Newsletter: MADRAC Bulletin / Archives

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MADRAC Newsletter 2009 - December 

- Potential Medication Errors with Tamiflu for Oral Suspension
- Update on Oseltamivir ADRs
- Early Communication about an Ongoing Review of Orlistat (Marketed as Alli and Xenical)
- Update on Pandemrix H1N1 Vaccine
- Immunosuppressants and Increased Risk for Opportunistic Infections Such As Activation of Latent Viral Infections Including BK Virus-Associated Nephropathy
- Severe Drug Interaction Between Colchicine and P-Glycoprotein or Strong CYP3A4 Inhibitors
- Alendronates and Atypical Stress Fractures
- Hydroxycut- Withdrawal of Suspension
- Potential Risk Associated With Concomitant Use of Ceftriaxone With Calcium-containing Intravenous Solutions
- Local Case Report: Gardasil- Drug Exposure During Pregnancy

 Click to Download  0.82 MB

MADRAC ADR Newsletter 2009 - August 

- Cutaneous Adverse Drug Reactions: An Overview of Local ADR Reports in 2008
- Cellcept (Mycophenolate Mofetil) and Pure Red Cell Aplasia (PRCA)
- Rapamune- Increase in Mortality in Stable Liver Transplant Patients
- Cefepime: Update of Ongoing Safety Review
- Early Communication about Safety of Lantus (insulin glargine)
- Secondary Exposure to Androgel
- Propylthiouracil (PTU)-induced Liver Failure
- Possible Interaction between Clopidogrel and Proton Pump Inhibitors
- Drug Exposure during Pregnancy- Gardasil
- Diphteria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus Influenza Type B Conjugate Vaccine (Pentaxim)

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 MADRAC ADR Newsletter 2009-May 

- Adverse Drug Reaction Reports for 2008- An Overview
- Ten Drugs with the Most Reported Adverse Drug Reactions
- Ten Best Reporting Hospitals
- Summary of Regulatory Actions Taken in 2008
- Oral Sodium Phosphate Products for Bowel Cleansing
- Association of Progressive Multifocal Leukoencephalopathy with Efalizumab
- Local Case Report: Goji Guarana
- Local Case Report: Tadalafil and Smell Loss

Click to Download  1.15 MB 

MADRAC ADR Newsletters 2008 - December 

- Champix (Varenicline): An Update
- Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Associated with the Use of Allopurinol
- Adverse Events Following Immunisation (AEFI)
- Acomplia (Rimonabant)
- Fluoroquinolones and Tendon Disorders
- Mentalk Candy

Click to Download  4.42 MB

MADRAC ADR Newsletter 2008 - August 

- Safety Issues:
- Champix (Varenicline)
- Mycophenolate Mofetil (Cellcept) and Mycophenolic Acid (Myfortic)- Risk in Pregnancy
- Cefepime – Reports of Death
- Mycophenolate Mofetil (Cellcept) and Mycophenolic Acid (Myfortic) and the Development of Progressive Multifocal Leukoencephalopathy
- Use of Cough and Cold Products in Children Under Two Years Old- An Update
- Exubera (Recombinant Human Insulin) and Primary Lung Malignancy
- Incidence of Myocardial Infarction in Pregnant Women Receiving Beta Agonist to delay Premature Labour- Additional Warning and Precaution
- Low Molecular Weight Heparin- Clexane Prefilled Syringes (Enoxaparin)
- Cardiamed- An Update
- Local Case Reports:
• Drug Exposure during Pregnancy- Olanzapine
• Kisan Injection 10mg/ml
• A Reminder: Metoclopramide- Usage in Children

Click to Download  1.15 MB

MADRAC ADR Newsletter 2008 - May 

- Adverse Drug Reactions (ADR) Reports for 2007 – An Overview
- Ten Drugs with the Most Reported Adverse Drug Reactions (Year 2002 – 2007)
- Ten Best Reporting Hospitals
- Summary of Regulatory Actions Taken in 2007
- Issues of Current Interest
• Severe Hyponatraemia and Seizures Associated with the Use of Desmopressin
• Botulinum Toxin
- Local Case Reports
• Tonik Warisan Banjar
• Cardiamed® (Noradrenaline) Injection

 Click to Download 1.19 MB

MADRAC ADR Newsletter 2007 - September

- Ten Drugs with the Most Reported Adverse Drug Reactions (Year 2000-2006)
- Metoclopramide: Tightened Use in Paediatrics
- Antipsychotics: Reports of Neuroleptic Malignant Syndrome
- Oseltamivir: Monitor for Signs of Unusual Behaviour
- Rosiglitazone and Rosiglitazone-containing Products Update
- Gadolinium-based Contrast Agents and Nephrogenic Systemic Fibrosis
- Sedative- Hypnotic Drug Products: Anaphylaxis Reactions and Complex Sleep-related Behaviours
- Restricted Use for Systemic Piroxicam
- Local Case Report: Sticopus Horrens (Gamat Extract): Renal Failure/ Nephrotic Syndrome

Click to Download 3.10 MB

MADRAC ADR Newsletter 2007 - December

- Trasylol® (Aprotinin) – Marketing Suspension
- Appropriate Use of Cough And Cold Products
- Avandia® (Rosiglitazone) – Update
- Byetta® (Exenatide) – Acute Pancreatitis
- Haloperidol – New Warning and Revised Prescription Information
- Ban on Red 2G Colouring Agent
- Deregistration of Nimesulide
- Local Case Reports
• Pediacel®
• Drug Exposure During Pregnancy - Sodium Valproate

Click to Download 0.55 MB

MADRAC ADR Newsletter 2007 - May

- Overview of ADR Reporting in Malaysia for the Year 2006
- Summary of Regulatory Action Taken in 2006
- Issues of Current Interest:
• Arcoxia (Etoricoxib)
• Interaction between Tramadol and Warfarin
• Pioglitazone Hydrochloride and Risk of Bone Fracture
• Nimesulide and Hepatic Failure
• Trasylol Labelling and Risk of Renal Dysfunction
• NSAIDs- Cardiovascular, Gastrointestinal and Cutaneous Safety Review
- Reports from Journal: In-utero Case Report
- Tegaserod Maleate and Risk of Cardiovascular Adverse Events

Click to Download 1.20 MB

MADRAC ADR Newsletter 2006 - December

- A study of ADRs in Malaysian Children Reported to the NPCB
- Issues of Current Interest
• 5-Hydroxytryptamine Receptor Agonists (Triptans) Selective Serotonin Reuptake Inhibitors (SSRIs) Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) Serotonin Syndrome
• Incompatibilities Ceftriaxone And Calcium.
• Possible signal of depression with Ezetimibe
• Aprotinin Injection - Trasylol®
- Local Case Reports
• Switching from Ritalin to Straterra : Suspected association with priapism.
• Lenogastrim and Fatal Acute Megakaryoblastic Anemia
• Anzapine and Increased Total White Blood Cell Count
- Current Regulatory Issues
• ACE Inhibitors and “Increased Risk Of Birth Defects, Fetal And Neonatal Morbidity And Death When Used Throughout Pregnancy”
• Arginine : Warning statement on “Not Recommended For Patients Following A Heart Attack”.
- Report from Journal
• The National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifen (STAR) Trial.

Click to Download 1.40 MB

MADRAC ADR Newsletter 2006 - September

- Ten Drugs with the Most Reported ADRs (Year 2000-2005)
- Issues of Current Interest
• Gadolinium and Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD)
• Raloxifene (EVISTA) Associated with Increased Risk of Death Due to Stroke.
• Lamotrigine and Risk of Oral Clefts
- Local Case Reports
• Suspected Hepatotoxicity Associated with the Use of Camellia Sinensis
• Carbimazole and Dysphagia
• Setraline and Cleft Palate
- Black Cohosh, Root: Warning Statement on Hepatotoxicity
- Promethazine and The Potential for Fatal Respiratory Depression
- Reports from Journals
• ACE Inhibitors and Congenital Anomalies
• Attention-Deficit Hyperactivity Disorder (ADHD) Drug Labels
- ADR monitoring: A Co-operative Programme for Enhancing the Safer Use of Medicines

Click to Download 0.33 MB

MADRAC ADR Newsletter 2006 - March

- Overview of Adverse Drug Reactions (ADR) Reports for 2005
- Summary of Regulatory Actions Taken in 2005
- Local Case Reports
• Jamu Asam Urat Jaya Asli
• Valproic acid-induced Pancreatitis in a Child
- Issues of Current Interest
• Tibolone (LIFT study)- The Increased Risk of Stroke Outweighs the Benefit of a Decreased Risk of Vertebral Fractures

Click to Download 0.36 MB



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