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Archive of safety communications
The history of safety communicatons – Early Warning System

Archive of safety communications

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 Please note that the information contained in these communications may have been superseded.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.

1990s
2000-2004
2005-2009
2010-2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023

2024

Publication date	Communication	Product Type	Topic	Update date
16 October 2024	Monitoring	Medicine	Update - Calcium channel blockers and the possible risk of new-onset eczema
8 August 2024	Monitoring	Medicine	Direct acting oral anticoagulants and potential for patients to experience mood changes (monitoring closes February 2025)	14 April 2025
9 July 2024	Monitoring	Medicine	DPP-4 inhibitors and the possible risk of ileus
13 May 2024	Alert	Medicine	Promethazine (oral): Do not use in children under 6 years of age due to the risk of psychiatric and central nervous system side effects
8 April 2024	Alert	Medicine	Do not use NaturaCoco Moisturising Cream or Dok Apo Moisturiser Soothing Cream
8 April 2024	Monitoring	Medicine	Calcium channel blockers and the possible risk of new-onset eczema	16 October 2024
4 March 2024	Alert	Medicine	Recent cases of lead poisoning with Ayurvedic Medicines
15 January 2024	Monitoring	Medicine	DPP-4 inhibitors and the possible risk of ileus	9 July 2024

2023

Publication date	Communication	Product Type	Topic	Update date
7 December 2023	Alert	Medicine	Update - Sodium valproate (Epilim) use in people who can father children: important new safety information
20 November 2023	Monitoring	Medicine	Update - Interleukin inhibitors and the possible risk of pancreatitis
25 September 2023	Alert	Medicine	Consent to distribute pholcodine-containing medicines will be revoked on 12 January 2024
4 September 2023	Alert	Medicine	Processing of adverse event reports received in New Zealand
19 June 2023	Monitoring	Medicine	Update - Possible risk of seizures with clonidine
30 May 2023	Alert	Medicine	Sodium valproate (Epilim) use in people who can father children: important new safety information	7 December 2023
10 May 2023	Monitoring	Medicine	Interleukin inhibitors and the possible risk of pancreatitis
26 April 2023	Monitoring	Medicine	Review of pholcodine-containing medicines – Provide your feedback by 8 May 2023	25 September 2023
6 April 2023	Alert	Medicine	Topiramate use in pregnancy: further restrictions for safety
27 March 2023	Monitoring	Medicine	Update - Abnormal uterine bleeding and oral anticoagulants (blood thinners)
20 March 2023	Alert	Medicine	New legislation about medicines that can impair driving
2 March 2023	Monitoring	Medicine	Reports of pericarditis following mpox vaccination

2022

Publication date	Communication	Product Type	Topic	Update date
28 November 2022	Monitoring	Medicine	Possible risk of seizures with clonidine	19 June 2023
22 November 2022	Monitoring	Medicine	Goserelin (Teva) 3.6mg and 10.8 mg implants and reports of issues when administering this medicine
8 September 2022	Alert	Medicine	Myocarditis and pericarditis have been reported with Nuvaxovid (Novavax COVID-19 Vaccine)
5 September 2022	Alert	Device	Recall of KetoSens Test Strips – batch UJ03PBXNG
29 August 2022	Monitoring	Medicine	Update – Possible risk of vasculitis with vildagliptin products (Galvus, Galvumet)
25 August 2022	Monitoring	Medicine	Abnormal uterine bleeding and oral anticoagulants (blood thinners)	27 March 2023
13 July 2022	Alert	Medicine	Medsafe is publishing a warning that the product Nhan Sam Tuyet Lien Truy Phong Hoan should not be consumed
30 June 2022	Alert	Medicine	Accuretic found to contain nitrosamines
7 June 2022	Alert	Device	Typographical error in Healgen Rapid COVID-19 Antigen Self-Test (RATs) patient instruction leaflet
8 April 2022	Alert	Medicine	Reminder: Miracle Mineral Solution has dangerous and potentially life-threatening side effects
22 February 2022	Monitoring	Medicine	Possible risk of vasculitis with vildagliptin products (Galvus, Galvumet)	29 August 2022
20 February 2022	Monitoring	Medicine	Buccaline tablets: review of the benefits and risks under section 36 of the Medicines Act 1981
19 February 2022	Monitoring	Medicine	Update - Pregabalin and the possible risk of bullous dermatitis and exfoliating skin reactions
15 February 2022	Monitoring	Medicine	Update - Dihydrocodeine: review of risks and benefits

2021

Publication date	Communication	Product Type	Topic	Update date
22 December 2021	Alert	Medicine	Medsafe is issuing a warning not to use Goree Beauty Cream with Lycopene, Goree Day and Night Beauty Cream Oil Free, and Golden Pearl Beauty Cream– statement under section 98 of the Medicines Act 1981
17 December 2021	Alert	Medicine	Reminder: Comirnaty vaccination (Pfizer COVID-19 vaccine) can cause myocarditis and pericarditis
17 November 2021	Monitoring	Medicine	COVID-19 vaccination in pregnancy: no safety concerns with Comirnaty (Pfizer COVID-19 vaccine)
17 November 2021	Monitoring	Medicine	Menstrual disorders and unexpected vaginal bleeding – Comirnaty (Pfizer COVID-19 vaccine)
15 November 2021	Alert	Medicine	Consent to distribute medicines containing bufexamac was revoked on 9 November 2021
6 September 2021	Alert	Medicine	Risks of importing or prescribing ivermectin for prevention or treatment of COVID-19
12 August 2021	Monitoring	Medicine	Dihydrocodeine: review of risks and benefits	15 February 2022
21 July 2021	Alert	Medicine	Myocarditis and pericarditis - rare adverse reactions to Comirnaty (Pfizer COVID-19 vaccine)
9 June 2021	Monitoring	Medicines	Myocarditis – a potential adverse reaction to Comirnaty (Pfizer COVID-19 vaccine)
31 May 2021	Monitoring	Medicine	Pregabalin and the possible risk of bullous dermatitis and exfoliating skin reactions	19 February 2022
28 April 2021	Alert	Medicine	Fluad Quad - a newly funded influenza vaccine for people aged 65 years and older
27 April 2021	Monitoring	Medicine	COVID-19 vaccines and rare cases of blood clots with bleeding: no current risk with Comirnarty (Pfizer/ BioNTech) vaccine
7 April 2021	Monitoring	Medicine	UPDATE: Possible risk of psoriasis exacerbation with bupropion
23 March 2021	Monitoring	Medicine	UPDATE: Concern reported with the use of NovoRapid®Penfill® (insulin aspart; 3 mL cartridge) by type 1 diabetes patients
16 March 2021	Alert	Medicine	UPDATE - Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy
2 March 2021	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

2020

Publication date	Communication	Product Type	Topic	Update date
10 December 2020	Monitoring	Medicine	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	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	Update - Possible risk of vasculitis with dabigatran (Pradaxa)
21 May 2020	Monitoring	Medicine	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	Update - Risk of infections with Prolia (denosumab)
8 January 2020	Monitoring	Medicine	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	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	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 - 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	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	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	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	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	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

2017

Publication date	Communication	Product Type	Topic	Update date
13 December	Alert	Device	Surgical Mesh Implants - Update
5 December	Monitoring	Medicine	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	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	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	Update - Rivaroxaban, dabigatran and apixaban and possible risk of hair loss (alopecia)

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	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	Ticagrelor (Brilinta) and a possible association with depression / suicidality added to the Medicine Monitoring scheme	17 October 2016
11 February	Monitoring	Medicine	Update - Melatonin and Hallucinations
Up to 2016	Monitoring	Medicine	Medicines Monitoring Archive
Up to 2016	Monitoring	Medicine	Medicines Monitoring outcomes

2015

Publication date	Communication	Product Type	Topic	Update date
9 November	Monitoring	Medicine	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	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	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	Update - Bisphosphonates and possible risk of optic neuritis

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	Update - Allopurinol and lichenoid-type skin reactions
21 November	Monitoring	Medicine	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	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	Update - Amitriptyline and a possible risk of peripheral coldness (cold hands and/or feet) or Raynaud's phenomenon
9 September	Monitoring	Medicine	Update - Ornidazole and adverse effects on the eye
1 August	Monitoring	Medicine	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	Bisphosphonates and possible risk of optic neuritis added to the medicines monitoring scheme	9 February 2015
28 May	Monitoring	Medicine	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	Allopurinol and lichenoid-type skin reactions added to the medicines monitoring scheme	21 November 2014
1 April	Monitoring	Medicine	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	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

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	Ornidazole and adverse effects on the eye	9 September 2014
1 November	Monitoring	Medicine	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	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)

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

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

2000 - 2004

Publication date	Topic
April 2004	Oral Contraceptives and Hormone Replacement Therapy - Archive 1996 to 2004
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

1990s

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

The history of safety communications – Early Warning System

Medsafe safety communications were initially developed as a joint project with the Australian Therapeutic Goods Administration (TGA) and called the trans-Tasman Early Warning System. Further information on this project can be found in the following links.

Consumers questions and answers on the early warning system

Healthcare professionals questions and answers on the early warning system

Audit of the first 12 months of the early warning system (PDF 350 KB, 14 pages)

Further information on the criteria used by Medsafe to decide when to publish a monitoring communication (PDF 224 KB, 9 pages)