Health Professional Alerts

Last Updated on September 9, 2023

DRAP’s issues safety updates and alerts related to the therapeutic goods in order to ensure that healthcare professionals and other stakeholders have timely access to the relevant information on safety, quality and efficacy issues or benefit/risk evaluations of the drugs, vaccines and medical devices. Such information updates are issues time to time from the DRAP, and mainly includes the new scientific and regulatory information updates in line with the principles of reliance on the information generated by the reference regulatory authorities on the safety and efficacy of therapeutic goods.

Therapeutic products requires continuous monitoring to evaluate the benefits-risk ratio throughout the lifecycle, to mitigate and minimize any known or suspected risks associated with them. This section includes information updates primarily for healthcare professionals (physicians, pharmacists, nurses, etc) and other stakeholders to provides an insight on the benefit / risk assessment of the products including the information on how to identify and mitigate the risks, and possible actions which can be taken by the healthcare professionals. These communications are aimed at assisting healthcare professionals and consumers to make informed decisions about their use of therapeutic goods..

The following section provides the list of product safety updates issued.

Issued OnAlert Titles
April 27, 2024Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS) with Pseudoephedrine Containing Medicines.View
April 27, 2024Risk of Haemophagocytic Lymphohistiocytosis (HLH) with
Sulfamethoxazole and Trimethoprim combination.
April 27, 2024 Risk of Myasthenia Gravis and Ocular Myasthenia with StatinsView
April 24, 2024Risk of Ocular Adverse Events with Miltefosine. View
April 24, 2024Risk of Neurodevelopmental Disorders in Children during
Pregnancy with Topiramate
April 24, 2024Risk of Rare and Serious Drug Reaction with Eosinophilia and
Systemic Symptoms (DRESS) reaction with Levetiracetam and Clobazam
October 20, 2023 Risk of Kidney Damage with Oral Anticoagulants.View
October 26, 2023Risk of Potentially Life-threatening Toxicity with Fluorouracil and Capecitabine in Di-hydropyrimidine Dehydrogenase (DPD) Deficient Patients.view
October 20, 2023Risk of Kidney Damage with Oral Anticoagulantsview
October 20, 2023Risk of Seizures with Cephalosporinsview
October 20, 2023Risk of Tendon Disorders with Third-Generation Aromatase inhibitorsview
October 20, 2023Risk of Respiratory Failure and Sepsis with Terlipressin.view
October 20, 2023Risk of Serious Renal and Gastrointestinal Harms with Codeine plus Ibuprofen Drug Combination.view
April 11, 2023Potential risk of suicidal ideation/thoughts & self-injury with FinasterideView
April 11, 2023Risk of complex sleep behaviours with ZolpidemView
April 11, 2023Risk of serious heart-related events, blood clots, cancer and death with Xeljanz (Tofacitinib)View
April 10, 2023Potential Risk of Abuse, Dependence and Withdrawal with BenzodiazepinesView
April 10, 2023Risk of dental problems with orally dissolved BuprenorphineView
April 10, 2023Risk of Hypersensitivity Reactions with Pegaspargase (Peg L Asparaginase)View
November 29, 2022Risk of Kidney Injury and Death due to Hydroxyethyl-Starch Solutions for Infusion.View
November 29, 2022Increased Risk of Cardiovascular Events with Co-administration and Interaction Between Hydroxychloroquine or Chloroquine, and Macrolide AntibioticsView
November 29, 2022Risk of Major Congenital Malformations with PregabalinView
November 23, 2022Risk of Reduced Vitamin B12 Level with Metformin and Metformin-Containing MedicinesView
November 23, 2022Risk of Severe Cutaneous Adverse Reactions (SCARs) with AtezolizumabView
November 19, 2022 Risk of Hypothyroidism in Babies and Young Children with Iodinated Contrast Media (ICM) InjectionsView
November 18, 2022 Drug Safety Update: Risk of Infusion-Related Hypersensitivity Reactions with RemdesivirView
November 18, 2022 Risk of Serious Bowl complications with clozapineView
November 10, 2022 Risk of Anaphylactic Reaction / Anaphylactic Shock with Diclofenac Sodium InjectionView
October 12, 2022WHO Global Alert on Contaminated Pediatrics Cough Syrups Identified In Gambia-West AfricaView
June 15, 2022Suspension of Drug Registration: Tablets of Diclofenac Potassium in Strengths of 75mg and 100mgView
June 15, 2022Suspension of Drug Registration: Famotidine Liquid Suspension in the Strengths of 10mg/5mL and 40mg/mLView
June 15, 2022Suspension of Drug Registration: Combination of Paracetamol, Thioridazine and CaffeineView
September 10, 2021Risk of Serious Heart Related Events, Cancer, Blood Clots, and Death With Tofacitinib
June 04, 2020Safety Alert of Falsified and Contaminated Defibrotide Identified in WHO RegionsView
May 06, 2020Safety Alert of Detection of NDMA in Ranitidine Containing MedicinesView
April 15, 2020Safety Alert of Falsified Chloroquine Products Circulating in the WHO Region of AfricaView
April 14, 2020Safety Alert of Falsified Medical Products, including In Vitro Diagnostics, that claim to Prevent, Detect, Treat or Cure COVID-19View
April 06, 2020Safety Alerts - Serious Mental Health Side Effects with Asthma and Allergic Drugs MontelukastView
March 13, 2020Safety Alerts of Falsified Anti-malarial in West and Central Africa Displaying an Outdated WHO Essential Drugs Programme LogoView
February 11, 2020 Safety Alert - Quality Defect in LPV Vaccine Imported from IndiaView
November 06, 2019Alert of Falsified Amoxicillin + Clavulanic Acid Products Circulating In HaitiView
October 18, 2019Alert of Falsified Quinine Bisulphate: Circulating In Uganda And Quinine Sulphate Circulating In Central African Republic And ChadView
October 17, 2019Safety Alert Of Risk Of Serious Cardiac Adverse Events Associated With Domperidone In Children Under 12 Years Of AgeView
October 02, 2019Detection Of NDMA In Ranitidine MedicinesView