NPRA Safety Alerts

(Year 2022)

21-Dec-2022 (No. SP PPUM: 573/2022)

Pneumococcal Polysaccharide Vaccine (23-Valent)

Extensive Swelling of Vaccinated Limb


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12-Dec-2022 (No. SP PPUM: 557/2022)

Sorafenib

Risk of Thrombotic Microangiopathy (TMA)


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07-Dec-2022 (No. SP PPUM: 549/2022)

Hydroxychloroquine and Chloroquine

Risk of Hepatic Impairment


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17-Nov-2022 (No. SP PPUM: 511/2022)

Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #5

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English Version

Versi Bahasa Malaysia

08-Nov-2022 (No. SP PPUM: 481/2022)

Piperacillin

Risk of Haemophagocytic Lymphohistiocytosis (HLH)


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04-Nov-2022 (No. SP PPUM: 477/2022)

COVID-19 Vaccines

Risk of Tinnitus


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31-Oct-2022 (No. SP PPUM: 468/2022)

Iodinated Contrast Media

Risk of Hypothyroidism (Particularly in Newborns and Young Children)


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25-Oct-2022 (No. SP PPUM: 452/2022)

Labetalol

Risk of Nipple Pain and Raynaud's Phenomenon of the Nipple


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19-Oct-2022 (No. SP PPUM: 446/2022)

Sertraline

Risk of Microscopic Colitis


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07-Oct-2022 (No. SP PPUM: 434/2022)

Nirmatrelvir / Ritonavir (PAXLOVID)

Risk of Anaphylaxis and Hypersensitivity Reactions


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04-Oct-2022 (No. SP PPUM: 422/2022)

Alectinib (AlecensaⓇ)

Risk of Haemolytic (New Warning and Precaution and Dose Modification Guidance)


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30-Sep-2022 (No. SP PPUM: 417/2022)

Metformin

Risk of Vitamin B12 Deficiency


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10-Aug-2022 (No. SP PPUM: 330/2022)

Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #4

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25-Jul-2022 (No. SP PPUM: 313/2022)

Corticosteroids (Systemic)

Risk of Pheochromocytoma Crisis


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22-Jul-2022 (No. SP PPUM: 306/2022)

Chloroquine and Hydroxychloroquine

Risk of Psychiatric Disorders


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21-Jul-2022 (No. SP PPUM: 304/2022)

Azathioprine

Risk of Erythema Nodosum


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24-Jun-2022 (No. SP PPUM: 260/2022)

Loperamide

Risk of Acute Pancreatitis


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23-Jun-2022 (No. SP PPUM: 255/2022)

Olmesartan

Risk of Autoimmune Hepatitis


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14-Jun-2022 (No. SP PPUM: 244/2022)

Mavenclad® (Cladribine)

Risk of Serious Liver Injury and New Recommendations About Liver Function Monitoring


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18-May-2022 (No. SP PPUM: 192/2022)

Safety Updates on Covid-19 Vaccines

Risk of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) / Thrombosis with Thrombocytopenia Syndrome (TTS)


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12-May-2022 (No. SP PPUM: 183/2022)

Warfarin

Risk of Anticoagulant-Related Nephropathy (ARN)


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10-May-2022 (No. SP PPUM: 174/2022)

Hydrochlorothiazide, Chlorthalidone, Indapamide and Acetazolamide

Risk of Choroidal Effusion, Acute Myopia and Acute Angle-Closure Glaucoma


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09-May-2022 (No. SP PPUM: 173/2022)

Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #3

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08-Apr-2022 (No. SP PPUM: 130/2022)

Betamethasone (Systemic)

Risk of Pheochromocytoma Crisis


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24-Mar-2022 (No. SP PPUM: 110/2022)

Tenofovir Alafenamide

Risk of Acute Renal Adverse Effects


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22-Mar-2022 (No. SP PPUM: 105/2022)

Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia #2

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20-Jan-2022 (No. SP PPUM: 025/2022)

Clindamycin

Risk of Acute Renal Failure


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20-Jan-2022 (No. SP PPUM: 020/2022)

Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis Patients

Risk of Major Adverse Cardiovascular Events (MACE) and Malignancies [Excluding Non-Melanoma Skin Cancer (NMSC)]


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15-Nov-2022 (No. SP PPUM: 499/2022)

Methadone

Risk of Hypoglycaemia


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