NPRA Safety Alerts
(Year 2024)
MADRAC Bulletin
Volume 50 Issue 05/2024
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17-HYDROXYPROGESTERONE CAPROATE (17-OHPC)
17- Hydroxyprogesterone Caproate (17-OHPC): Cancellation of Product Registration and Product Recall
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PARACETAMOL
Paracetamol and Fixed Drug Eruption (FDE): Upward Trend of Reports Involving Paediatric Patients
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FLUCONAZOLE
Updates on the Known Risk of Spontaneous Abortion During Pregnancy and Congenital Malformations in Children Exposed to Fluconazole in Utero
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PSEUDOEPHEDRINE
Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)
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MEFENAMIC ACID
Mefenamic Acid- Associated Generalised Bullous Fixed Drug Eruption (GBFDE)
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PROGESTOGENS (CYPROTERONE ACETATE, MEDROXYPROGESTERONE ACETATE, CHLORMADINONE ACETATE)
Risk of Meningioma
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Paracetamol
Fixed Drug Eruptions (FDEs) associated with paracetamol
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MADRAC Bulletin
Volume 49 Issue 04/2024
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Azacitidine (Injectable Formulation)
Risk of Cutaneous Vasculitis
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17-Hydroxyprogesterone Caproate (17-OHPC)
Potential Cancer Risk in Offspring Exposed in Utero and Limited Efficacy Data
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Hydroxychloroquine
Risk of Sweet’s Syndrome (Acute Febrile Neutrophilic Dermatosis)
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Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab)
Risk of Pyoderma Gangrenosum
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MADRAC Bulletin
Volume 48 Issue 03/2024
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Amoxicillin
Risk of Aseptic Meningitis
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Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors (Dapagliflozin, Empagliflozin, Canagliflozin)
Interaction with Lithium (for Therapeutic Use) Leading to Decreased Serum Lithium Concentration
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Olmesartan
Risk of Autoimmune Hepatitis
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Proton Pump Inhibitors
Risk of Erectile Dysfunction
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Levetiracetam and Clobazam
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
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Hydrochlorothiazide
Risk of Acute Respiratory Distress Syndrome (ARDS)
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Ciprofloxacin, Moxifloxacin, Levofloxacin and Ofloxacin (Fluoroquinolones) for Systemic Use (Oral and Injection)
Risk of Suicidal Behaviours
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MADRAC Bulletin
Volume 47 Issue 02/2024
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Domperidone
Risk of Psychiatric Withdrawal Events When Used Off-Label for Lactation Stimulation
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Metformin
Risk of Vitamin B12 Deficiency
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Statins (Atorvastatin, Rosuvastatin, Simvastatin)
Interaction with Ticagrelor Leading to Increased Risk of Rhabdomyolysis
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MADRAC Bulletin
Volume 46 Issue 01/2024
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Imatinib
Risk of Thrombotic Microangiopathy
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Rivastigmine
Risks of QT Prolongation and Torsade de Pointes
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05-Jan-2024 (No. SP PPUM: 010/2024)
Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #8
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English Version
Versi Bahasa Malaysia