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

Features
▪ Cyclopentolate Eye Drops Use in Premature Infants: Risk of Respiratory Adverse
Events
▪ 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
pneumonia.

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 
Disease
- 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