Revised: 13 March 2024
Safety Information
Dear Healthcare Professional Letters
This section provides copies of letters sent to healthcare professionals by the therapeutic products industry. These letters detail possible safety or quality concerns, they are published here on behalf of the industry. These letters are provided voluntarily and this section may not be comprehensive.
| Date sent | Product | Reason |
|---|---|---|
| 5 March 2024 | Dexmedetomidine Viatris (PDF, 1 page, 204KB) | Due to a shortage of Dexmedetomidine Viatris 200 mcg/2 mL, concentrate for infusion a labelling exemption has been approved by Medsafe to allow the supply of Dexmedetomidine Mylan 200 mcg/2 mL, concentrate for infusion from Australia. |
| 5 March 2024 | Rocuronium bromide (Hameln) (PDF, 3 pages, 427KB) | Supply of Croatian/Slovenian labelled Rocuronium bromide (Hameln) Solution for injection 10 mg/mL |
| February 2024 | Coversyl (PDF, 4 pages, 457KB) | Changes to Coversyl 4mg tablet appearance and Changes to Coversyl packaging |
| 23 January 2024 | Paxlovid (PDF, 7 pages, 630KB) | Transition to New Zealand packaging, updates to the contraindications section of the data sheet and dosing instructions for patients with renal impairment’ |
| 28 November 2023 | Epilim (PDF, 2 pages, 179KB) | Potential risk to children of fathers treated with valproate - Updated information regarding risk of neurodevelopmental disorders including autism spectrum disorders after paternal exposure to valproate in comparison to lamotrigine/levetiracetam |
| 10 August 2023 | Estradiol (PDF, 3 pages, 506KB) | Estradiol Transdermal Patches (Mylan) – Alternative Registered Carton |
| 4 July 2023 | Estradiol (PDF, 3 pages, 180KB) | Estradiol Transdermal Patches (Mylan) previously supplied under Section 29 |
| 6 June 2023 | Fentanyl Sandoz (PDF, 4 pages, 260KB) | Product Labelling and Data Sheet updates – Fentanyl Sandoz Transdermal patch |
| 30 May 2023 | Epilim (PDF, 2 pages, 157KB) | Sodium valproate (Epilim) use in people who can father children: important new safety information |
| 6 April 2023 | Topamax (PDF, 4 pages, 232KB) | Topiramate use in pregnancy: further restrictions for safety |
| 24 February 2023 | Lageviro (PDF, 2 pages, 223KB) | Lagevrio® molnupiravir 200 mg Capsules Extension to Shelf Life of Stock in Market |
| 24 January 2023 | Paxlovid (PDF, 3 pages, 193KB) | Shelf life extension of Paxlovid® (nirmatrelvir 150 mg/ritonavir 100 mg), film coated tablets, TT50-10969 |
| 6 February 2023 | Dexmedetomidine (PDF, 3 pages, 835KB) | Increased risk of mortality in intensive care unit (ICU) patients ≤63.7 years |
| 7 November 2022 | Setrona (PDF, 2 pages, 415KB) | Supply of Australian-labelled Setrona 100 mg tablets in New Zealand |
| 3 November 2022 | Imbruvica (PDF, 3 pages, 333KB) | Data Sheet Updates to Dose Modifications for Adverse Reactions and to Warnings and Precautions |
| 20 June 2022 | Comirnaty (PDF, 2 pages, 813 KB) | Presentations available in New Zealand |
| 9 June 2022 | Coversyl (PDF, 3 pages, 260 KB) | Supply of Canadian-labelled Coversyl 2 mg, 4 mg and 8 mg perindopril erbumine tablets in New Zealand |
| 10 May 2022 | Motetis (tetrabenazine), (PDF, 169 KB, 1 page) | Change in appearance of Motetis 25 mg tablets |
| 14 April 2022 | Lagevrio (molnupiravir), (PDF 412 KB, 4 pages) | Important safety information regarding the usage of Lagevrio |
| 5 April 2022 | PAXLOVID (nirmatrelvir 150 mg/ritonavir 100 mg), film coated tablets (PDF, 292 KB, 5 pages) | Supply of PAXLOVID (nirmatrelvir 150 mg/ritonavir 100 mg), film coated tablets |
| 29 March 2022 | ClopineCENTRAL™ (PDF, 168 KB, 2 pages) | New improvements occurring on the ClopineCENTRAL™ website effective 28th of March 2022 |
| 24 February 2022 | NUVAXOVID (COVID-19 Vaccine with Matrix-M Adjuvant) (PDF, 222 KB, 1 page) | Supply of NUVAXOVID COVID-19 Vaccine in New Zealand |
| 31 January 2022 | Ronapreve (casirivimab and imdevimab) (PDF, 217 KB, 3 pages) | Ronapreve solution for injection or infusion 120 mg/mL; reduced neutralisation activity of the antibody combination against the full-length S protein of the Omicron variant of COVID-19 |
| 24 December 2021 | Ronapreve (casirivimab and imdevimab) (PDF, 362 KB, 3 pages) | Important information about Ronapreve supplied in New Zealand. |
| 22 December 2021 | Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech) | Supply of new formulation of Comirnaty (COVID-19 Vaccine) in New Zealand |
| 6 December 2021 | Cuprior (trientine) (PDF, 265 KB, 2 pages) | Labelling exemption - Cuprior 150mg film-coated tablet |
| 3 December 2021 | Alecensa(alectinib) (PDF, 243 KB, 2 pages) | Warnings and precautions and specific dose modification guidance for management of haemolytic anaemia |
| 22 November 2021 | AstraZeneca and Janssen COVID-19 vaccines (PDF, 291 KB, 3 pages) | Distinguishing between Thrombosis and Thrombosis with Thrombocytopenia (TTS) following COVID-19 vaccinations |
| 18 November 2021 | Tenecteplase (PDF, 2 pages, 373 KB) | Update on tenecteplase supply shortage |
| 17 November 2021 | COVID-19 Vaccine AstraZeneca (PDF, 3 pages, 215 KB) | Supply of COVID-19 Vaccine AstraZeneca in New Zealand |
| 21 October 2021 | Actemra (PDF, 4 pages, 753 KB) | Supply of Actemra (tocilizumab) 162 mg/0.9 mL solution for subcutaneous |
| 11 October 2021 | Actemra (PDF, 4 pages, 753 KB) | Supply of Actemra (tocilizumab) for hospital use |
| 6 September 2021 | Actemra (PDF, 2 pages, 215 KB) | Notification of temporary supply shortage for Actemra (tocilizumab) |
| 12 July 2021 | Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech) (PDF, 13 pages, 620 KB) | Supply of Comirnaty COVID-19 Vaccine in New Zealand |
| 17 May 2021 | Novatretin (PDF, 2 pages, 598 KB) | Increase in period during which effective contraception must be used has increased from two to three years and important information about blood donations |
| 17 May 2021 | Engerix-B (PDF, 3 pages, 209 KB) | Supply of Engerix-B paediatric vaccine 10 mcg/0.5ml (Hepatitis B vaccine) – Australian pack |
| 13 April 2021 | Influenza Vaccines (PDF, 2 pages, 259 KB) | Important information: Influenza vaccines for SH2021 |
| 28 March 2021 | Macrobid (PDF, 2 pages, 242 KB) | Macrobid modified-release capsule release characteristics and in-use shelf life |
| 23 March 2021 | Priorix (PDF, 2 pages, 319 KB) | Priorix vaccine will be supplied as a single-dose in a Singapore pack. |
| 15 March 2021 | Veracloz (PDF, 1 page, 177 KB) | Clopine 50 mg/mL oral suspension brand is being replaced by Versacloz 50 mg/mL oral suspension |
| 14 February 2021 | Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech) (PDF, 9 pages, 2.07 MB) | Supply of Comirnaty COVID-19 Vaccine in New Zealand |
| 28 January 2021 | Tenecteplase (PDF, 2 pages, 316 KB) | Tenecteplase supply shortage |
| 13 January 2021 | Clopine (PDF, 1 page, 94 KB) | Clopine Central Database: Updated blood monitoring threshold levels and its impact on colour coding has been delayed |
| 14 December 2020 | Metalyse (PDF, 2 pages, 128 KB) | Temporary Medicine Shortage of Metalyse (tenecteplase) |
| 14 December 2020 | Clopine (PDF, 1 page, 108 KB) | Clopine Central Database: Updated blood monitoring threshold levels and its impact on colour coding has been delayed |
| 16 November 2020 | Minirin (PDF, 2 pages, 270 KB) | Letter to Pharmacist – Notification of shortage of Minirin (desmopressin acetate) nasal drops |
| 16 November 2020 | Minirin (PDF, 2 pages, 268 KB) | Letter to Prescriber – Notification of shortage of Minirin (desmopressin acetate) nasal drops |
| 11 November 2020 | Lyrica (PDF, 2 pages, 149 KB) | Supply of Australian-labelled Lyrica (pregabalin) 150 mg capsules in New Zealand |
| 9 November 2020 | Tecentriq (PDF, 2 pages, 215 KB) |
Tecentriq® (atezolizumab), Identified Risk of Severe Cutaneous
Adverse Reactions (SCARs) Correction note (PDF, 1 page, 147 KB) |
| 5 November 2020 | Engerix-B (Paediatric) (PDF, 3 pages, 244 KB) | Supply of Engerix-B paediatric vaccine 10 mcg/0.5ml (Hepatitis B Vaccine) – Australian pack |
| 1 October 2020 | Norimin/Brevinor-1 28 Day (PDF, 1 page, 58 KB) | Notification of temporary disruption to product supply |
| 4 September 2020 | Setrona (PDF, 2 pages, 757 KB) | Supply of Australian-labelled Setrona 50 mg and 100 mg tablets in New Zealand |
| 18 August 2020 | Brevinor 28 Day (Australian Stock) (PDF, 1 page, 158 KB) | Temporary alternative product supply to cover Norimin stock shortage |
| 16 June 2020 | Tramal (PDF, 2 pages, 597 KB) | Tramal (tramadol) data sheet safety update to precautions and contraindications |
| 27 May 2020 | Microlut (PDF, 2 pages, 380 KB) | Reason: Supply of Australian labelled Microlut to New Zealand |
| 28 April 2020 | Plaquenil (PDF, 4 pages, 358 KB) | Use of Hydroxychloroquine [Plaquenil®] in the context of COVID 19 – Risk of QT prolongation and drug/drug interactions |
| 1 April 2020 | Typhim Vi (PDF, 2 pages, 680 KB) | Supply of Typhim Vi under labelling exemption |
| 1 April 2020 | Reopro (PDF, 2 pages, 78 KB) | Discontinuation of Reopro (abciximab) 10mg/5mL solution for injection vials as of 30 June 2020 - information for healthcare professionals |
| 12 February 2020 | Nozinan (Swiss Stock) (PDF 299 KB, 2 pages) | Change in supply of Nozinan (levomepromazine) tablets to product sourced from Switzerland - information for healthcare professionals |
| 7 February 2020 | Nozinan (Swiss Stock) (PDF 233 KB, 1 page) | Change in supply of Nozinan (levomepromazine) tablets to product sourced from Switzerland - information for patients |
| 21 January 2020 | Gardasil 9 (PDF 43 KB, 1 page) | Issue with 'tear-off' labels for Gardasil 9 vaccine |
| 14 January 2020 | Accuretic (PDF 490 KB, 2 pages) | Supply of Accuretic 10mg/12.5mg tablets in alternative (Canadian) artwork to New Zealand |
| 18 December 2019 | Xiaflex (PDF 128 KB, 1 page) | Xiaflex (collagenase clostridium histolyticum) product approval lapse on 31 March 2020 |
| 17 December 2019 | Tivicay and dolutegravir containing regimens (PDF 134 KB, 2 pages) | Updated information on neural tube defects reported in Tsepamo Study, Botswana |
| 27 November 2019 |
Kadycla (PDF 128 KB, 2 pages) |
Important Kadcyla® (trastuzumab emtansine) Safety Communication: Potential Risk for Medication Error Between Kadcyla® and Herceptin® (trastuzumab) |
| 25 November 2019 |
Esbriet (pirfenidone) (PDF 334 KB, 3 pages) |
Important Safety Update on Esbriet (pirfenidone) and Drug-Induced Liver Injury (DILI) |
| 25 September 2019 | MMR II Vaccine (PDF 501 KB, 4 pages) | Additional supply of MMR II measles, mumps and rubella vaccine: differences in labelling and package inserts |
| 9 August 2019 | Femme-Tab (PDF 174 KB, 1 page) | In light of recent shortage of Combined Oral Contraceptive products, Microgynon® (Bayer) and Levlen® (Bayer) in New Zealand, Femme-Tab ED 20/100 (Ethinyloestradiol 20 mcg + Levonorgestrel 100 mcg) and Femme-Tab ED 30/150 (Ethinyloestradiol 30 mcg + Levonorgestrel 150 mcg) have been available from 17 July 2019 |
| 17 July 2019 | Ranbaxy-Cefaclor (PDF 222 KB , 1 page) | Supply disruption for Cefaclor oral suspension and Acarbose tablets: difference in reconstitution volume for Keflor granules |
| 3 July 2019 | FluQuadri (PDF 109 KB, 2 pages) | Additional supply of FluQuadri influenza vaccine: differences in labelling and package inserts |
| 13 June 2019 | Tecentriq (PDF 649 KB, 2 pages) | Notification of Immune-related Myositis as new Important Identified Risk for Tecentriq |
| 11 June 2019 | Xiaflex (PDF 231 KB, 2 pages | Xiaflex® (collagenase clostridium histolyticum) product discontinuation from 28 June 2019 |
| 7 May 2019 | Actemra (PDF 361 KB, 3 pages) | New important identified risk: Hepatoxicity |
| 26 March 2019 | Darzalex (PDF 103 KB, 2 pages) | New important identified risk: Hepatitis B Reactivation |
| 15 February 2019 | Esmya (PDF 115 KB, 2 pages) | Important safety update following reports of serious liver injury |
| 21 December 2018 | Epilim (PDF 68 KB, 1 page) | Updated educational materials for use in women of child-bearing potential |
| 5 December 2018 | Tecentriq (PDF 501, 2 pages) | Revision of indication for treatment of locally advanced or metastatic urothelial carcinoma |
| 5 December 2018 | Tecentriq (PDF 645 KB, 2 pages) | New important identified risk: Nephritis |
| 27 September | Coaguchek (PDF 559 KB, 8 pages) | Roche reconfirms their recommendation that Coaguchek INR results above 4.5, from lots specified in the attached notification, are confirmed with a laboratory method. |
| 25 September 2018 | Volulyte and Voluven (PDF 821 KB, 2 pages) | Safety information update |
| 20 August 2018 | Dilantin (PDF 209 KB, 2 Pages) | Clarification regarding Dilantin Dear Healthcare Professional Letter dated 19 July 2018 |
| 13 August 2018 | Bicillin (PDF 1,135 KB, 4 Pages) | Changes to expression of product strength |
| 6 August 2018 | Tivicay (PDF 87 KB, 3 Pages) | Tivicay (dolutegravir): neural tube defects reported in Tsepamo Study, Botswana |
| 19 July 2018 | Dilantin (PDF 91 KB, 2 Pages) | Dissolution profile of Dilantin® 30 mg and 100 mg capsules (New Formulation) |
| 3 July 2018 | Neulactil (PDF 78 KB, 2 pages) | Provisional Consent of Neulactil periciazine 2.5mg and 10mg tablets (Hong Kong stock) to cover temporary stock shortage |
| 5 December 2017 | Ofev (PDF 1052 KB, 2 pages) | Information on severe liver injury in patients with idiopathic pulmonary fibrosis |
| 3 August 2017 | Tecentriq (PDF 70 KB, 2 pages) | Severe cases of myocarditis |
| 27 March 2017 | Zelboraf (PDF 98KB, 2 pages) | Risk of Dupuytren's Contracture and Plantar Fascial Fibromatosis |
| 14 December 2016 | Erivedge (PDF 110 KB, 2 pages) | Extension of Pregnancy Prevention Duration for Women of Childbearing Potential and Interval before Blood Donation and Lactation |
| 15 August 2016 | Noxafil (PDF 212 KB, 2 pages) | Posaconazole tablets and oral suspension are not interchangeable |
| 2 June 2016 | Erivedge (PDF 111 KB, 2 pages) | Risk of premature epiphyseal fusion |
| 24 May 2016 | Invokana (PDF 71 KB, 2 pages) | Advice on the risk of lower limb amputations primarily of the toe during treatment with canagliflozin |
| 8 December 2015 | Cellcept (PDF 100 KB, 3 pages) | New restrictions on use due to teratogenic risk |
| 1 December 2015 | Tarceva (PDF 91 KB, 2 pages) | Indication restricted to EGFR-activating mutations only |
| 9 July 2015 | Forxiga (PDF 28 KB, 2 pages) | Risk of ketoacidosis |
| 29 April 2015 | Motilium (PDF 344 KB, 1 page) | New recommendations to minimise cardiac risks |
| 8 December 2014 | Reminyl (PDF 669 KB, 1 page) | Serious skin reactions |
| 26 November 2014 | Dilatrend tablets (PDF 335 KB, 2 pages) | Severe cutaneous adverse reactions |
| 5 August 2014 | Cal.D. Forte tablets (PDF 310 KB, 1 page) | Update on stability issues |
| 5 August 2014 | Topamax tablets (PDF 142 KB, 1 page) | Additional warnings and precautions - Visual field defects |
| 4 August 2014 | Concerta tablets (PDF 181 KB, 1 page) | Additional precaution - Priapism |
| 1 July 2014 | Bacillus Calmette-Guerin (BCG) vaccine (PDF 304 KB, 2 pages) | Supply of unapproved medicine under S29 of the Medicines Act |
| 20 May 2014 | Piportil depot Injection (PDF 34 KB, 1 page) | Update to supply issues |
| 17 January 2003 | Traditional Chinese Medicines | Products containing toxic substances and prescription medicines |
| 14 December 2001 | Cheng Kum/Shen Loon | Betamethasone found in herbal medicine capsules |
