACLOFEN ZOPICLONE PARACETAMOL

127728 MAR2018 CEREBRAL HAEMORRHAGE * DABIGATRAN 80 F DEATH * ACETYLSALICYLIC ACID

128551 MAY2018 GI HAEMORRHAGE * DABIGATRAN 77 F MELAENA

128906 JUN2018 GI HAEMORRHAGE * DABIGATRAN 72 M ***** CONGESTIVE HEART FAILURE * DIGOXIN

BRADYCARDIA

128943 JUN2018 STROKE * DABIGATRAN 90 M

129379 JUL2018 MELAENA * DABIGATRAN 81 M ***** RENAL FAI URE ACUTE * IBUPROFEN

RECTAL BLEEDING PARACETAMOL TRAMADOL

MORPHINE SULPHATE



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Blood and Blood forming organs continued REPORT DATE REACTIONS DRUGS AGE SEX 130309 OCT2018 EMBOLISM CEREBRAL * DABIGATRAN 75 M THROMBOSIS 127729 MAR2018 HAEMORRHAGE RETROPERITONEAL * WARFARIN 74 F DEATH * HEPARIN - UNFRACTIONATED * HEPARIN-LMW - ENOXAPARIN 127131 JAN2018 HAEMATEMESIS * IBUPROFEN 70 F ***** MELAENA * HEPARIN-LMW - ENOXAPARIN RENAL IMPAIRMENT * ACETYLSALICYLIC ACID MEDICATION ERROR PRAVASTATIN DEATH INSULIN GLARGINE 127158 JAN2018 DYSPNOEA * TICAGRELOR 66 M MYOCARDIAL INFARCTION 127461 FEB2018 GASTRIC ULCER HAEMORRHAGIC * TICAGRELOR 71 F PROGRESSION OF DISEASE * ACETYLSALICYLIC ACID 130122 SEP2018 HAEMORRHAGE INTRACRANIAL * TICAGRELOR 70 F * HEPARIN - UNFRACTIONATED * ANTICOAGULANTS UNCLASSIFIED 130762 NOV2018 RIGORS * HUMAN SERUM ALBUMIN 49 M DYSPNOEA FENTANYL TACHYPNOEA OXAZEPAM HEPATIC FAILURE CEFTRIAXONE SEPSIS VITAMIN K ANALOGUE Cardiovascular 128906 JUN2018 GI HAEMORRHAGE * DABIGATRAN 72 M ***** CONGESTIVE HEART FAILURE * DIGOXIN BRADYCARDIA



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REPORT DATE REACTIONS DRUGS AGE SEX Systemic Hormones (excl Sex Hormones) 129490 AUG2018 RESPIRATORY FAILURE * SOMATROPIN 914 F APNOEA 130251 OCT2018 AGRANULOCYTOSIS * MIRTAZAPINE 89 M ***** * CORTICOSTEROIDS UNCLASSIFIED THIAMINE MELATONIN MULTIVITE 127294 FEB2018 MOTOR VEHICLE ACCIDENT * BORTEZOMIB 73 M ***** * CYCLOPHOSPHAMIDE * DEXAMETHASONE METOPROLOL ATORVASTATIN Antiinfectives 129620 AUG2018 TOXIC EPIDERMAL NECROLYSIS * CEPHAZOLIN 56 M DEATH * FLUCLOXACILLIN 127918 APR2018 NEPHRITIS INTERSTITIAL * FLUCLOXACILLIN 88 F RENAL IMPAIRMENT OMEPRAZOLE QUINAPRIL FRUSEMIDE DIGOXIN 128501 MAY2018 SUDDEN DEATH * CODEINE 46 M ***** INTENTIONAL OVERDOSE * OLANZAPINE * ROXITHROMYCIN * NORTRIPTYLINE * DIAZEPAM 130578 OCT2018 TOXIC EPIDERMAL NECROLYSIS * FLUCONAZOLE 72 F DEATH CLOTRIMAZOLE 128317 MAY2018 BRONCHIECTASIS * VIEKIRA PAK-RBV 58 F



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Anti-infectives continued REPORT DATE REACTIONS DRUGS AGE SEX 130531 OCT2018 STROKE * IMMUNOGLOBULIN NORMAL 75 M THROMBOCYTOPENIA TRANEXAMIC ACID PULMONARY INFILTRATION CLARITHROMYCIN CEFTRIAXONE INSULIN NEUTRAL 128801 JUN2018 SUDDEN DEATH * ROTA VIRUS VACCINE 903 M * DTaP-Hexa * PNEUMOCOCCAL VACC - 10 129312 JUL2018 SUDDEN INFANT DEATH SYNDROME * ROTA VIRUS VACCINE 903 M * DTaP-Hexa * PNEUMOCOCCAL VACC - 10 130424 OCT2018 SUDDEN INFANT DEATH SYNDROME * ROTA VIRUS VACCINE 902 M * DTaP-Hexa * PNEUMOCOCCAL VACC - 13 128778 MAY2018 CARDIAC ARREST * VARICELLA VACCINE - SHINGLES 79 M * INFLUENZA - QUADRIVALENT CILAZAPRIL AMLODIPINE SIMVASTATIN Antineoplastics and Immunomodulating Agents 130124 SEP2018 PROGRESSION OF DISEASE * AXITINIB 57 M * NIVOLUMAB 127372 FEB2018 ATRIAL FIBRILLATION * BEVACIZUMAB 70 M CARDIAC HYPERTROPHY FRUSEMIDE PNEUMONIA 127801 MAR2018 HYPERTENSION * BEVACIZUMAB 39 F SEPSIS CAPECITABINE



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Antineoplastics and Immunomodulating Agents continued REPORT DATE REACTIONS DRUGS AGE SEX 127294 FEB2018 MOTOR VEHICLE ACCIDENT * BORTEZOMIB 73 M ***** * CYCLOPHOSPHAMIDE * DEXAMETHASONE METOPROLOL ATORVASTATIN 128786 MAY2018 DIARRHOEA * VEMURAFENIB 92 M DEHYDRATION * COBIMETINIB RENAL FAILURE ACUTE 129421 JUL2018 DIARRHOEA * FLUOROURACIL 40 F***** VOMITING * IRINOTECAN HYDROCHLORIDE FIBRILLATION VENTRICULAR * FOLINIC ACID MYOCARDIAL INFARCTION CARDIAC ARREST 127465 FEB2018 PAIN * INFLIXIMAB 28 M BLOATING * MERCAPTOPURINE DEPRESSION SUICIDE 127374 FEB2018 THROMBOSIS VENOUS DEEP * PACLITAXEL 62 M EMBOLISM PULMONARY CARDIAC ARREST PROGRESSION OF DISEASE 129693 AUG2018 PROGRESSION OF DISEASE * PACLITAXEL 64 F 127130 JAN2018 THROMBOCYTOPENIA * PEMBROLIZUMAB 62 M DISSEM. INTRAVASC. COAGULATION 129341 JUL2018 PROGRESSION OF DISEASE * PEMBROLIZUMAB 69 M METASTASES NOS LAXSOL HAEMATEMESIS PARACETAMOL CONSCIOUSNESS DECREASED FENTANYL METHADONE



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Antineoplastics and Immunomodulating Agents continued REPORT DATE REACTIONS DRUGS AGE SEX 129342 JUL2018 PROGRESSION OF DISEASE * PEMBROLIZUMAB 81 M PAIN SIMVASTATIN DEHYDRATION GLICLAZIDE GABAPENTIN INSULIN ISOPHANE 129343 JUL2018 PROGRESSION OF DISEASE * PEMBROLIZUMAB 54 F PARACETAMOL DOMPERIDONE DEXAMETHASONE 130298 OCT2018 MYOSITIS * PEMBROLIZUMAB 68 M 131053 NOV2018 PROGRESSION OF DISEASE * PEMBROLIZUMAB 41 M 131054 NOV2018 PROGRESSION OF DISEASE * PEMBROLIZUMAB 55 F 131055 NOV2018 PROGRESSION OF DISEASE * PEMBROLIZUMAB 60 F 131056 NOV2018 PROGRESSION OF DISEASE * PEMBROLIZUMAB 64 M 128677 MAY2018 MYELOSUPPRESSION * PERTUZUMAB 46 F PROGRESSION OF DISEASE * TRASTUZUMAB * VINORELBINE 130126 SEP2018 PROGRESSION OF DISEASE * SUNITINIB 59 M



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Antineoplastics and Immunomodulating Agents continued REPORT DATE REACTIONS DRUGS AGE SEX 130640 OCT2018 PROGRESSION OF DISEASE * VENETOCLAX 53 F SPLENOMEGALY METOCLOPRAMIDE LYMPHOCYTOSIS OMEPRAZOLE ALLOPURINOL OXYCODONE 127253 FEB2018 LEUKAEMIA MYELOID * ADALIMUMAB 73 M METHOTREXATE 127376 FEB2018 CONVULSIONS * EVEROLIMUS 52 F PROGRESSION OF DISEASE ENCEPHALITIS 127375 FEB2018 PROGRESSION OF DISEASE * LENALIDOMIDE 78 M 127884 MAR2018 BRAIN METASTASES * LENALIDOMIDE 73 M CARCINOMA COLON 129572 AUG2018 PROGRESSION OF DISEASE * POMALIDOMIDE 76 F Musculoskeletal 127131 JAN2018 HAEMATEMESIS * IBUPROFEN 70 F ***** MELAENA * HEPARIN-LMW - ENOXAPARIN RENAL IMPAIRMENT * ACETYLSALICYLIC ACID MEDICATION ERROR PRAVASTATIN DEATH INSULIN GLARGINE 129379 JUL2018 MELAENA * DABIGATRAN 81 M ***** RENAL FAILURE ACUTE * IBUPROFEN RECTAL BLEEDING PARACETAMOL TRAMADOL MORPHINE SULPHATE



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Musculoskeletal continued REPORT DATE REACTIONS DRUGS AGE SEX 128578 MAY2018 HYPOCALCAEMIA * DENOSUMAB 88 F CHOLECALCIFEROL DIGOXIN CALCIUM CARBONATE AMIODARONE 127096 JAN2018 RENAL FAILURE ACUTE * ZOLEDRONATE 75 F PNEUMONIA QUINAPRIL CARDIAC FAILURE METOPROLOL DABIGATRAN MORPHINE SULPHATE 129883 SEP2018 HYPONATRAEMIA * ZOLEDRONATE 85 F POST INJECTION SYNDROME ISOSORBIDE RENAL FAILURE ACUTE METOPROLOL HYPERPHOSPHATAEMIA LOSARTAN HYPOCALCAEMIA DILTIAZEM Nervous System 128501 MAY2018 SUDDEN DEATH * CODEINE 46 M ***** INTENTIONAL OVERDOSE * OLANZAPINE * ROXITHROMYCIN * NORTRIPTYLINE * DIAZEPAM 130125 SEP2018 CHEST PAIN * PREGABALIN 72 F CONFUSION MORPHINE HYDROCHLORIDE SOMNOLENCE THYROXINE DIZZINESS PROGRESSION OF DISEASE 129881 SEP2018 NEUROLEPTIC MALIGNANT SYNDROME * ARIPIPRAZOLE 67 M DEATH 127013 JAN2018 NEUTROPENIA * CLOZAPINE 54 M LEUCOPENIA THROMBOCYTOPENIA



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Nervous Systtem continued REPORT DATE REACTIONS DRUGS AGE SEX 127377 FEB2018 PNEUMONIA * CLOZAPINE 74 F 127378 FEB2018 CARCINOMA COLON * CLOZAPINE 64 F 127595 MAR2018 PULMONARY CARCINOMA * CLOZAPINE 64 F PROGRESSION OF DISEASE 127885 MAR2018 PNEUMONIA * CLOZAPINE 72 F 127886 MAR2018 NEUTROPHILIA * CLOZAPINE 87 M PNEUMONIA CITALOPRAM PROSTATE CANCER LEVODOPA/CARBIDOPA (NOS) PARKINSONISM MADOPAR DEMENTIA DONEPEZIL 127887 MAR2018 GLYCOSYLATED HAEMOGLOBIN INCR * CLOZAPINE 42 F ALKALINE PHOSPHATASE SERUM INCR * CITALOPRAM SYNCOPE * BENZTROPINE MESYLATE MYOCARDIAL ISCHAEMIA LORAZEPAM NALTREXONE 127888 MAR2018 PNEUMONIA * CLOZAPINE 80 F DEMENTIA 127889 MAR2018 DEMENTIA * CLOZAPINE 76 M RESPIRATORY ARREST CARDIAC ARREST 127890 MAR2018 MYOCARDIAL ISCHAEMIA * CLOZAPINE 49 F HYPERLIPAEMIA CILAZAPRIL ATORVASTATIN CARVEDILOL ACETYLSALICYLIC ACID



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Nervous Systtem continued REPORT DATE REACTIONS DRUGS AGE SEX 127959 APR2018 DRUG LEVEL INCREASED * CLOZAPINE 62 F LEUCOPENIA ACETYLSALICYLIC ACID NEUTROPENIA CYCLIZINE METASTASES NOS METFORMIN 128164 APR2018 PULMONARY CARCINOMA * CLOZAPINE 59 F 128509 MAY2018 PROGRESSION OF DISEASE * CLOZAPINE 63 F NEOPLASM MALIGNANT 128561 MAY2018 BRONCHOPNEUMONIA * CLOZAPINE 69 F ENTACAPONE DONEPEZIL CLONAZEPAM LEVODOPA/CARBIDOPA (100/25) 128849 JUN2018 CARDIAC ARREST * CLOZAPINE 64 F NEUTROPHILIA * QUETIAPINE LEUKOCYTOSIS LEVODOPA/CARBIDOPA (100/25) SIMVASTATIN DOMPERIDONE 128850 JUN2018 PNEUMONIA CLOZAPINE 58 F 128851 JUN2018 CARDIOMYOPATHY * CLOZAPINE 74 F EMBOLISM PULMONARY CARDIAC ARREST 128852 JUN2018 PNEUMONIA * CLOZAPINE 88 F SEPSIS VENLAFAXINE 128853 JUN2018 SEPSIS * CLOZAPINE 67 M CHRONIC OBSTRUCT AIRWAYS DISEASE



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Nervous Systtem continued REPORT DATE REACTIONS DRUGS AGE SEX 129584 AUG2018 RENAL FAILURE CHRONIC * CLOZAPINE 54 M 130813 NOV2018 LYMPHOCYTOSIS * CLOZAPINE 47 F NEUTROPHILIA 130816 NOV2018 NEOPLASM MALIGNANT * CLOZAPINE 61 F PROGRESSION OF DISEASE 130251 OCT2018 AGRANULOCYTOSIS * MIRTAZAPINE 89 M ***** * CORTICOSTEROIDS UNCLASSIFIED THIAMINE MELATONIN MULTIVITE 130061 SEP2018 SUICIDE * VENLAFAXINE 25 M * MIRTAZAPINE Miscellaneous 129421 JUL2018 DIARRHOEA * FLUOROURACIL 40 F***** VOMITING * IRINOTECAN HYDROCHLORIDE FIBRILLATION VENTRICULAR * FOLINIC ACID MYOCARDIAL INFARCTION CARDIAC ARREST



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Table 7:

These cases are extracted separately here for comment but also appear in the overall listing by Medicine Classification ATC code. Case summary and CARM comment are as presented to the va iou MARC meetings.


127131 JAN2018 HAEMATEMESIS * IBUPROFEN 70 F MELAENA * HEPARIN-LMW - ENOXAPARIN RENAL IMPAIRMENT * ACETYLSALICYLIC ACID MEDICATION ERROR PRAVASTATIN DEATH INSULIN GLARGINE

127728 MAR2018 CEREBRAL HAEMORRHAGE * DABIGATRAN 80 F DEATH * ACETYLSALICYLIC ACID

127729 MAR2018 HAEMORRHAGE RETROPERITONEAL * WARFARIN 74 F DEATH * HEPARIN - UNFRACTIONATED

* HEPARIN-LMW - ENOXAPARIN



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Reports where death was due to the adverse reaction … continued REPORT ORIGIN DATE REACTIONS DRUGS AGE SEX 127909 MAR2018 HAEMORRHAGE INTRACRANIAL * ANTICOAGULANTS UNCLASSIFIED 77 M DEATH

129620 AUG2018 TOXIC EPIDERMAL NECROLYSIS * CEPHAZOLIN 56 M * FLUCLOXACILLIN

129881 SEP2018 NEUROLEPTIC MALIGNANT SYNDROME * ARIPIPRAZOLE 67 M

130578 OCT2018 TOXIC EPIDERMAL NECROLYSIS * FLUCONAZOLE 72 F CLOTRIMAZOLE



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annual review of fatalities (january 2017 – …...marc june 2018 – carm quarterly report 37...

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