MADRAC Bulletin

The MADRAC Bulletin is now a bi-monthly publication that provides a selection of local safety signals and articles discussing local individual case safety reports (ICSRs) meant to raise awareness among healthcare professionals. Information contained in this publication is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.

The MADRAC Bulletin also features pharmacovigilance-related activities conducted by the National Pharmaceutical Regulatory Agency (NPRA) and contains a list of directives based on safety issues advised by the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) and endorsed by the Drug Control Authority (DCA) as well as safety alerts that have been published on the NPRA website.

To receive the latest issues of MADRAC Bulletin, you may join the NPRA Safety Information Mailing List by filling out the subscription form at

The MADRAC Bulletin is intended for healthcare professionals and is only available in English.

MADRAC Bulletin Vol. 41 Issue 02/2023

Articles based on Case Report 

  • Tenofovir Disoproxil Fumarate-Induced Fanconi Syndrome in a Patient with Hepatitis B
  • Reminder on the Risk of Diplopia with High Dose and Prolonged Use of Carbamazepine

What's New?

  • List of Safety Alerts/Directives Related to Drug Safety Issues

MADRAC Bulletin Vol. 40 Issue 01/2023


  • Venturing into Quantitative Signal Detection


  • Cephalosporins – Severe Cutaneous Adverse Reactions (SCARs)
    • Cefazolin – Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
    • Cefepime – Acute Generalised Exanthematous Pustulosis (AGEP)


  • Adverse Event Reports Received 2013-2022

What's New?

  • List of Safety Alerts/Directives Related to Drug Safety Issues

MADRAC Bulletin - 03/2022 Edition


▪ Pharmacovigilance Seminar: Pharmacovigilance for Safer Use of Medicines

Articles based on Case Report 

▪ Risk of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) following Vaxzevria Vaccination
▪ Sacubitril/Valsartan: Risk of Psychiatric Events

What's New?
▪ List of Directives Related to Drug Safety Issues

MADRAC Bulletin - 02/2022 Edition


▪ Malaysian NPRA-Australian TGA Seminar on Safety Signal Management
▪ NPRA’s Training Workshops on COVID-19 Vaccine AEFI Reporting, Case Investigation and Risk Communication
▪ Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #4

Articles based on Case Report 

▪ Iron Dextran: Risk of Seizures
▪ Hydroxyurea for Myeloproliferative Disorder: Risk of Cutaneous Vasculitis and Gangrene
▪ Venetoclax-Induced Tumour Lysis Syndrome
▪ Atypical Antipsychotics: Risk of Urinary Retention 

What's New?
▪ List of Directives Related to Drug Safety Issues

MADRAC Bulletin - 01/2022 Edition


▪ Adverse Event Reports for 2011-2021
▪ Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #2
▪ Welcome MADRAC 2022-2024
▪ COVID-19 Vaccine Special Pharmacovigilance Committee (JFK)

Articles based on Case Report 

▪ Myocarditis in Adolescents Following COVID-19 Vaccination
▪ Ciprofloxacin-Induced Thrombocytopenia
▪ Cyclopentolate Eye Drops in Children: Risk of Psychotic Reaction
▪ Neonatal Gynaecomastia and Galactorrhoea with Prolonged Use of Morphine

MADRAC Bulletin - 03/2021 Edition


▪ Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia
▪ Thank You MADRAC 2019-2021

Articles based on Case Report 

▪ Risperidone: Risk of Hyperprolactinaemia
▪ Efavirenz-Induced Gynaecomastia

▪ Ceftriaxone: Reminder on the Risk of Encephalopathy

What's New?
▪ List of Directives Related to Drug Safety Issues

MADRAC Bulletin - 02/2021 Edition

Articles based on Case Reports

▪ Clozapine-induced gastrointestinal hypomotility (CIGH)

▪ Dapsone-induced methaemoglobinaemia

▪ Gastrointestinal adverse effects associated with immune checkpoint inhibitors

▪ Ophthalmic preparations of vascular endothelial growth factor (VEGF) inhibitors: Risk of myocardial infarction

What’s New

▪ List of directives related to drug safety issues


MADRAC Bulletin - 01/2021 Edition


▪ Adverse event reports for 2010-2020
▪ NPRA updates on reports of kidney-related and liver-related adverse reactions after consumption of ganoderma (lingzhi / reishi) products

Articles based on Case Report 

▪ Chlorpheniramine: A very rare incidence of dystonia
▪ Is there a risk of erectile dysfunction associated with the use of atorvastatin?
▪ Phenytoin: Risk of atrioventricular (AV) block

▪ Azithromycin: A reminder of the risk of cardiac death

What's New?
▪ List of directives related to drug safety issues

MADRAC Bulletin - 03/2020 Edition

Articles based on Case Report 

▪ Shoulder injury related to vaccine administration (SIRVA): A preventable occurrence

▪ Jarisch-Herxheimer reaction: An adverse drug reaction following treatment with benzathine   penicillin in syphilis patients

▪ Rapid correction of hyponatraemia with intravenous saline solution causing osmotic   demyelination syndrome

▪ Sulfamethoxazole-trimethoprim-induced drug reaction with eosinophilia and systemic   symptoms (DRESS)


MADRAC Bulletin - 02/2020 Edition


▪ Preliminary report: Local adverse drug reactions associated with drugs used for COVID-19 infections 

Articles based on Case Report 

▪ Hydrochlorothiazide: Risk of hearing disorder
▪ Amlodipine and peripheral neuropathy

▪ Ceftazidime: Risk of acute generalised exanthematous pustulosis (AGEP)

What's New?
▪ List of Directives Related to Drug Safety Issues (May - August 2020)

MADRAC Bulletin - 01/2020 Edition

▪ Adverse Event Reports for 2019

Articles based on Case Report 
▪ Aminophylline overdose: Risk of urinary retention
▪ Levothyroxine: Risk of myocardial infarction
▪ Rare case of hypotonic-hyporesponsive episode following pentavalent vaccine immunisation

What's New?
▪ List of Directives Related to Drug Safety Issues (January - April 2020)

MADRAC Bulletin - 03/2019 Edition

Articles based on Case Report 
▪ Erythropoiesis-stimulating agents: A reminder on the cardiovascular risk in patients with chronic kidney disease
▪ Amiodarone: Risk of acute hepatitis

▪ Levothyroxine: Reminder on the risk of restlessness or irritability

▪ Immunisation anxiety-related reactions

What's New?
▪ List of Directives Related to Drug Safety Issues (September - December 2019)

MADRAC Bulletin - 02/2019 Edition

▪ NPRA's ADR Workshop for Pharmacists

Articles based on Case Report 
▪ Zidovudine: Higher Occurrence in Malaysia?
▪ Colchicine: Reminder on the Risk of Rhabdomyolysis
▪ Pembrolizumab: Reminder on the Risk of Pneumonitis

What's New?
▪ List of Directives Related to Drug Safety Issues (May - August 2019)

MADRAC Bulletin - 01/2019 Edition

▪ Adverse Event Reports for 2018

Articles based on Case Report 
▪ Ophthalmic preparations containing dexamethasone: Risk of Worsening Corneal Ulceration
▪ Heparin-induced Thrombocytopenia

What's New?
▪ List of Directives Related to Drug Safety Issues (January - April 2019)

MADRAC Bulletin - 03/2018 Edition

▪ Thank You MADRAC 2016-2018

Articles based on Case Report 
▪ Amlodipine: Reminder on the Risk of Increase in Urinary Frequency and Nocturia
▪ SGLT-2 Inhibitors: Local Reports of Euglycaemic Diabetic Ketoacidosis
▪ Atezolizumab: Reminder on the Risk of Hyperthyroidism 

What's New?
▪ List of Directives Related to Drug Safety Issues (September - December 2018)

MADRAC Bulletin - 02/2018 Edition

▪ Adverse Reaction Report for Year 2017

Articles based on Case Report 
▪ Psychiatric Events Following Administration of Amoxicillin/Clavulanate
▪ Colour Vision Change Following Use of Tranexamic Acid
▪ Risk of Hypoglycaemia with Systemic Use of Fluoroquinolones

What's New?
▪ List of Directives Related to Drug Safety Issues (May - August 2018)

MADRAC Bulletin - 01/2018 Edition

▪ Recent Safety Issues with Fluoroquinolones

Articles based on Case Report
▪ Simvastatin: Reminder on the Risk of Cognitive Impairment
▪ Dipeptidyl Peptidase-4 Inhibitors: Reminder on the Risk of Pancreatitis
▪ Povidone-iodine Gargle: Risk of Hypothyroidism
▪ Adulteration of Traditional Products with Corticosteroids: Risk of Psychiatric Disorders

What's New?
▪ List of Directives Related to Drug Safety Issues (January - April 2018)



MADRAC Bulletin - 03/2017 Edition

Safety Issues Presented to MADRAC in 2017

Regulatory Matters
▪ Fluconazole: Risk of Spontaneous Abortion and Multiple Congenital Abnormalities
▪ Tramadol: Restricted Use in Children and Warnings of Use in Pregnant and Breastfeeding Women
▪ Metformin: Use in Patients with Moderately Reduced Kidney Function
▪ Metronidazole: Risk of Hepatotoxicity in Patients with Cockayne Syndrome
▪ Aripiprazole: Risk of Pathological Gambling and Impulse-Control Problems

ADR Reporting
▪ CPD Points for Quality ADR Reporting 


MADRAC Bulletin - 02/2017 Edition

Regulatory Matters
▪ Chlorhexidine preparations: Risk of hypersensitivity reactions
▪ Miconazole & Warfarin: Risk of severe bleeding as a result of drug interaction
▪ Inhaled Corticosteroids: Increased risk of pneumonia in Chronic Obstructive Pulmonary Disease (COPD) patients
▪ Etoricoxib: New dosing for rheumatoid arthritis and ankylosing spondylitis

What’s New
▪ Annie & Mac’s Adventures: Pharmacovigilance Comic Book Pilot Survey
▪ Pharmacovigilance Inspection Training at the UK MHRA


MADRAC Bulletin - 01/2017 Edition

▪ Cyclopentolate Eye Drops Use in Premature Infants: Risk of Respiratory Adverse
▪ Colchicine: Reminder on the Risk of Toxicity
▪ Summary of Safety Concerns Linked to Dipeptidyl Peptidase (DPP)-4 Inhibitors

Regulatory Matters
▪ Levonorgestrel-containing Emergency Hormonal Contraception: New Advice on
Interactions with Hepatic Enzyme Inducers and Contraception Efficacy

What’s New?
▪ Reaching Out to the Public


MADRAC Bulletin - Disember 2016 Edition

Regulatory Matters
▪ Olanzapine: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
▪ Codeine: Risk of respiratory depression
▪ Warfarin: Rare cases of calciphylaxis
▪ Advice on the risk of lower limb amputation during treatment with Invokana®(canagliflozin)
▪ List of Direct Healthcare Professional Communication (DHPC) letters for 2016

What’s New?
▪ Malaysian Pharmacovigilance Guidelines (2nd Edition)
▪ Vaccine Pharmacovigilance Guidelines (2nd Edition)
▪ Preparing for Pharmacovigilance Inspection


MADRAC Bulletin- Ogos 2016 Edition

Annual Report for 2015
   ▪ Spontaneous Adverse Drug Reactions (ADRs) including Adverse Events Following Immunisation (AEFIs) Reported in Malaysia
Regulatory Matters
   ▪ Bisphosphonates: Risk of osteonecrosis of the external auditory canal.
   ▪ Minyak Cajeput (Melaleuca leucodendran): Risk of glottal spasm and bronchospasm.
   ▪ Glivec (imatinib) and Tasigna (nilotinib): Risk of Hepatitis B Virus reactivation.
   ▪ Adempas (riociguat): New contraindication for patients with pulmonary hypertension associated with idiopathic interstitial

What’s New?
▪ Consumer Side Effect Reporting Form (ConSERF)


MADRAC Bulletin - April 2016 Edition

  • Welcoming the new MADRAC members (2016-2018)
  • Pharmacogenomics in Determining Drug Response
  • Azithromycin: Risk of QT Prolongation and DRESS
  • Mycophenolate: Important New Information on the Teratogenic Risk
  • Prolia® and Xgeva® (denosumab): Clinically Significant Cases of Hypercalcaemia after Cessation of Treatment with Denosumab in Paediatric Patients
  • Viekirax® and Exviera®: Not Recommended in Patients with Moderate Hepatic Impairment (Child-Pugh B)
  • Xalkori® (crizotinib): Inclusion of a New Warning Regarding Cardiac Failure
  • Pharmacists: CPD Points for Quality ADR Reports


MADRAC Bulletin - Disember 2015 Edition

  • Succinylated Gelatin Intravenous Infusion Products - Summary of Safety Review in 2015
  • Amlodipine: Possible Risk of Blurred Vision
  • Cardiovascular Adverse Events Related to Diclofenac
  • Direct Healthcare Professional Communications (DHPCs) Reviewed and Approved by NPCB in 2015
  • Montelukast: Risk of Thrombocytopenia
  • Dipeptidyl Peptidase-4 (DPP-4) Inhibitors: Risk of Severe Joint Pain
  • Fusafungine: Risk of Serious Allergic Reactions
  • New and Improved ADR Reporting Form (Blue Form)
  • ADR Reports Involving Anti-Tuberculosis Drugs


MADRAC Bulletin - Ogos 2015 Edition

  • New Restrictions of Use for Metoclopramide and Domperidone
  • Rotavirus Vaccine: Risk of Intussusception
  • Drug Safety Issues Discussed in 2014
  • Early Detection of Serious Skin Reactions: Auxiliary Warning Label
  • Paracetamol: Risk of Serious Skin Reactions
  • Does Your Patient Need MedicAlert®?.......Do You?

MADRAC Bulletin - April 2015 Edition

  • Annual Report for 2014:
    • Spontaneous ADRs Reported in Malaysia
    • Drug Safety Issues Discussed in 2014
  • Prolia and Xgeva (denosumab): Minimising the Risk of Severe Symptomatic Hypocalcaemia (SSH) and Osteonecrosis of the Jaw (ONJ)

  • Guide for ADR Reporters: VigiAccess by the WHO

MADRAC Bulletin 2014 - Disember Edition

- Macrolides: Overview of Local ADR Data and Updates on the Risk of QT Interval Prolongation
- The Association of Human Leukocyte Antigens and Drug Hypersensitivity Syndrome
- Topiramate: Association with Visual Field Defects
- Artrodar® (diacerein): Risk of Severe Diarrhoea and Hepatotoxicity
- List of Direct Healthcare Professional Communications (DHPCs) for 2014
- Guide for ADR Reporters: Cosmetics May Cause Adverse Reactions Too - Please Report

MADRAC Bulletin 2014 - Ogos Edition

- Annual Report for 2013:
· Spontaneous ADRs Reported in Malaysia
· Drug Safety Issues Discussed in 2013
- Statins: Important Safety Labelling Changes
- Local ADR Case Reports:
· Tinnitus Following Use of Metformin
· Implanon NXT® (etonogestrel): Drug Interaction with Antituberculosis Medication
- Update on Protaxos (strontium ranelate): Black Box Warning to Minimise Cardiovascular Risk
- Guide for ADR Reporters: A Focus on Quality- What is the WHO Completeness Score?

MADRAC Bulletin 2014-April Edition

- Individual Genetic Make-up, A Key to Personalised Medicine 
- Human Papillomavirus (HPV) Vaccine: Complex Regional Pain Syndrome (CRPS)
- Allopurinol: Impact of Risk Minimisation Actions
- Oral Ketoconazole: Restriction of use to hospitals and tightening of indications 
- Synthetic Calcitonin Salmon: Restriction of indications and duration of use
- Intravenous Ondansetron: Dose-dependent QT interval prolongation
- Erbitux® (cetuximab) and Vectibix® (panitumumab): The importance of establishing wild-type RAS status (exons 2,3, and 4 of KRAS and NRAS) before treatment
- Cyproterone Acetate 2mg and Ethinylestradiol 0.035mg: Minimising the risk of thromboembolism
- Safety Alerts for Healthcare Professionals

MADRAC ADR 2013-Disember

- Hydroxyethyl Starch (HES)-containing Products: New Safety Updates due to Recent Published Data on Increased Mortality and Risk of Kidney Injury Requiring Dialysis
- Acetylcysteine: New Regimen with Reduced Adverse Effects?
- Guide for ADR Reporters: Improving Quality of Reports / Laboratory Testing for Suspected Adulterated Products
- Protaxos® (strontium ranelate): Increased Risk of Serious Heart Problems
- Xeloda® (capecitabine): Association with Severe Skin Reactions such as Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
- Jevtana® (cabazitaxel): Potential for Medication Error During Preparation
- Abstract: Predictors of Serious Adverse Drug Reactions in Association with Complementary and Alternative Medicine in Malaysia

MADRAC ADR 2013-Ogos

- Carbimazole vs. propylthiouracil (PTU): A comparison of drug safety profiles based on spontaneous ADR reports in Malaysia
- Promethazine- Use in children aged less than two years
- Annual report for 2012- Suspected ADRs Reported in 2012: An overview
- Votrient (pazopanib hydrochloride)- Change in frequency of serum liver test monitoring for hepatotoxicity
- Mabthera (rituximab)- New risk management of hepatitis B reactivation in patients prior to initiation of therapy
- Avastin (bevacizumab)- Association with necrotizing fasciitis
- Guide for ADR reporters: Improving quality of reports

MADRAC ADR 2013- April

- Welcoming the MADRAC Committee for 2013-2015
- A Spotlight on Traditional Medicines
- Trimetazidine: New recommendations on the restriction of use
- Local ADR case reports: Benzyl benzoate/ pine tar; Medroxyprogesterone
- Other activities by the Pharmacovigilance Section

MADRAC ADR 2012- Disember

Special 25th Anniversary Edition
- Adverse Drug Reactions and Pharmacovigilance
- Achievements over the last 25 years
- The way forward

MADRAC ADR 2012 - Ogos

- sAllopurinol: Update on the usage in MoH facilities and related adverse cutaneous drug reactions
- Cipram (citalopram): Abnormal heart rhythms associated with doses more than 40mg per day
- Varicella vaccines: A review on breakthrough varicella infection


MADRAC ADR 2012 - April

- Activities of MADRAC in 2011
- Strontium Ranelate: New contraindications in venous thromembolic events (VTE) and revised warnings on severe skin reactions
- Rasilez (aliskiren): Concomitant use with ACE-inhibitor and ARBs in patients with Type 2 Diabetes Mellitus is contraindicated

MADRAC ADR 2011 - Disember

- Erythropoiesis-stimulating agents (ESA) in chronic kidney disease: Modified dosing recommendations
- Multaq (dronedarone): Increased risk of serious cardiovascular events in permanent AF patients
- Aclasta (zoledronic acid): Contraindication in severe renal impairment
- Pradaxa (dabigatran etexilate): Safety updates on risk of fatal bleeding
- Biphosphonates: Risk of atypical fractures of the thigh

MADRAC ADR 2011 - Ogos 
- 5-Alpha reductase inhibitors (5-ARIs): Increased risk of high grade prostate cancer
- Beta-agonists: Strengthened warnings against use in preterm labour
- Fluoroquinolones: Exacerbation of Myasthenia gravis
- Antipsychotic drugs: Class labeling updates on use during pregnancy and potential risk to newborns
- Benzocaine topical products: Risk of methaemoglobinaemia 
- Cervarix: Overview of the National Immunization Programme

MADRAC ADR 2011 - April 

- Activities of MADRAC in 2010
- Multaq (dronedarone): Drug-induced hepatotoxicity
- Ketoprofen-containing topical medicinal products: Risk of photoallergy reactions
- Clinical manifestations of cutaneous adverse drug reactions

 MADRAC ADR 2010 - Disember 

- Avandia (Rosiglitazone)& Combination Products: Restriction of Use Due to Cardiovascular Risk
- Sibutramine: Cancellation of Registration Due to Safety Concern
- Lamictal (Lamotrigine): Risk of Aseptic Meningitis
- Tygacil (Tigecycline): Increased Mortality Risk
- Allopurinol-induced Adverse Cutaneous Drug Reactions
- Malaysian ADR Forms: Best Among 10 Countries
- New Reporting Form for Adverse Events Following Immunisation (AEFI)
- How Can We Serve You Better?

MADRAC ADR 2010 - Ogos 

- Mucolytic Agents: Contraindication in Children Below 2 Years of Age
- Arava (Leflunomide): Boxed Warning- Risk of Severe Liver Injury
- Promacta (Eltrombopag): Portal Venous System Thomboses in Study of Patients with Chronic Liver 
- Prometazine Hydrochloride Injection: Updated Information on Respiratory Depression and Severe 
Tissue Injury
- Propylthiouracil: New Boxed Warning on Severe Liver Injury
- Proton-Pump Inhibitors (PPI): Possible Increased Risk of Fractures
- Carbapenems: Summary Report
- H1N1 Vaccines – Update
- Ultram & Ultracet: Risk of Suicide and Overdosage
- Liquid Vitamin D Supplement Products: Risk of Overdosage in Infants

MADRAC ADR 2010 - April 

- ADR Reporting for 2009: An Overview
- Summary of MADRAC Recommendations for Regulatory Actions: Year 2009
- Sibutramine: A Safety Concern
- Cardiamed: Suspension of Marketing Authorisation Lifted
- Rotarix Vaccine: Presence of DNA Fragments from PCV-1
- Avandia: The Current Safety Status
- Invirase: Cardiovascular Risk with Concurrent Use of Norvir
- WHO Recommendations on Antiretroviral Therapy
- Allopurinol: Prescribing for the Right Indications
- Amlodipine: Incidence of Coughing

 Newsletter: MADRAC Bulletin / Archive


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