NPRA Safety Alerts
(Year 2023)
Embedded Files
UMMC Antimicrobial Guidelines, 3rd Edition (2024) is now available!
29-Dec-2023 (No. SP PPUM: 634/2023)
Clomiphene
Clomiphene
Risk of Serious Visual Disturbances Potentially Leading to Blindness
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27-Dec-2023 (No. SP PPUM: 631/2023)
Ibrutinib (IMBRUVICAⓇ)
Ibrutinib (IMBRUVICAⓇ)
Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use
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19-Dec-2023 (No. SP PPUM: 616/2023)
MADRAC Bulletin
MADRAC Bulletin
Volume 45 Issue 06/2023
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18-Dec-2023 (No. SP PPUM: 611/2023)
Topiramate
Topiramate
Neurodevelopmental Disorders in Children Exposed to Topiramate during Pregnancy
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30-Nov-2023 (No. SP PPUM: 574/2023)
 Loperamide
 Loperamide
Risk of Acute Pancreatitis
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31-Oct-2023 (No. SP PPUM: 514/2023)
 Isotretinoin
 Isotretinoin
Risk of Psychiatric Disorders and Sexual Dysfunction
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13-Oct-2023 (No. SP PPUM: 477/2023)
MADRAC Bulletin
MADRAC Bulletin
Volume 44 Issue 05/2023
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15-Sep-2023 (No. SP PPUM: 410/2023)
Cephalosporins
Cephalosporins
Risk of Seizures
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11-Sep-2023 (No. SP PPUM: 401/2023)
Valaciclovir
Valaciclovir
Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
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07-Sep-2023 (No. SP PPUM: 396/2023)
Third-Generation Aromatase Inhibitors(Anastrozole; Exemestane; Letrozole)
Third-Generation Aromatase Inhibitors(Anastrozole; Exemestane; Letrozole)
Tendon Disorders
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04-Sep-2023 (No. SP PPUM: 382/2023)
MADRAC Bulletin
MADRAC Bulletin
Volume 43 Issue 04/2023
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30-Aug-2023 (No. SP PPUM: 381/2023)
Statins
Statins
Risk of Inducing or Aggravating Myasthenia Gravis
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21-Aug-2023 (No. SP PPUM: 357/2023)
Terlipressin (GlypressinⓇ)
Terlipressin (GlypressinⓇ)
Serious or Fatal Respiratory Failure and Sepsis/Septic Shock in Patients with Type 1 Hepatorenal Syndrome (Type 1 HRS)
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18-Aug-2023 (No. SP PPUM: 352/2023)
18-Aug-2023 (No. SP PPUM: 352/2023)
Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #7
Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #7
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English Version
Versi Bahasa Malaysia
17-Aug-2023 (No. SP PPUM: 350/2023)
Clindamycin (Systemic)
Clindamycin (Systemic)
Risk of Acute Kidney Injury
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10-May-2023 (No. SP PPUM: 197/2023)
Griseofulvin
Griseofulvin
Risk of Severe Cutaneous Adverse Reactions (SCARs)
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05-May-2023 (No. SP PPUM: 189/2023)
Comirnaty Vaccine
Comirnaty Vaccine
Risk of Heavy Menstrual Bleeding
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04-Apr-2023 (No. SP PPUM: 155/2023)
MADRAC Bulletin
MADRAC Bulletin
Volume 41 Issue 02/2023
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28-Mar-2023 (No. SP PPUM: 143/2023)
Topiramate
Topiramate
Neurodevelopmental Disorders in Children Exposed to Topiramate During Pregnancy
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20-Mar-2023 (No. SP PPUM: 125/2023)
Pholcodine
Pholcodine
Risk of Anaphylaxis to Neuromuscular Blocking Agents (NMBAs)
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22-Feb-2023 (No. SP PPUM: 088/2023)
22-Feb-2023 (No. SP PPUM: 088/2023)
Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #6
Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #6
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English Version
Versi Bahasa Malaysia
20-Feb-2023 (No. SP PPUM: 085/2023)
MADRAC Bulletin
MADRAC Bulletin
Volume 40 Issue 01/2023
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27-Jan-2023 (No. SP PPUM: 038/2023)
MADRAC Bulletin
MADRAC Bulletin
Volume 39 Issue 03/2022
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17-Jan-2023 (No. SP PPUM: 017/2023)
Donepezil
Donepezil
Risk of QT Prolongation and Torsade de Pointes
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