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2021
- Sacubitril/valsartan: Risk of psychiatric events 2021-09-09
- Oseltamivir: Risk of haemorrhages 2021-07-08
- Antidepressants (citalopram; desvenlafaxine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine; vortioxetine): Risk of Postpartum Haemorrhage (PPH) 2021-04-22
- Tecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) 2021-04-22
- Vascular endothelial growth factor (VEGF) inhibitors for systemic use (except application on eyes): Risk of artery dissections and aneurysms 2021-04-20
- Mirtazapine: Risks of (i) Amnesia and (ii) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) 2021-04-20
- Ceftriaxone: Risk of encephalopathy 2021-04-20
- Safety Updates on COVID-19 Vaccine (Comirnaty®) 2021-02-17
- Mesalazine and sulfasalazine: Nephrolithiasis 2021-01-29
- Efavirenz (including combination products): Risk of late onset neurotoxicity 2021-01-29
- Oseltamivir: Thrombocytopenia 2021-01-29
- Clozapine: Risk of serious bowel complications caused by constipation 2021-01-29
- Abiraterone: Risk of hypoglycaemia due to drug interaction 2021-01-29
- Ondansetron: Information updates on risk of birth defects 2021-01-20
- Alemtuzumab (Lemtrada®): Revised indication, additional contraindications and risk minimisation measures 2021-01-20
- Tumour Necrosis Factor alpha (TNFα): Kaposi’s Sarcoma 2021-01-20
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2020
- Esmya (ulipristal acetate 5 mg): Withdrawal of product registration 2020-12-14
- Gilenya® (fingolimod): New contraindication in pregnant women and in women of childbearing potential who are not using effective contraception 2020-09-08
- Parenteral nutrition containing amino acids and/or lipids: Risk of toxic degradations of ingredients when exposed to light, which may lead to adverse outcomes in paediatric patients less than 2 years of age 2020-08-27
- Propofol: Risk of priapism 2020-08-25
- Plaquenil® (hydroxycholoroquine): Risk of QT prolongation and other drug-drug interactions in the context of COVID-19 management 2020-08-14
- Topiramate: Risk of uveitis 2020-08-06
- Insulin: Risk of cutaneous amyloidosis 2020-08-06
- Reminder on the risk of oculogyric crisis with metoclopramide use 2020-06-24
- Domperidone: Restriction of use in paediatric patients less than 12 years of age 2020-06-04
- Proton pump inhibitors: Risk of microscopic colitis 2020-05-28
- Gabapentin: Risk of dysphagia 2020-05-28
- Rocuronium: Kounis syndrome 2020-05-12
- Nintedanib: Ischaemic colitis 2020-05-12
- Guselkumab: Risk of anaphylaxis 2020-04-07
- Esmya (ulipristal acetate 5 mg): Product recall due to potential risk of liver injury 2020-04-06
- Intravenous iron-containing products: Kounis syndrome 2020-04-06
- Nivolumab: Reports of cytomegalovirus (CMV) infection or reactivation 2020-04-06
- Kyprolis® (carfilzomib): (i) Risk of progressive multifocal leukoencephalopathy (PML); (ii) Risk of hepatitis B virus (HBV) reactivation 2020-04-06
- Esbriet® (pirfenidone): Drug-induced liver injury (DILI) 2020-04-06
- MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:3/3/2020] 2020-03-03
- Sulfasalazine: Interference with dihydronicotinamide-adenine dinucleotide/ dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADPH) reaction assays 2020-02-26
- Ondansetron: Birth defects 2020-02-26
- Cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors: Risk of severe lung inflammation 2020-02-26
- MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:05/12/2019] 2020-02-11
- New safety measure for sodium valproate: (i) Risk of congenital malformation in neonates and neurodevelopmental problems in children exposed to sodium valproate during pregnancy; (ii) Additional educational material for healthcare professionals and patients/caretakers 2020-01-21
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2019
- Retinoids: Updated measures for pregnancy prevention during retinoids use 2019-11-26
- FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study 2019-11-26
- Soalan-soalan Lazim (FAQ): Impuriti NDMA di dalam Produk Ranitidine 2019-11-26
- Smecta® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women 2019-10-30
- Clopidogrel: Interaction with boosted antiviral Human Immunodeficiency Virus (HIV) therapy leading to insufficient inhibition of platelet aggregation 2019-09-03
- LEMTRADA® (alemtuzumab): (i) Risk of autoimmune hepatitis (ii) Other serious reactions temporally associated with alemtuzumab infusion (iii) Haemophagocytic lymphohistiocytosis 2019-09-03
- Diclofenac (systemic use): (i) Risk of anastomotic leakage and (ii) Risk of Kounis syndrome 2019-08-26
- Actemra® (tocilizumab): New important identified risk of hepatotoxicity 2019-08-26
- Imovane® (zopiclone): New restriction of the indication and additional warnings on abuse and dependence 2019-06-20
- TECENTRIQ® (atezolizumab): A new important identified risk – immune-related myositis 2019-06-20
- Posaconazole: Pseudohyperaldosteronism 2019-06-20
- Deferiprone: Risk of neurological disorders in children 2019-06-12
- DARZALEX (daratumumab): New identified risk of Hepatitis B Virus reactivation 2019-06-12
- Benlysta® (belimumab): Increased risk of serious psychiatric events 2019-06-12
- MADRAC Bulletin - 01/2019 Edition 2019-05-29
- Kenyataan Akhbar KPK 29 Mac 2019 -Produk Losartan yang ditarik Balik di Singapura Serta Situasi di Pasaran Malaysia 2019-04-12
- Kenyataan Akhbar KPK 5 April 2019 – Panggil Balik ke atas Produk Tradisional Mengandungi Paras Logam Berat yang Tinggi 2019-04-09
- Carbimazole and methimazole (thiamazole): (i) Risk of birth defects and neonatal disorders in case of exposure during pregnancy; (ii) Risk of pancreatitis 2019-04-09
- Oral retinoids: Risk of neuropsychiatric symptoms 2019-04-04
- Tapentadol: Risk of seizures and reports of serotonin syndrome when co-administered with other drugs 2019-04-04
- Kenyataan Akhbar KPK 18 Mac 2019 – Produk Tradisional Nan Bao Capsule Dikesan Mengandungi Racun Berjadual Sildenafil Dan Tadalafil 2019-03-18
- Xylometazoline: Increased risk of serious ventricular arrhythmia in patients with long QT syndrome 2019-03-15
- Direct-Acting Antivirals (DAAVs) : Risk of hypoglycaemia in patients with diabetes 2019-03-15
- Lamotrigine: Risk of hemophagocytic lymphohistiocytosis (HLH) 2019-01-31
- Ceftriaxone: Disturbed consciousness, convulsions or involuntary movements 2019-01-31
- Beta-Lactam antibiotics: Severe Cutaneous Adverse Reactions (SCARs) 2019-01-31
- Acetazolamide: A new contraindication during pregnancy 2019-01-31
- Epilim® (Sodium Valproate): Important new restrictions on use 2019-01-31
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2018
- New Publication: MADRAC Bulletin - Issue 2/2018 2018-12-24
- Fluoroquinolones: Risk of aortic aneurysm and dissection 2018-12-19
- Direktif untuk semua produk yang mengandungi pemetrexed: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan nephrogenic diabetes insipidus dan renal tubular 2018-12-10
- Direktif untuk semua produk yang mengandungi filgrastim, pegfilgrastim dan lenograstim: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan aortitis. 2018-12-10
- Direktif untuk semua produk yang mengandungi domperidone: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat berkaitan interaksi ubat yang mengakibatkan peningkatan risiko QT interval prolongation. 2018-12-10
- Produk Valsartan Dan Losartan Yang Ditarik Balik Di Amerika Syarikat Serta Situasi Di Pasaran Malaysia 2018-11-23
- Succinylated gelatin (modified fluid gelatin): Possible cross-reactions involving the allergen galactose-alpha-1,3-galactose (Alpha-gal) 2018-10-26
- Tivicay® (dolutegravir): Reports of neural tube defects 2018-10-26
- Xgeva® (denosumab): Risk of new primary malignancy 2018-10-26
- Eltrombopag: Risk of interference with bilirubin and creatinine test results 2018-10-26
- Tecentriq® (atezolizumab): Risk of nephritis 2018-10-26
- Esmya® (ulipristal acetate): New contraindication, restricted indication and liver function monitoring requirement 2018-10-26
- MADRAC Bulletin - Issue 02/2018 2018-10-15
- Direktif Untuk Semua Produk Yang Mengandungi Iodinated Contrast Media: Pengemaskinian Sisip Bungkusan Dengan Maklumat Keselamatan Berkaitan Severe Cutaneous Adverse Reactions (SCARs) 2018-07-26
- Direktif Untuk Semua Produk Yang Mengandungi Azithromycin, Clarithromycin, Erythromycin Dan Roxithromycin: Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Maklumat Keselamatan Berkaitan Severe Cutaneous Adverse React 2018-07-26
- Direktif Untuk Semua Produk Yang Mengandungi Doxycycline: Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Maklumat Keselamatan Berkaitan Jarisch-Herxheimer Reaction 2018-06-27
- Direktif Untuk Semua Produk Yang Mengandungi Prednisone Dan Prednisolone (Kecuali Persediaan Topikal): Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Maklumat Keselamatan Berkaitan Scleroderma Renal Crisis 2018-06-27
- Direktif Untuk Semua Produk Yang Mengandungi Efavirenz: Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Maklumat Keselamatan Berkaitan Qtc Prolongation 2018-06-27
- Direktif Untuk Semua Produk Yang Mengandungi Acetazolamide: Pengemaskinian Sisip Bungkusan Dan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) Dengan Maklumat Keselamatan Berkaitan Severe Cutaneous Adverse Reactions (SCARs) 2018-06-27
- Acetazolamide: Risk of Severe Cutaneous Adverse Reactions (SCARs) 2018-06-25
- Drug interaction of oral contraceptives containing ethinylestradiol with the direct-acting antiviral combinations of paritaprevir, ritonavir and ombitasvir with or without dasabuvir 2018-06-16
- Esmya® 5 mg tablets (ulipristal acetate): Women taking Esmya® for uterine fibroids to have regular liver tests while safety review is ongoing; do not initiate treatment in new patients or those who have completed a previous treatment course 2018-04-24
- Direktif untuk semua produk yang mengandungi mesalazine: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan amaran kesan advers photosensitivity. 2018-04-18
- Doxycycline: Risk of Jarisch-Herxheimer reaction 2018-03-23
- Gadolinium-based Contrast Agents: Suspension/restriction of use following evidence of gadolinium deposits in the brain after magnetic resonance imaging (MRI) body scans 2018-03-23
- Intravenous (IV) fluids containing electrolytes and/or carbohydrates: Risk of hyponatraemia 2018-03-23
- Levetiracetam and methotrexate: Risk of drug-drug interaction 2018-03-23
- Direktif untuk semua produk yang mengandungi amoxicillin termasuk kombinasi: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan memperkukuhkan maklumat berkaitan Severe Cutaneous Adverse Reactions (SCARs) pada bahagian Side Effect 2018-02-28
- Direktif penambahan kenyataan amaran bagi semua produk yang mengandungi Boswellia spp 2018-02-27
- Direktif untuk semua produk yang mengandungi gabapentin: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan maklumat keselamatan berkaitan Respiratory Depression 2018-02-27
- Ofev® (nintedanib): Information on severe liver injury and the need for regular monitoring of liver function associated with the use in patients with idiopathic pulmonary fibrosis (IPF) 2018-02-22
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2014
