133 Molesworth Street New Zealand 2 1 MAR 2019 · 133 Molesworth Street PO Box 5013 Wellington 6140...

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2 1 MAR 2019 Ref: H201901187 Dea rallll Response to your request for official information 1 33 Molesworth Street PO Box 5013 Wellington 6140 New Zeala nd T +64 4 496 2000 I refer to your email of 7 March 2019 to the Ministry of Health (the Ministry) requesting under the Official Information Act 1982 (the Act): "Can I have details of all of the CAM adverse reacti on reports for 2018?" Information in response to your request is attached in Appendix One. Please note that some information has been withheld pursuant to: Section 9(2)(a) of the Act, to protect the privacy of natural persons; Section 9(2)(ba)(i) of the Act, to protect information whi ch is subject to an obligation of confidence and making available the information would be likely to prejudice the supply of similar information. I trust this information fulfils your request. You have the right, under section 28 of the Act, to ask the Ombudsman to review any decisions made under this request. Please note that the Ministry may publish this response and any attachments on th e Ministry website, with your personal details removed. hri mes Group Manager Medsafe

Transcript of 133 Molesworth Street New Zealand 2 1 MAR 2019 · 133 Molesworth Street PO Box 5013 Wellington 6140...

Page 1: 133 Molesworth Street New Zealand 2 1 MAR 2019 · 133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand T +64 4 496 2000 I refer to your email of 7 March 2019 to the Ministry

2 1 MAR 2019

Ref: H201901187

Dearallll Response to your request for official information

133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand T +64 4 496 2000

I refer to your email of 7 March 2019 to the Ministry of Health (the Ministry) requesting under the Official Information Act 1982 (the Act):

"Can I have details of all of the CAM adverse reaction reports for 2018?"

Information in response to your request is attached in Appendix One. Please note that some information has been withheld pursuant to:

• Section 9(2)(a) of the Act, to protect the privacy of natural persons; • Section 9(2)(ba)(i) of the Act, to protect information which is subject to an obligation of

confidence and making available the information would be likely to prejudice the supply of similar information.

I trust this information fulfils your request. You have the right, under section 28 of the Act, to ask the Ombudsman to review any decisions made under this request.

Please note that the Ministry may publish this response and any attachments on the Ministry website, with your personal details removed.

hri mes Group Manager Medsafe

Page 2: 133 Molesworth Street New Zealand 2 1 MAR 2019 · 133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand T +64 4 496 2000 I refer to your email of 7 March 2019 to the Ministry

CAM Reports received by the Centre for Adverse Reactions Monitoring [CARM] in 2018

R)fl;, r-Oj

REPORT ORIGIN DATE REACTIONS DRUGS ROUTE DOSE/UNIT BEGAN ENDED AGE SEX OUTCOME

126977 - JAN2018 LEUCOPENIA • MELATONIN • - ~ j 65 F -

127006 - JAN2018 DIARRHOEA • HERBALIFE FORMULA 2 MULTIVITAMIN COMPLEX I - - ~ 72 F -DIZZINESS ' HERBAUFE XTRA-CAL DISORIENTATION • JOINT SUPPORT ADVANCED CONFUSION ' NATURAL RAW GUARANA HYPERCALCAEMIA • PROBIOTIC COMPLEX

• HERBALIFEUNE • HERBALIFE FORMULA 1

127117 - JAN2018 DIARRHOEA 'ARTHREM

~ ~1"'·- 41 F FEVER ANTIHISTAMINES UNCLASSIFIED VOMITING PARACETAMOL HYPO TENSION IBUPROFEN NAUSEA TRAMAOOL

127222 - JAN2018 ANAPHYu\CTIC REACTION • PANADOL RAPID ·~ • - 9 M • MANUKAOIL ;.•_ ll~

127237 - FEB2018 ANAPHYu\CTIC REACTION • OMEPRAZOLE ¢R,-

' - 36 M

• KIWlCRUSH • AMOXICIWN/CLAVULANIC ACID

DEXAMETHASONE CEPHAZOUN

127252 FEB2<l18 APPLICATION SITE OEDEMA ' KIWIHERB !INSECT REPELLANT • - 20m M APPUCA TION SITE RASH

127308 • FEB2018 URTICARIA A . NATURO PHARM ARNICA • - 11 M PRURITUS

127444 - FEB2018 RENAL CALCULUS v- ' BIOCEUTICALS INTESTAMINE I I 34 F HEPATOMEGAL Y • METAGENICS BACTREX ACNE AGGRAVATED ; ' M&R ESSENTIALS - GUT

' EVENING PRIMROSE OIL

NZPhvC - CARM CAM Reports 2018 1

Page 3: 133 Molesworth Street New Zealand 2 1 MAR 2019 · 133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand T +64 4 496 2000 I refer to your email of 7 March 2019 to the Ministry

REPORT QRl~IN DATE REACTIONS DRUG~ ROUTE OO~E/UNIT BEGAN fNQED A~E ~EX ~· QUT!:;QME

127445 - FEB2018 HEPATIC FUNCTION ABNORMAL JAUNDICE

' ARTHREM • - 65 M

PRURITUS FAECES PALE ANOREXIA

127446 - FEB2018 URINE DISCOLOURATION ' ARTHREM I - - 57 F -VISION ABNORMAL MAGNESIUM

127447 - FEB2018 JAUNDICE ' ARTHREM VOMITING PARACETAMOUCODEJNE HEPATIC ENZYMES INCREASED DICLOFENAC ANOREXIA ABDOMINAL PAIN

127451 • FEB2018 HEPATIC ENZYMES INCREASED ' ARTHREM ' GO ARTHRI-REMEDY ~ .,F··~~ - - 57 F -

127458 - FEB2018 URTICARIA 'ARTHREM ·~fli. • - 52 M

127475 - FEB2018 JAUNDICE 'ARTHREM "''"v~ • - 64 F HEPATIC ENZYMES INCREASED PRURITUS PURPURA HAEMATURIA

127492 - FEB2018 JAUNDICE ' ARTHREM e/ • - 69 F PRURITUS HEPATIC ENZYMES INCREASED TIREDNESS

127498 - FEB2018 INFLUENZM.IKE SYMPTOMS C . ARTHREM I - 69 F URTICARIA ~ VITAMIN B COMPLEX VOMITING FISH OIL TASTE METALLIC '0-' MAGNESIUM SYNCOPE ~ CRANBERRY EXTRACT

' ,., I 127544 • MAR2018 INR INCREASED I WARFARIN

I 90 M

DRUG INTERACTION I TURMERIC I -FRUSEMIDE I CODEINE CILAZAPRIL I

NZPhvC - CARM CAM Reports 2018 I 2

Page 4: 133 Molesworth Street New Zealand 2 1 MAR 2019 · 133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand T +64 4 496 2000 I refer to your email of 7 March 2019 to the Ministry

REfQBT QRIGIN DATE REACTIONS DRUGS RO!lIE DOSEruNIT E!E!:.?AN ENDEQ A!:.?E :ml ,' Q!,!T!;;OME

127545 I .. MAR2018 CONJUNCTIVAL CONGESTION • ARTHREM 83 M PRURITUS WARFARJN

METOPROLOL ALLOPURINOL

127583 - MAR2018 HEADACHE • ARTHREM I - \ 51 F PRURITUS MAGNESIUM ABDOMINAL PAIN ASCORBIC ACID CHILLS

127584 • MAR2018 HAJRLOSS • truRX • AO- 37 F -127632 - MAR2018 HEPATIC ENZYMES INCREASED • ARTHREM il~!ili .. 93 F -METOPROLOL

DONEPEZIL PANTOPRAZOLE ~< ATORVASTATIN

-127666 MAR2018 DERMATITIS LICHENOIO 'ARTHREM • f'A' • - 77 M

PHOTOSENSITMTYREACTION

127841 • MAR2018 HEPATIC FUNCTION ABNORMAL 'ARTHREM ~~,- • - - 71 M

128001 - APR2018 HEPATIC ENZYMES INCREASED • ARTHREM u • - - 69 M -~ - .. ~

I - - 81 M -128048 APR2018 HEPATIC CIRRHOSIS • ARTHREM CILAZAPRIL METOPROLOL ALLOPURINOL THYROXINE

~'

128181 - APR2018 ANAPHYLACTIC REACTION ~ ' CALOCURB I •• .. 59 F CETIRIZINE ,:

I 128230 - APR2018 CHOKING ~ ' RHUGER MIXTURE I • - - 16d F

128260 APR2018 CONVULSIONS ~ • GO MULTI TEEM EVERYDAY I .. - 15 F ' GINKGO BILOBA 'l

LAMOTRIGlNE I r, __

~~ I

NZPhvC - CARM CAM Reports 2018 I 3

Page 5: 133 Molesworth Street New Zealand 2 1 MAR 2019 · 133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand T +64 4 496 2000 I refer to your email of 7 March 2019 to the Ministry

REeQRT QRl!;z!N [!ATE REACTIQNS

128323 - MAY2018 PALPITATION

---128362 - MAY2018 CRAMP ABDOMINAL

GASTROESOPHAGEAL REFLUX NAUSEA BOWEL MOTILITY DISORDER HEADACHE

128413 - MAY2018 HEPATIC ENZYMES INCREASED

--128422 - MAY2018 JAUNDICE

HEPATITIS CHOLESTATIC PRURITUS

128532 • MAY2018 JAUNDICE HEPATITIS CHOLESTATIC

128533 - MAY2018 HAEMORRHAGE NOS HEALING IMPAIRED

128599 • MAY2018 EYELID OEDEMA ERYTHEMA HYPERTENSION

128653 - MAY2018 DIARRHOEA

128738 - MAY2018 FACE OEDEMA NECK OEDEMA RASH ERYTHEMATOUS

128800 - JUN2018 DIARRHOEA CRAMP ABDOMINAL

NZPhvC - CARM CAM Reports 2018

DRUGS

'BlACKMORESINSOI.AR

' CALOCURB

'ARTHREM

' ARTHREM

' HARKER HERBALS VERM-EZ MAGNESIUM EVENING PRIMROSE OIL GO VIRAL BOOST+ B12 MIRENA

'TURMERIC ' DIPYRJDAMOI..E

' CALOCURB GLYCERYL TRINITRATE ACElYLSAUCYUC ACID CILAZAPRIL ATORVASTATIN

• CALOCURB QUETIAPINE VENLAFAXINE

' NEEMOIL CETIRIZINE

' CALOCURB MULTIVITAMINS

RQUTE OOSE/UNIT BEGAN ENQEQ AGE SEX QUTCQME

• -• -• 83 F

• 86 F

51 F -I .. -- 75 F

1-- - .. , -I • 27 F

I - - 9M

I - - 42F

4

Page 6: 133 Molesworth Street New Zealand 2 1 MAR 2019 · 133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand T +64 4 496 2000 I refer to your email of 7 March 2019 to the Ministry

REPOBT ORl~N QATE REACTIONS DRUGS ROUTE DO~E/IJNIT BEGAN ENDED AGE SE~ :,: OUTCOME II

128813 - JUN2018 LEUKOCYTOCLASTIC VASCUUTIS • DANDELION

I ' BUPLEURUM ' FRmUAAIA THUNBERGII ' CINNAMON BARK 'ACORUS

128925 - JUN2018 DIARRHOEA ' CALOCURB I 55 M NAUSEA FISH OIL HYPO TENSION ACETYLSAUCYLIC ACID DIZZINESS HEARING DECREASED

128945- JUN2018 AGEUSIA ' BIOCEUTICALS ARMAFORCE (Andrographis) • -·-- 63 F APPETITE DECREASED QUINAPRJL NAUSEA

129205 - JUL2018 CRAMP ABDOMINAL ' CALOCURB ,,. - 37 F DIARRHOEA SALBUTAMOL

12925-3 • JUL2018 URTICARIA ' VITEX AGNUS-CASTUS . ·u ~"" • 42 F DERMATOGRAPHIA

129286 • JUL2018 ANGIOEDEMA ' HEMP OIL CAPSULE . ..,, • - 62 F I - ~ • 129358 JUL2018 CRAMP ABDOMINAL ' CALOCURB F

DIARRHOEA

129399 - JUL2018 HEADACHE ' CALOCURB I - 33 F DIARRHOEA ' FISHOIL

' ' VITAMIND

129400 - JUL2018 DIARRHOEA \.: ~<" 'CALOCURB • 38 F

129532 • AUG2018 VOMmNG ~~

' VIRAL.EX ATTACK (postApr2016) I .. - 59 F CRAMP ABDOMINAL

~ ZOP1CLONE

DIARRHOEA PARACETAMOL - . ~

rl).'-:) J ;

I

NZPhvC - CARM CAM Reports 2018 I 5

Page 7: 133 Molesworth Street New Zealand 2 1 MAR 2019 · 133 Molesworth Street PO Box 5013 Wellington 6140 New Zealand T +64 4 496 2000 I refer to your email of 7 March 2019 to the Ministry

REEQBT QRl!z!N DATE REACTIQNS DR!,!GS RO!fil QQSEl!JNIT BE!iAN ENQED A!.?E SEX

129968 - SEP2018 RENAL FUNCTION ABNORMAL • do TERRA VITALITY SUPPLEMENT I -- 42 F NSAID UNCLASSIFIED MARVELON

130117 - SEP2018 DIARRHOEA ' NATIJRES WAY System Well Ultimate Immunity

I - ,.. 63 F

ABDOMINAL PAIN AMLODIPINE NAUSEA LORATADINE TIREDNESS PARACETAMOL RECTAL BLEEDING ZOPICLONE

130209 - OCT2018 UPS SWEWNG NON-SPECIFIC • CUNIClANs PROSPAN LOZENGES PRURITUS • _r __

71 M -130389 • OCT2018 SKIN ULCERATION ' BLOODROOT PASTE ,. , ,~ 58 M

-130587 • OCT2018 HEPATIC ENZYMES INCREASED 'ARTHREM ,~1· - - 65 F

JAUNDICE HYDROCORTISONE BUTYRATE

130741 - NOV2018 GAMMA-GT INCREASED 'ARTHREM VENLAFAXJNE

• fl}"* __ , I - 68 F

130819 • NOV2018 HEPATIC ENZYMES INCREASED 'ARTHREM

I 62 F -CYPROTERONEACETATE

PROPRANOLOL AMITRJPTYUNE BUDESONIDEIEFORMOTEROL

130839 - N0V2018 NEPHRITIS INTERSTITIAL ' MIRACLE MINERAL SOLUTION I - - 66 F LETROZOLE

130877 NOV2018 HEPATIC FUNCTION ABNORMAL "i ' NATIJRES WAY System Well Ultimate Immunity

I I 82 F ' PARACETAMOL

V' ' RESVERATROL NOS • BENDROFLUAZIDE

PANTOPRAZOLE 1'

NZPhvC - CARM CAM Reports 2018 6