Revised: 23 June 2022

Safety Information

Archive

This section contains links to previous safety communications. Please note that the information contained in these communications may have been superseded. Check the product information for your medicine or medical device for the current known safety information

2020

Publication date Communication Product Type Topic Update date
10 December 2020 Monitoring Medicine M2 Logo UPDATE: Potential interaction between fluoxetine and levothyroxine  
10 December 2020 Monitoring Medicine Antiseptic Soothing Cream: review of the benefits and risks requested under section 36 of the Medicines Act 1981  
6 November 2020 Alert Medicine UPDATE: Important updates to clozapine data sheets and monitoring during covid-19 pandemic  
30 October 2020 Monitoring Medicine UPDATE: Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients  
23 October 2020 Monitoring Medicine Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients 30 October 2020
19 October 2020 Monitoring Medicine Technical issue with CareLink Plus database affecting clozapine monitoring  
29 September 2020 Monitoring Medicine M2 Logo Possible risk of psoriasis exacerbation with bupropion 7 April 2021
15 September 2020 Alert Medicine Medsafe is issuing a warning that Elevacity Elevate Smart Coffee (Version 3) should not be consumed – statement under section 98 of the Medicines Act 1981  
3 September 2020 Alert Device Update - Yes! Cassette Pregnancy Test Kit (also known as Smiths BioMed Rapid Pregnancy Test Kit) – Reports of false positives presenting as faint lines and inconclusive results 2 March 2021
31 July 2020 Monitoring Medicine Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy 16 March 2021
23 July 2020 Alert Device Yes! Cassette Pregnancy Test Kit (also known as Smiths BioMed Rapid Pregnancy Test Kit) – Reports of false positives presenting as faint lines and inconclusive results 3 September 2020
9 June 2020 Alert Medicine Important updates to clozapine data sheets and monitoring during covid-19 pandemic  
31 May 2020 Monitoring Medicine Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy  
28 May 2020 Alert Medicine Miracle Mineral Solution – dangerous and potentially life-threatening side effects 8 April 2022
21 May 2020 Monitoring Medicine M² Logo Update - Possible risk of vasculitis with dabigatran (Pradaxa)  
21 May 2020 Monitoring Medicine M² Logo Potential interaction between fluoxetine and levothyroxine 10 December 2020
13 May 2020 Monitoring Medicine Potential interaction between fluoxetine and levothyroxine 21 May 2020
27 March 2020 Alert Device Mentor Siltex breast implants and anaplastic large cell lymphoma  
27 March 2020 Alert Device Allergan breast implants and anaplastic large cell lymphoma  
23 January 2020 Monitoring Medicine Update - Dolutegravir and the possible risk of neural tube defects when taken early in pregnancy  
23 January 2020 Monitoring Medicine  Update - Everet (levetiracetam) - supply and potential seizure control issues for patients  
8 January 2020 Monitoring Medicine M² Logo Update - Risk of infections with Prolia (denosumab)  
8 January 2020 Monitoring Medicine M² Logo Update - Tramadol and opioid effects in breastfeeding babies  

2019

Publication date Communication Product Type Topic Update date
20 December 2019 Monitoring Medicine Update on suspected adverse reaction reports to lamotrigine after changing brands  
19 December 2019 Alert Medicine EpiPen® Jr 150 mcg Adrenaline (epinephrine) Auto-Injector containing trace levels of Pralidoxime  
9 December 2019 Monitoring Medicine M2 Logo Update - Isotretinoin and Obsessive Compulsive Disorder (OCD)  
20 November 2019 Alert Medicine Consent to distribute Cafergot tablets (ergotamine tartrate 1 mg + caffeine 100 mg) will be prohibited under Section 36 of the Medicines Act 1981 on 1 May 2020  
14 November 2019 Monitoring Medicine M² Logo Possible risk of vasculitis with dabigatran (Pradaxa)  
12 November 2019 Monitoring Medicine Suspected adverse reaction reports to lamotrigine after changing brands  
7 November 2019 Monitoring Device Update - Breast Implants and anaplastic large cell lymphoma  
7 November 2019 Monitoring Medicine Everet (levetiracetam) - supply and potential seizure control issues for patients  
6 November 2019 Alert Medicine Consumer level recall of one lot of Avonex Pen 30mcg in 0.5mL, Lot 1422362  
21 October 2019 Alert Medicine Medicines containing ranitidine and a potential impurity, N-nitrosodimethylamine (NDMA)  
21 October 2019 Monitoring Medicine Losartan approved medicines supplied in New Zealand not affected by recalls overseas  
21 October 2019 Monitoring Medicine Review of chemically synthesised active pharmaceutical ingredients for presence of nitrosamine impurity  
11 October 2019 Alert Medicine Medsafe is issuing a warning that Valentus SlimROAST Optimum Dark Roast Coffee should not be consumed – statement under section 98 of the Medicines Act 1981  
23 September 2019 Alert Medicine Medicines containing ranitidine and a potential impurity, N-nitrosodimethylamine (NDMA)  
19 September 2019 Monitoring Medicine Update - M² Logo Possible risk of lichen planus or lichenoid drug eruption with zoster (shingles) vaccine or influenza vaccine  
16 August 2019 Monitoring Medicine Cathejell Lignocaine 2% Gel and reports of issues when using this medicine  
9 August 2019 Monitoring Medicine M² Logo Tramadol and opioid effects in breastfeeding babies – monitoring extended to 30 November 2019 8 January 2020
1 August 2019 Alert Medicine Medsafe is issuing a warning to consumers to stop taking Go Lean Detox and Go Detox – statement under section 98 of the Medicines Act 1981
31 July 2019 Monitoring Device Update - Breast Implants and anaplastic large cell lymphoma  
30 May 2019 Alert Medicine Take care when prescribing and dispensing levodopa-containing products (Madopar, Sinemet, Kinson)  
16 May 2019 Monitoring Medicine M² Logo Risk of infections with Prolia (denosumab) 8 January 2020
24 April 2019 Monitoring Medicine Review of the risks of harm and chance of benefit of Cafergot (ergotamine tartrate + caffeine) under section 36 of the Medicines Act 1981  
24 April 2019 Alert Medicine Take care when prescribing and dispensing levodopa-containing products (Madopar, Sinemet, Kinson)  
Updated: 23 April 2019
18 April 2019
Alert Medicine Consumer Level Recall – Baby Teething Powder & Baby Colic Powder  
16 April 2019 Alert Medicine Hydrochlorothiazide: risk of non-melanoma skin cancer  
22 March 2019 Alert Device Consumer Level Recall – Normal Saline, a component of The Trusts First Aid Kits  
6 March 2019 Monitoring Medicine Losartan approved medicines supplied in New Zealand not affected by recalls overseas  
4 March 2019 Alert Medicine Use of sodium valproate (Epilim) in girls and women – Change to indications and contraindications  
11 February 2019 Alert Medicine Consumer Level Recall – Bronchi-Cough Pills (Qiguanyan Kesou Tanchuanwan)  
4 February 2019 Alert Device Recall and Hazard Alert: Medtronic Adapta Dual Chamber Pacemaker  

2018

Publication date Communication Product Type Topic Update date
13 December 2018 Monitoring Medicine M² Logo Tramadol and opioid effects in breastfeeding babies  
27 November 2018 Alert Medicine Artemisia annua (Sweet wormwood, Sweet Annie, Qing hao) extract marketed as Arthrem: risk of harm to the liver – statement under section 98 of the Medicines Act 1981  
26 October 2018 Monitoring Medicine M² Logo Possible risk of lichen planus or lichenoid drug eruption with zoster (shingles) vaccine or influenza vaccine  
5 September 2018 Alert Device The USFDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication  
14 August 2018 Monitoring Medicine M² Logo Isotretinoin and Obsessive Compulsive Disorder (OCD) 9 December 2019
13 August 2018 Alert Medicine Codeine – new restrictions on use in children and young adults  
6 August 2018 Monitoring Medicine Dolutegravir and the possible risk of neural tube defects when taken early in pregnancy  
27 July 2018 Alert Medicine Consumer Level Recall - Melatonin 3mg tablets  
9 May 2018 Monitoring Medicine Life-threatening severe allergic reaction (anaphylaxis) to Calocurb dietary supplement  
30 April 2018 Monitoring Medicine Beware turmeric/curcumin containing products can interact with warfarin  
18 April 2018 Alert Medicine Consumer Level Recall - Apo-Primidone 250mg tablets  
15 February Alert Medicine Arthrem – potential risk of harm to the liver – statement under section 98 of the Medicines Act 1981 27 November 2018
9 February Alert Device UPDATE - Heater-cooler devices used during cardiac surgery: risk of infection with Nontuberculous Mycobacterium species – advice and recommendations  
31 January Monitoring Medicine Update to Viekira Pak and Viekira Pak-RBV – Possible effects on blood glucose control when used in patients with type 2 diabetes  
31 January Monitoring Medicine Dabigatran and gout or gout-like symptoms 25 September 2018

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2017

Publication date Communication Product Type Topic Update date
13 December Alert Device Surgical Mesh Implants - Update  
5 December Monitoring Medicine M² Logo Update - Possible risk of hypothyroidism in infants exposed to iodine-containing contrast agents  
22 September Alert Medicine Consumer Level Recall - Maxiclear Sinus & Pain Relief and Maxiclear Cold & Flu Relief  
25 August Monitoring Medicine Watch out for INR changes when direct-acting antivirals (DAAs) are used concomitantly with warfarin  
21 August Alert Medicine Gadolinium based contrast agents for MRI and retention of gadolinium in the brain  
11 July Alert Device Update - Heater-cooler units used during cardiac surgery: risk of infection with Nontuberculous Mycobacterium species – advice and recommendations Jan/Feb 2018
7 July Alert Medicine Use of Tramadol During Breastfeeding  
12 May Monitoring Medicine Direct-acting antiviral (DAA) regimens and liver failure  
24 March Alert Medicine Andrographis paniculata – potential risk for allergic reactions  
24 March Monitoring Device Animas Vibe Insulin Pump and Blood Glucose Analyser - ongoing issues with screen fade, cracked battery casing and other issues.  
13 March Monitoring Medicine M² Logo Viekira Pak and Viekira Pak-RBV – Possible effects on blood glucose control when used in patients with type 2 diabetes 31 January 2018
22 March Alert Medicine Consumer Level Recall - EpiPen® (Adrenaline) 300 micrograms (mcg) Auto-Injector  
2 March Monitoring Medicine M² Logo Possible risk of hypothyroidism in infants exposed to iodine-containing contrast agents added to the medicines monitoring scheme 5 December 2017
7 February Monitoring Medicine M² Logo Update - Rivaroxaban, dabigatran and apixaban and possible risk of hair loss (alopecia)  

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2016

Publication date Communication Product Type Topic Update date
23 December Alert Device Consumer Level Recall – Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling used for patient hoists  
7 December Monitoring Device Update - EasyCheck hCG Urine Pregnancy Test Cassette – Invalid (Negative) and Inconclusive Results  
September Other Device Adverse Event Reports Relating to Surgical Mesh Implants (PDF 300 KB, 24 pages)  
9 September Alert Medicine Consumer Level Recall – GlucaGen® HypoKit 1 mg solution for injection  
31 August Alert Device Heater-cooler devices used during cardiac surgery: risk of infection with Nontuberculous Mycobacterium species – advice and recommendations 11 July 2017
29 August Alert Device Detachable Wall Plug for AC Power Adapter supplied with Medela Breast Pump Powered  
1 August Alert Device Quickie Q7 Wheelchair (Model ER14) manufactured between 1 September 2009 & 27 November 2013. (Backrest Bracket Damage)  
30 May Monitoring Medicine M² Logo Rivaroxaban, dabigatran and apixaban and possible risk of hair loss (alopecia) added to the medicines monitoring scheme 7 February 2017
26 May Monitoring Device Apex e-chamber spacer device - user issues with valve and round mouthpiece  
26 May Monitoring Device EasyCheck hCG Urine Pregnancy Test Cassette – Invalid (Negative) and Inconclusive Results 7 December 2016
3 March Monitoring Medicine Influenza vaccine and mild hypersensitivity reactions  
2 March Alert Medicine Vit.D3 – important information for patients with a peanut or soya allergy  
1 March Monitoring Medicine M² Logo Ticagrelor (Brilinta) and a possible association with depression / suicidality added to the Medicine Monitoring scheme 17 October 2016
11 February Monitoring Medicine M² Logo Update - Melatonin and Hallucinations  
Up to 2016 Monitoring Medicine M² Logo Medicines Monitoring Archive  
Up to 2016 Monitoring Medicine M² Logo Medicines Monitoring outcomes  

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2015

Publication date Communication Product Type Topic Update date
9 November Monitoring Medicine M² Logo Update - Guaifenesin (guaiphenesin) and possible risk of tinnitus  
28 September Alert Medicine Use of sodium valproate (Epilim) in pregnancy  
25 September Alert Device Devices manufactured by Silimed, Brazil  
31 July Alert Medicine Advice about Serotonin Syndrome  
20 July Monitoring Medicine M² Logo Melatonin and Hallucinations added to the medicines monitoring scheme 11 February 2016
22 June Monitoring Medicine Influenza vaccine and mild hypersensitivity reactions 3 March 2016
19 June Alert Medicine Miracle Mineral Solution - Buyer Beware  
17 June Alert Medicine Ibuprofen and Cardiovascular Safety  
22 May Monitoring Medicine M² Logo Update - Zoledronic acid and possible risk of tendon injury/tendinitis  
29 April Alert Medicine Changes to the use of bromhexine or codeine-containing cough and cold medicines in children  
7 April Monitoring Medicine Guaifenesin (guaiphenesin) and possible risk of tinnitus added to the medicines monitoring scheme 9 November 2015
9 February Monitoring Medicine M² Logo Update - Bisphosphonates and possible risk of optic neuritis  

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2014

Publication date Communication Product Type Topic Update date
22 December Alert Medicine Domperidone (Motilium, Prokinex) – conclusion of review of benefits and risks of harm  
21 November Monitoring Medicine M² Logo Update - Allopurinol and lichenoid-type skin reactions  
21 November Monitoring Medicine M² Logo Update - Doxazosin and a possible risk of nightmare (paroniria)  
7 November Monitoring Medicine Ethics Enalapril 5mg tablets - Difficulty in halving tablets  
20 October Monitoring Medicine M² Logo Zoledronic acid and possible risk of tendon injury/tendinitis added to the medicines monitoring scheme 22 May 2015
13 October Monitoring Medicine Reduced adhesion and efficacy noted by some patients using Mylan Fentanyl Transdermal patches  
9 September Monitoring Medicine M² Logo Update - Amitriptyline and a possible risk of peripheral coldness (cold hands and/or feet) or Raynaud's phenomenon  
9 September Monitoring Medicine M² Logo Update - Ornidazole and adverse effects on the eye  
1 August Monitoring Medicine M² Logo Update - Statins and a possible risk of acute kidney injury (without rhabdomyolysis)  
21 July Monitoring Medicine Update - Provive MCT - LCT 1% Emulsion for Injection (10mg/mL) and Provive 1% Emulsion for Injection (10mg/mL) - investigation of infection in Australia  
17 July Alert Medicine CONSUMER LEVEL RECALL - Amoxicillin Actavis Powder for oral suspension; glass fragments found in two bottles  
16 July Alert Medicine Hydroxyethyl starch (Voluven and Volulyte 6%) – review of benefits and risks of harm  
11 July Monitoring Medicine M² Logo Bisphosphonates and possible risk of optic neuritis added to the medicines monitoring scheme 9 February 2015
28 May Monitoring Medicine M² Logo Update - Champix (varenicline) and a possible interaction with alcohol based on post-marketing reports  
16 May Monitoring Device Cook Petite Vital Port, adherence of tubing to the vessel wall leading to complications in explanting the device  
5 May Monitoring Medicine Provive MCT - LCT 1% Emulsion for Injection (10mg/mL) and Provive 1% Emulsion for Injection (10mg/mL) - investigation of infection in Australia 21 July 2014
9 April Monitoring Medicine M² Logo Allopurinol and lichenoid-type skin reactions added to the medicines monitoring scheme 21 November 2014
1 April Monitoring Medicine M² Logo Doxazosin and a possible risk of nightmare (paroniria) added to the medicines monitoring scheme 21 November 2014
31 March Monitoring Medicine Domperidone (Motilium, Prokinex) and effects on the heart  
14 March Alert Medicine Update - m-Captopril tablets 12.5mg, 25mg, 50mg, 100mg - Manufacturing Issues  
27 February Monitoring Medicine Effectiveness of emergency contraception may be reduced in women weighing more than 70kg  
11 February Alert Medicine Utrogestan (progesterone) formulation change - important information for patients with a peanut allergy  
3 February Monitoring Medicine M² Logo Amitriptyline and a possible risk of peripheral coldness (cold hands and/or feet) or Raynaud's phenomenon added to the medicines monitoring scheme 9 September 2014

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2013

Publication date Communication Product Type Topic Update date
3 December Alert Medicine Black salve - buyer beware  
12 November Monitoring Medicine UPDATE: Hydroxyethyl starch solutions (Voluven, Volulyte 6%) associated with increased risk of mortality and renal impairment 16 July 2014
12 November Alert Medicine Discontinuation of oral ketoconazole (Nizoral) 200mg tablets  
11 November Alert Medicine m-Captopril tablets 12.5mg, 25mg, 50mg, 100mg - Manufacturing Issues 14 March 2014
1 November Monitoring Medicine M² Logo Ornidazole and adverse effects on the eye 9 September 2014
1 November Monitoring Medicine M² Logo Statins and a possible risk of acute kidney injury (without rhabdomyolysis) 1 August 2014
4 October Alert Medicine Pradaxa (dabigatran etexilate) and oesophageal ulcer  
8 July Monitoring Medicine Hydroxyethyl starch solutions (Voluven, Volulyte 6%) associated with increased risk of mortality and renal impairment 12 November 2013
8 July Alert Medicine Diclofenac (Voltaren) and risk of cardiovascular events (heart attack and stroke)  
17 June Monitoring Medicine M² Logo Champix (varenicline) and a possible interaction with alcohol based on post-marketing reports 28 May 2014
4 June Alert Device Topical tissue glues/adhesives and risk of deep tissue injuries  
January Monitoring Medicine Update on Pradaxa (dabigatran etexilate)  

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2010 - 2012

Publication date Topic
17 April 2012 Management of Patients with Metal on Metal Hip Implants
March 2012 Update on Pradaxa (dabigatran etexilate)
31 October 2011 Pradaxa (dabigatran etexilate): Questions and Answers
24 August 2011 Vaccine adverse event information to be released to the Health Select Committee (PDF document, 112 KB, 12 pages)
17 February 2011 Questions and Answers on rosiglitazone (Avandia)
11 October 2010 Withdrawal of Sibutramine (Reductil) in New Zealand
9 June 2010 Graseby MS-Series Syringe Drivers - Further Extension of Deadline

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2005 - 2009

Publication date Topic
3 December 2009 Withdrawal of Dextropropoxyphene-containing Medicines
1 December 2009 Graseby MS-Series Syringe Drivers - Extension of Deadline
November 2009 Eltroxin Formulation Change
October 2009 Use of Cough and Cold Medicines in Children - Updated advice
August 2009 Electronic Reporting Tool for Pharmacovigilance Activities
23 March 2009 Infusion Device Safety Software
2 March 2009 Graseby MS-Series Syringe Drivers
26 June 2008 Eltroxin formulation change - Monitor patients and adjust dosing if necessary
September 2008 Paracetamol Associated with Asthma Symptoms
19 March 2008 Reporting of Incidents involving Active Implantable Devices and their Accessories
1 February 2008 Anti-epileptics - Monitor patients for increased risk of suicidality
30 January 2008 Syringe Driver Advisory Group (SDA)
13 December 2007 Use of Cough and cold products in children under 2 years of age
23 November 2007 Discontinuation of supply of Graseby MS16A and MS26 syringe drivers
26 October 2007 Aprotinin - Increased caution is warranted
27 September 2007 Medsafe receives more toothpaste testing results
16 December 2005 Malfunction of a Cryosurgical Instrument
29 April 2005 Prescribing Restrictions for all COX-2 Inhibitors
28 February 2005 Product Alert - Monofeme and Monofeme 28
22 February 2005 Medsafe advises review of all patients on COX-2 inhibitors

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2000 - 2004

Publication date Topic
15 October 2002 The Use of Alcohol Based Skin Preparations in Operating Theatres
19 June 2002 Herbal Supplements Warning from Health Canada
22 November 2000 Finger Pricking Devices - Important Notice

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1990s

Publication date Topic
July 1999 Amalgam and other Dental Filling Materials
November 1994 Silicone Gel Breast Implants
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