FOI 215-1718 document 5 - TGA

Report

Onset

Case No. Date

Date

261548 04/01/2010s22(1)

261559 05/01/2010 261563 05/01/2010

261583 05/01/2010 261642 06/01/2010

PWTRAN01

State Sex Age Outcome F 61 s22(1) F 40 F 72

F 46 M 32

Case Line Listing

Document 5 Cases Count: 2249

Medicine Centrum Select 50+ (Vitamins and Minerals Combination) -Suspected Mobic (Meloxicam) -Other drug Somac (Pantoprazole) -Other drug

Onset

Time s22(1)

Reaction Paraesthesia Hypertonia Musculoskeletal stiffness Hypersensitivity Feeling hot Musculoskeletal chest pai

Blackmores Bio Magnesium (Vitamin Preparation Compound) -Suspected

Singulair (Montelukast) -Other drug

Asthma

Glucosamine NOS -Suspected Alendro Once-Weekly (Alendronate Sodium) -Other drug Betaloc (Metoprolol Tartrate) -Other drug Caltrate (Calcium Carbonate) -Other drug Endep (Amitriptyline Hydrochloride) -Other drug Fish Oil NOS -Other drug Karvea (Irbesartan) -Other drug Pariet (Rabeprazole Sodium) -Other drug Plavix (Clopidogrel) -Other drug Pravachol (Pravastatin Sodium) -Other drug Serepax (Oxazepam) -Other drug

Hypertension

Metagenics Estrofactors (Herbal Medicines) -Suspected

Metagenics Lipoplex (Herbal Medicines) -Suspected

Ostelin 1000 (Ergocalciferol) -Other drug

Hypersensitivity Rash pustular

Hydroxycut (Herbal Medicines) -Suspected

Headache Tremor Vomiting Palpitations

Report Printed : 22/02/2018 08:42

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Report Case No. Date

Onset Date

261681 07/01/2010

261798 12/01/2010

261799 12/01/2010 261802 12/01/2010 261813 13/01/2010 261883 14/01/2010 261912 15/01/2010

262081 21/01/2010 262083 21/01/2010

State Sex Age Outcome M 50

F 79

F6 F 47 F2 F ?? M 71

F 71 F ??

Case Line Listing

Cases Count: 2249

Medicine Tebonin (Ginkgo Biloba) -Suspected Nasonex Aqueous Nasal Spray (Mometasone Furoate) -Other drug Somac (Pantoprazole) -Other drug Xanax (Alprazolam) -Other drug

Onset Time

Reaction Extrasystoles

Ostevit D (Cholecalciferol) -Suspected Micardis (Telmisartan) -Other drug Rani 2 (Ranitidine) -Other drug

Pain

Neutralice Lotion (Herbal Medicines) -Suspected

Blister Hypersensitivity

Ostevit D (Cholecalciferol) -Suspected

Nausea

Neutralice Lotion (Herbal Medicines) -Suspected

Application site reaction

Microshield Angel Antimicrobial Hand Gel (Ethanol) -Suspected

Anaphylactic reaction

Colocap Balance (Magnesium Sulfate) -Suspected Cartia (Aspirin) -Other drug Lipitor (Atorvastatin) -Other drug Mobilis (Piroxicam) -Other drug

Anaphylactic reaction

OmegaGen Cardio (Herbal Medicines) -Suspected

Micardis (Telmisartan) -Other drug

Haematochezia Flatulence Diarrhoea

OmegaGen Neptune Krill Oil (Euphausia superba oil) -Suspected

Abdominal distension Dyspepsia Diarrhoea

PWTRAN01

Report Printed : 22/02/2018 08:42

Page 2 of 303

Report Case No. Date

Onset Date

262147 22/01/2010

262294 28/01/2010 262304 29/01/2010 262319 29/01/2010 262379 02/02/2010 262402 02/02/2010

262428 03/02/2010 262660 10/02/2010 262773 12/02/2010

263085 23/02/2010

PWTRAN01

Case Line Listing

Cases Count: 2249

State Sex Age Outcome M2 M 69 F 50 F 37 M 23 F ??

M 49 F 34 F 36

F ??

Medicine Incremin Iron Mixture (Vitamins and Minerals Combination) -Suspected

Bulgarian Tribulus Complex (Herbal Medicines) -Suspected Dr Vera's Pure Innovation Activated B Complex (Vitamin Preparation Compound) -Suspected Soya Formula -Suspected Hydroxycut Hardcore (Herbal Medicines) -Suspected Colon Cleanse -Suspected Resveratrol (Herbal Medicines) -Suspected

Friar's Balsam Solution (Herbal Medicines) -Suspected Chinese Medicines -Suspected Lovely Legs (Herbal Medicines) -Suspected Blackmores Horseradish + Garlic (Garlic; Horseradish) -Other drug

Eucalyptus Oil -Suspected Goanna Tea Tree Oil Antiseptic (Melaleuca Oil) -Suspected

Onset Time

Reaction Product colour issue Irritability Mood altered

Hypertension

Paraesthesia Erythema Hyperthyroidism

Hepatotoxicity

Influenza like illness Thirst Anxiety Headache Pharyngeal oedema Panic reaction Gastrointestinal disorder

Rash

Liver function test abnorm

Anxiety Nausea Fear Feeling abnormal Diarrhoea

Application site burn

Report Printed : 22/02/2018 08:42

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Report Case No. Date

Onset Date

263103 24/02/2010

263113 24/02/2010 263319 02/03/2010 263359 02/03/2010

263450 04/03/2010 263480 03/03/2010 263554 08/03/2010 263555 08/03/2010 263687 11/03/2010 263806 15/03/2010

263883 17/03/2010

State Sex Age Outcome F 55

F 56 F ?? F 34

F ?? F 68 M 65 M ?? U ?? F 77

F 17

Case Line Listing

Cases Count: 2249

Medicine

Centrum Tablets (Vitamin Preparation Compound) -Suspected Oestrogens NOS -Other drug

Onset Time

Reaction Dysgeusia

Nature's Sunshine Cascara Sagrada (Herbal Medicines) -Suspected

Anorectal discomfort Dyspepsia

Vitamin E Cream (Alpha-tocopherol) -Suspected

Dermatitis Drug ineffective

Hydroxycut (Herbal Medicines) -Suspected

Monofeme 28 (Ethinylestradiol-Levonorgestrel) -Suspected

Cholestasis Liver function test abnorm

Vitamin E Cream (Alpha-tocopherol) -Suspected

Peripheral swelling Lip swelling

Ezetrol (Ezetimibe) -Suspected Latin Seed (Herbal Medicines) -Suspected

Liver function test increas

ReCharge (Vitamin Preparation Compound) -Suspected

Drug ineffective

Centrum Select 50+ (Vitamins and Minerals Combination) -Suspected

Accidental overdose

ReCharge (Vitamin Preparation Compound) -Suspected

Paraesthesia Pruritus

Nature's Own Complete Sleep (Herbal Medicines) -Suspected

Crestor (Rosuvastatin) -Other drug

Anxiety Nightmare Drug ineffective

Centrum Tablets (Vitamin Preparation Compound) -Suspected

Dermatitis allergic Folliculitis Drug administration error

PWTRAN01

Report Printed : 22/02/2018 08:42

Page 4 of 303

Report Case No. Date

Onset Date

263956 18/03/2010

263968 19/03/2010 264014 19/03/2010 264026 19/03/2010

264178 23/03/2010 264229 24/03/2010 264272 25/03/2010

PWTRAN01

Case Line Listing

Cases Count: 2249

State Sex Age Outcome M ??

Medicine

OsteoEze Active Plus MSM (Glucosamine-Chondroitin-Herbal Medicines) -Suspected

Celebrex (Celecoxib) -Other drug

Onset Time

Reaction Abdominal distension Malaise Epigastric discomfort

U0

Pentavite Infant (Vitamin Preparation Compound) -Suspected

Ferro Liquid (Ferrous Sulphate) -Other drug

Somnolence

M ??

Centrum Select 50+ (Vitamins and Minerals Combination) -Suspected

Insomnia

F 90

Atacand Plus 16/12.5 (Candesartan-hydrochlorothiazide) -Suspected Celery seed (Celery - Apium graveolens) -Suspected Physiotens (Moxonidine) -Suspected Tolvon (Mianserin Hydrochloride) -Suspected Xanax (Alprazolam) -Suspected Pravachol (Pravastatin Sodium) -Other drug

Hyponatraemia Loss of consciousness Confusional state

F ?? F 53

Blackmores Cold Combat Aust L 157861 (Andrographis paniculata) -Suspected

Caltrate 600 (Calcium Carbonate) -Suspected Glucosamine Sulphate -Suspected Nature's Way Fish Oil 1000 (Fish Oil NOS) -Suspected

Chest pain Dyspnoea Hypersensitivity Vomiting

Blister Pruritus

F 80

Nature's Own Complete Sleep (Herbal Medicines -Suspected Pariet (Rabeprazole Sodium) -Other drug Plavix (Clopidogrel) -Other drug Zanidip (Lercanidipine Hydrochloride) -Other drug

Tachycardia Palpitations Hypertension

Report Printed : 22/02/2018 08:42

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