NPRA Safety Alerts

(Year 2023)

29-Dec-2023 (No. SP PPUM: 634/2023)

Clomiphene

Risk of Serious Visual Disturbances Potentially Leading to Blindness


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27-Dec-2023 (No. SP PPUM: 631/2023)

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

Volume 45 Issue 06/2023


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18-Dec-2023 (No. SP PPUM: 611/2023)

Topiramate

Neurodevelopmental Disorders in Children Exposed to Topiramate during Pregnancy


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30-Nov-2023 (No. SP PPUM: 574/2023)

 Loperamide

Risk of Acute Pancreatitis


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31-Oct-2023 (No. SP PPUM: 514/2023)

 Isotretinoin

Risk of Psychiatric Disorders and Sexual Dysfunction


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13-Oct-2023 (No. SP PPUM: 477/2023)

MADRAC Bulletin

Volume 44 Issue 05/2023


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15-Sep-2023 (No. SP PPUM: 410/2023)

Cephalosporins

Risk of Seizures


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11-Sep-2023 (No. SP PPUM: 401/2023)

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)

Tendon Disorders


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04-Sep-2023 (No. SP PPUM: 382/2023)

MADRAC Bulletin

Volume 43 Issue 04/2023


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30-Aug-2023 (No. SP PPUM: 381/2023)

Statins

Risk of Inducing or Aggravating Myasthenia Gravis


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21-Aug-2023 (No. SP PPUM: 357/2023)

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)

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)

Risk of Acute Kidney Injury


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10-May-2023 (No. SP PPUM: 197/2023)

Griseofulvin

Risk of Severe Cutaneous Adverse Reactions (SCARs)


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05-May-2023 (No. SP PPUM: 189/2023)

Comirnaty Vaccine

Risk of Heavy Menstrual Bleeding


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04-Apr-2023 (No. SP PPUM: 155/2023)

MADRAC Bulletin

Volume 41 Issue 02/2023


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28-Mar-2023 (No. SP PPUM: 143/2023)

Topiramate

Neurodevelopmental Disorders in Children Exposed to Topiramate During Pregnancy


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20-Mar-2023 (No. SP PPUM: 125/2023)

Pholcodine

Risk of Anaphylaxis to Neuromuscular Blocking Agents (NMBAs)


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22-Feb-2023 (No. SP PPUM: 088/2023)

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

Volume 40 Issue 01/2023


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27-Jan-2023 (No. SP PPUM: 038/2023)

MADRAC Bulletin

Volume 39 Issue 03/2022


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17-Jan-2023 (No. SP PPUM: 017/2023)

Donepezil

Risk of QT Prolongation and Torsade de Pointes


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