Revised: 4 December 2024

Committees

MARC Reports

As of the 170th meeting held on 8 June 2017, Medsafe will publish the reports presented to the Medicines Adverse Reactions Committee after each meeting. Private and confidential information has been redacted from the reports.

Previous | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023| 2024

2024

199th meeting – 12 September 2024

• 3.2.1 Review of clozapine safety and monitoring requirements: clozapine-induced neutropenia and agranulocytosis (pdf 1.03MB, 100 pages)
• 3.2.2 Use of benzodiazepines for non-epilepsy indications during pregnancy and the risk of miscarriage (pdf 385KB, 24 pages)
• 3.2.3 Anti-CD20 antibodies and pyoderma gangrenosum (pdf 539KB, 46 pages)

198th meeting – 13 June 2024

• 3.2.1 Symmetrical drug-related intertriginous and flexural exanthema (SDRIFE) with systemic antibiotics and systemic antifungals  (pdf 1.06MB, 34 pages)

197th meeting – 14 March 2024

• 3.2.1 Ibuprofen and renal tubular acidosis  (pdf 434KB, 28 pages)

2023

196th meeting – 7 December 2023

• 3.2.1 Direct-acting oral anticoagulants (DOACs) and anticoagulant-related nephropathy (ARN)  (pdf 541KB, 43 pages)
• 3.2.2 Potential drug interaction between estrogen-based hormone replacement therapy and lamotrigine (pdf 333KB, 16 pages)
• 3.2.3 Third generation aromatase inhibitors (AIs) and tendon disorders  (pdf 348KB, 29 pages)
• 3.2.4.Tumour lysis syndrome with tyrosine kinase inhibitors and monoclonal antibodies when used in cancer treatment  (pdf 291KB, 28 pages)

195th meeting – 14 September 2023

• 3.2.1 Oral lidocaine containing products and risks of toxicity in younger children and infants(pdf 4.7MB, 50 pages)
• 3.2.2 DPP-4 inhibitors and GLP-1 receptor agonists and the risk of intestinal obstruction  (pdf 639KB, 33 pages)
• 3.2.3 Acetylcholinesterase inhibitors and the risk QT prolongation and Torsades de Pointes  (pdf 2.4MB, 45 pages)
• 3.2.4 Isotretinoin – psychiatric disorders and sexual dysfunction  (pdf 2.9MB, 40 pages)

194th meeting – 8 June 2023

• Molnupiravir review of efficacy information (pdf 858KB, 34 pages)
• Safety and efficacy of pholcodine (pdf 1.88MB, 52 pages)
• Pericarditis following mpox vaccination (pdf 1.38MB, 18 pages)

193rd meeting – 9 March 2023

• 3.2.1 Interleukin inhibitors and the risk of pancreatitis (pdf 354KB, 28 pages)
• 3.2.2 Probiotics and pre-eclampsia (pdf 413KB, 29 pages)
• 3.2.3 Risk of thromboembolism from vaping- caution with combined oral contraceptive (pdf 371KB, 35 pages)

2022

192nd meeting – 1 December 2022

• 3.2.1 Cephalosporins and neurotoxicity (pdf 2.65MB, 60 pages)
• 3.2.2 Pregabalin and risks in pregnancy (pdf 1.07MB, 24 pages)

191st meeting – 8 September 2022

• 3.2.1 Recent safety signals related to use of Janus kinase inhibitors (pdf 763KB, 61 pages)
• 3.2.2 Cannabidiol, potential drug interaction with systemic mTOR and calcineurin inhibitors (pdf 389KB, 23 pages)
• 3.2.3 Quetiapine and gestational diabetes mellitus (pdf 1070KB, 81 pages)

190th meeting – 9 June 2022

• 3.2.1 Opioids and serotonin syndrome (pdf 942KB, 60 pages)
• 3.2.2 Methylphenidate and the risk of birth defects (pdf 524KB, 32 pages)
• 3.2.3 Prostaglandin associated periorbitopathy (pdf 815KB, 61 pages)
• 3.2.4 Methenamine benefit-risk review (pdf 431KB, 30 pages)

189th meeting – 10 March 2022

• 3.2.1 Glucagon like peptide-1 receptor agonists and drug induced liver injury (pdf 1.15MB, 25 pages)
• 3.2.2 Venlafaxine use in pregnancy (pdf 1.41MB, 45 pages)
• 3.2.3 Safety of non-steroidal anti-inflammatory drug exposure in third trimester of pregnancy (pdf 2.11MB, 31 pages)

2021

188th meeting – 2 December 2021

• 3.1.1 Dihydrocodeine benefit-risk review: referral to the Committee under section 36(2) of the Medicines Act 1981 (pdf 845KB, 69 pages)
• 3.2.1 Benefit-risk review of Buccaline tablets (pdf 356 KB, 15 pages)
• 3.2.2 Tocopherol and risk of bleeding (pdf 413 KB, 32 pages)

187th meeting – 9 September 2021

• 3.2.1 Phentermine risk benefit review
• 3.2.2 Non-steroidal anti-inflammatory drug exposure in 2nd trimester and risk of fetal renal impairment and oligohydramnios

186th meeting - 10 June 2021

• 3.1.1 Consideration of bufexamac medicines under section 36 of the Medicines Act 1981
(pdf 186 KB, 9 pages)
• 3.2.1 Boron-containing excipients and fertility concerns (pdf 938 KB, 20 pages)
• 3.2.2 Misuse of stimulant laxatives (pdf 558 KB, 30 pages)
• 3.2.3 Options for minimising opioid abuse, misuse and dependence (pdf 982 KB, 22 pages)

185th meeting - 11 March 2021

• 3.2.1 SSRI and SNRI antidepressants and the risk of postpartum haemorrhage (pdf 764 KB, 34 pages)
• 3.2.2 Clozapine monitoring frequency and duration (pdf 496 KB, 31 pages)

2020

184th meeting - 3 December 2020

• 3.2.1 Gabapentin and pregabalin safety review
• 3.2.2 Opioids and abuse, misuse and dependence
• 3.2.3 HER2- and CD receptor-targeted monoclonal antibodies and the risk of interstitial lung disease
• 3,2,4 Tricyclic antidepressants and the risk of congenital malformation

183rd meeting - 10 September 2020

• 3.2.1 Macrolides in pregnancy  (pdf 527 KB, 36 pages)
• 3.2.1 Annex 3 NZ National Collections Summary (pdf 108 KB, 4 pages)
• 3.2.2 Domperidone benefit-risk review of use in children under 12 years old  (pdf 324 KB, 28 pages)

182nd meeting - 11 June 2020

• 3.1.1  Consideration of Cathejell (lignocaine) 2% gel under section 36 of the Medicines Act 1981 (pdf 482 KB, 13 pages)
• 3.2.1 Antiepileptic medicines and neurodevelopmental disorders (pdf 736 KB, 46 pages)
• 3.2.2 Fluconazole and use in pregnancy (pdf 654 KB, 32 pages)
• 3.2.3 Use of oral sedating antihistamines in children for sedation (pdf 511 KB, 21 pages)
• 3.2.4 Protease inhibitors for Hepatitis C and risk of serious liver injury (pdf 618 KB, 27 pages)

181st meeting - 12 March 2020

• 3.2.1 Dosing of paracetamol in obese children (pdf 1039 KB, 46 pages)
• 3.2.2 Ondansetron and cleft palate (pdf 752 KB, 35 pages)
• 3.2.2 Annex 6 National Collections Data Summary (pdf 68 KB, 2 pages)
• 3.2.3 Use of Boostrix in pregnancy (pdf 838 KB, 64 pages)

2019

180th meeting - 5 December 2019

• 3.2.1 Pholcodine: benefit-risk review (pdf 757 KB, 54 pages)
• 3.2.2 Direct acting anticoagulants and risk of recurrent thrombotic events (pdf 505 KB, 51 pages)
• 3.2.3 Cyproterone acetate and the risk of hepatic toxicity (pdf 341 KB, 19 pages)
• 3.2.4 Potential drug - drug interaction between capecitabine and proton pump inhibitors (pdf 257 KB, 16 pages)  

179th meeting - 12 September 2019

• 3.1.1 Consideration of Cafergot (ergotamine tartrate + caffeine) under section 36 of the Medicines Act 1981 (pdf 1150 KB, 43 pages) 
• 3.2.1 The use of topiramate during pregnancy for migraine prevention (pdf 1982 KB, 44 pages)
• 3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction (pdf 1642 KB, 29 pages)
• 3.2.3 Dextromethorphan – benefit-risk review (pdf 2286 KB, 50 pages) 
• 3.2.4 Shingrix (recombinant varicella zoster virus vaccine) Risk Management Plan P (pdf 681 KB, 23 pages)

178th meeting - 13 June 2019

• 3.2.1 Use of Trimethoprim in the 65 Years or Older Population (pdf 1064 KB, 34 pages)
• 3.2.2 Carbimazole and Congenital Malformations (pdf 418 KB, 21 pages)
• 3.2.3 Fluoroquinolones and Aortic Aneurysm or Dissection (pdf 1002 KB, 32 pages)
• 3.2.4 Sertraline and Nortriptyline - Potential Drug-Drug Interaction (pdf 961 KB, 17 pages)

177th meeting - 14 March 2019

• 2.1 CARM quarterly report (pdf 3593 KB, 45 pages)
• 3.2.1 Fingolimod and tumefactive lesions (pdf 1804 KB, 39 pages)
• 3.2.2 NSAIDs - an update on CVD risk (pdf 3839 KB, 68 pages)
• 3.2.3 Methadone use in breastfeeding (pdf 1431 KB, 35 pages)
• 3.2.4 Update on nitrofurantoin use in renal impairment (pdf 2682 KB, 40 pages)
• 3.2.5 Ergotamine containing products and pancreatitis (pdf 522 KB, 13 pages)

2018

176th meeting - 6 December 2018

• 3.2.1 Hydrochlorothiazide (HCTZ) and Non-Melanoma Skin Cancer (NMSC) (pdf 772 KB, 28 pages)
• 3.2.2 Viekira Pak/ Viekira Pak-RBV and psychiatric changes (pdf 1098 KB, 37 pages)
• 3.2.3 Dose reductions for Pradaxa (dabigatran etexilate): DVT/PE indications (pdf 1289 KB, 17 pages)
• 3.2.4 Fetal exposure to lithium during pregnancy (pdf 578 KB, 19 pages)

175th meeting - 13 September 2018

• 2.1 CARM Quarterly Report (pdf 2412 KB, 34 pages)
• 3.2.1 Brand Switches in New Zealand (pdf 1064 KB, 32 pages)
• 3.2.2 Granulocyte-Colony Stimulating Factors, Pulmonary Haemorrhage and Haemoptysis (pdf 754 KB, 17 pages)
• 3.2.3 Dabigatran, gout, gout aggravation or gout-like symptoms (pdf 738 KB, 14 pages)

174th meeting - 3 July 2018

• 3.1.1 Consideration of Esmya (ulipristal acetate) under section 36 of the Medicines Act 1981 (pdf 849 KB, 35 pages)
• 3.2.1 Bexsero (recombinant Meningococcal group B vaccine) RMP (pdf 559 KB, 32 pages)
• 3.2.2 Atypical antipsychotics and sleepwalkingsleep-related eating disorder (pdf 345 KB, 25 pages)
• 3.2.3 Potential interaction between nefopam and tramadol (pdf 520 KB, 11 pages)
• 3.2.4 Isotretinoin- review of (1) pregnancy prevention measures and (2) obsessive compulsive disorder (pdf 1115 KB, 54 pages)

173rd meeting - 8 March 2018

• 2.1 Centre for Adverse Reactions Monitoring (CARM) Quarterly Reports (pdf 3653 KB, 33 pages)
• 3.2.1 Levonorgestral emergency contraception and weight-based efficacy (pdf 1067 KB, 25 pages)
• 3.2.2 Codeine - safety concerns when used in children (pdf 942 KB, 37 pages)
• 3.2.3 Medroxyprogesterone and withdrawal syndrome (pdf 3653 KB, 13 pages)
• 3.2.4 NSAIDs and cardiovascular risk (pdf 621 KB, 20 pages)
• 3.2.5 Risk Management Plan for nusinersen (pdf 762 KB, 21 pages)
• 3.2.6 Ulipristal acetate and drug induced liver injury (pdf 492 KB, 19 pages)

2017

172nd meeting - 7 December 2017

• 3.2.1 Assessment of the potential risk of disabling and persistent musculoskeletal and nervous system adverse reactions from the use of fluoroquinolones (pdf 333 KB, 19 pages)
• 3.2.2 Modified-release paracetamol: risk of overdose (pdf 1180 KB, 33 pages)
• 3.2.3 Influvac Tetra – Risk Management Plan (pdf 386 KB, 26 pages)
• 3.2.4 Gabapentin and the risk of respiratory depression without concomitant opioids (pdf 746 KB, 21 pages)
• 3.2.5 Natalizumab (Tysabri) and haematological abnormalities in newborns whose mothers were treated with natalizumab during pregnancy (pdf 1348 KB, 38 pages)

171st meeting - 14 September 2017

• 3.2.1 Use of sodium valproate in pregrancy (pdf 3386 KB, 82 pages)
• 3.2.2 Review of immune checkpoint inhibitors in the New Zealand context  (pdf 1449 KB, 44 pages)
• 3.2.3 Risks of severe depression, anxiety and suicidal ideation with hormonal contraceptives (pdf 1087 KB, 45 pages)

170th meeting - 8 June 2017

• 3.2.1 Safety of antibiotic ear drops in children with grommets ((pdf 515 KB, 19 pages)
• 3.2.2 NSAIDs and spontaneous abortion (pdf 892 KB, 28 pages)
• 3.2.3 Risk of haemorrhage from concomitant use of statins and dabigatran (pdf 661 KB, 34 pages)
• 3.2.4 Gadolinium based contrast agents and accumulation in brain tissue (pdf 4768 KB, 100 pages)

MARC papers previously published under the OIA

168th meeting - 1 December 2016

• 3.2.2 Risk Communication (pdf 1.8 MB, 47 pages)

167th meeting - 8 September 2016

• 3.2.3 National immunisation schedule change to Gardasil 9 as a 2 dose schedule for boys and girls (pdf 4.2 MB, 54 pages)

163rd meeting - 10 September 2015

• 3.2.3 Gardasil and autoimmune diseases (pdf 2.4 MB, 46 pages)