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