Health Professionals
Safety Alert
Written by kobu
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Safety information
Safety alerts.
Signals, reviews and warnings issued to healthcare professionals, filed by the year of issue.
2026
- 6 Jul 2026 Aciclovir (Oral/Injectable) and Valaciclovir: Risk of Acute Generalised Exanthematous Pustulosis (AGEP)
- 6 Jul 2026 Cefazolin: Risk of Kounis Syndrome
- 6 Jul 2026 Lamotrigine: Risk of Photosensitivity Reactions
- 13 May 2026 Clindamycin Hydrochloride (Oral Capsules): Risk of Oesophagitis and Oesophageal Ulcer
- 7 May 2026 Mesalazine: Risk of Idiopathic Intracranial Hypertension (IIH)
- 30 Apr 2026 Sunitinib: Risk of Hyperammonaemic Encephalopathy
- 30 Apr 2026 Moxifloxacin: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Fixed-Drug Eruption (FDE), and Photosensitivity Associated with Systemic Use
- 19 Mar 2026 Denosumab (Prolia®) and Biosimilars: Multi Vertebral Fractures (MVF) after Discontinuation of Denosumab – Strengthened Warnings
- 10 Feb 2026 Linezolid: Risk of Rhabdomyolysis
- 10 Feb 2026 Palbociclib: Risk of Venous Thromboembolism
- 27 Jan 2026 Garcinia Cambogia and Hydroxycitric Acid: Risk of Hepatotoxicity
- 27 Jan 2026 Vitamin B6 (Pyridoxine): Risk of Peripheral Neuropathy
- 22 Jan 2026 Prescription Opioid: Risk of Oesophageal Dysfunction
2025
- 17 Nov 2025 Cyclin-Dependent Kinase Inhibitors (CDKIs): Interaction with Statins Leading to Potential Risk of Rhabdomyolysis
- 14 Nov 2025 Amiodarone: Risk of Primary Graft Dysfunction after Heart Transplantation
- 14 Nov 2025 [Updated] Sulfamethoxazole, Trimethoprim (Cotrimoxazole): Risk of Circulatory Shock
- 14 Nov 2025 Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Risk of Persistent Sexual Dysfunction
- 13 Oct 2025 Safety Signal Alert: Doxycycline-Fixed Drug Eruption (FDE)
- 24 Sep 2025 Finasteride and Dutasteride: Risk of Suicidal Thoughts
- 19 Sep 2025 [Updated] Hydroxychloroquine: 1) Small Increased Risk of Major Congenital Malformations in Children Following in utero Exposure; 2) Risk of Drug-Induced Phospholipidosis; 3) Risk of Aggravation of Myasthenia Gravis
- 17 Sep 2025 Safety Signal Alert: Lamotrigine-Erythema Multiforme (EM)
- 17 Sep 2025 [Updated] Progestogens (Cyproterone Acetate, Medroxyprogesterone Acetate, Chlormadinone): Risk of Meningioma
- 22 Aug 2025 Oral Anticoagulants (Apixaban, Dabigatran, Edoxaban, Rivaroxaban and Warfarin): Risk of Atraumatic Splenic Rupture
- 19 Aug 2025 Valproate (Sodium Valproate, Valproic Acid): Potential Risks to Offspring Following Paternal Exposure, and Male Infertility
- 4 Jul 2025 Rituximab: Risks of Enteroviral Meningoencephalitis and False-Negative Serologic Testing of Infections
- 28 May 2025 Angiotensin II Receptor Blockers (ARBs): Risk of Intestinal Angioedema
- 26 May 2025 Isotretinoin: Risk of Sacroiliitis and Urethritis
- 26 May 2025 [Updated] Statins: Risk of Inducing or Aggravating Myasthenia Gravis
- 21 May 2025 Enoxaparin: Risk of Acute Generalised Exanthematous Pustulosis (AGEP)
- 20 May 2025 Azathioprine: Risk of Non-Cirrhotic Portal Hypertension (NCPH) / Portosinusoidal Vascular Disease (PVSD)
- 24 Apr 2025 Azithromycin: Rare Risk of Cardiovascular Death
- 4 Mar 2025 Hydroxychloroquine: Small Increased Risk of Major Congenital Malformations in Children Following in utero Exposure
- 21 Jan 2025 [Updated] Glucagon-like Peptide-1 (GLP-1) Receptor Agonists (Dulaglutide, Liraglutide, Lixisenatide, Semaglutide, and Tirzepatide): Aspiration and Pneumonia Aspiration during General Anaesthesia or Deep Sedation
- 9 Jan 2025 Ethambutol: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
2024
- 14 Oct 2024 [Updated] 17-Hydroxyprogesterone Caproate (17-OHPC): Cancellation of Product Registration and Product Recall
- 10 Oct 2024 Paracetamol and Fixed Drug Eruption (FDE): Upward Trend of Reports Involving Paediatric Patients
- 1 Oct 2024 Fluconazole: Updates on the Known Risk of Spontaneous Abortion During Pregnancy and Congenital Malformations in Children Exposed to Fluconazole in Utero
- 30 Sep 2024 Pseudoephedrine: Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)
- 2 Sep 2024 Safety Signal Alert: Mefenamic Acid-Associated Generalised Bullous Fixed Drug Eruption (GBFDE)
- 25 Aug 2024 Progestogens (Cyproterone Acetate, Medroxyprogesterone Acetate, Chlormadinone): Risk of Meningioma
- 12 Aug 2024 Azacitidine (Injectable Formulation): Risk of Cutaneous Vasculitis
- 22 Jul 2024 17-Hydroxyprogesterone Caproate (17-OHPC): Potential Cancer Risk in Offspring Exposed in Utero and Limited Efficacy Data
- 15 Jul 2024 Hydroxychloroquine: Risk of Sweet’s Syndrome (Acute Febrile Neutrophilic Dermatosis)
- 28 Jun 2024 Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab): Risk of Pyoderma Gangrenosum
- 29 May 2024 Amoxicillin: Risk of Aseptic Meningitis
- 28 May 2024 Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors (Dapagliflozin, Empagliflozin, Canagliflozin): Interaction with Lithium (for Therapeutic Use) Leading to Decreased Serum Lithium Concentration
- 6 May 2024 [Updated] Olmesartan: Risk of Autoimmune Hepatitis
- 30 Apr 2024 Proton Pump Inhibitors: Risk of Erectile Dysfunction
- 29 Apr 2024 Levetiracetam and Clobazam: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- 18 Apr 2024 Hydrochlorothiazide: Risk of Acute Respiratory Distress Syndrome (ARDS)
- 17 Apr 2024 Ciprofloxacin, Moxifloxacin, Levofloxacin and Ofloxacin (Fluoroquinolones) for Systemic Use (Oral and Injection): Risk of Suicidal Behaviours
- 12 Mar 2024 Domperidone: Risk of Psychiatric Withdrawal Events When Used Off-Label for Lactation Stimulation
- 4 Mar 2024 [Updated] Metformin: Risk of Vitamin B12 Deficiency
- 19 Feb 2024 Statins (Atorvastatin, Rosuvastatin, Simvastatin): Interaction with Ticagrelor Leading to Increased Risk of Rhabdomyolysis
- 22 Jan 2024 Imatinib: Risk of Thrombotic Microangiopathy
- 19 Jan 2024 Rivastigmine: Risks of QT Prolongation and Torsade de Pointes
2023
- 1 Dec 2023 Clomiphene: Risk of Serious Visual Disturbances Potentially Leading to Blindness
- 29 Nov 2023 [Updated] Loperamide: Risk of Acute Pancreatitis
- 28 Nov 2023 [Updated] Topiramate: Neurodevelopmental Disorders in Children Exposed to Topiramate during Pregnancy
- 13 Oct 2023 Isotretinoin: Risk of Psychiatric Disorders and Sexual Dysfunction
- 5 Sep 2023 Cephalosporins: Risk of Seizures
- 23 Aug 2023 Valaciclovir: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- 7 Aug 2023 [Updated] Clindamycin (Systemic): Risk of Acute Kidney Injury
- 2 Aug 2023 Third-Generation Aromatase Inhibitors (Anastrozole; Exemestane; Letrozole): Risk of Tendon Disorders
- 18 Jul 2023 Statins: Risk of Inducing or Aggravating Myasthenia Gravis
- 3 May 2023 Griseofulvin: Risk of Severe Cutaneous Adverse Reactions (SCARs)
- 2 May 2023 Comirnaty Vaccine: Risk of Heavy Menstrual Bleeding
- 19 Apr 2023 Azacitidine: Risk of Differentiation Syndrome
- 11 Apr 2023 Off-Label Use of Diclofenac Suppositories to Treat Fever in Children: Potential Risk of Acute Necrotising Encephalopathy of Childhood (ANEC)
- 23 Mar 2023 [Updated] Pholcodine: Risk of Anaphylaxis to Neuromuscular Blocking Agents (NMBAs)
- 16 Jan 2023 Donepezil: Risk of QT Prolongation and Torsade de Pointes
2022
- 20 Dec 2022 Pneumococcal Polysaccharide Vaccine (23-Valent): Extensive Swelling of Vaccinated Limb
- 9 Dec 2022 Sorafenib: Risk of Thrombotic Microangiopathy (TMA)
- 6 Dec 2022 Hydroxychloroquine and Chloroquine: Risk of Hepatic Impairment
- 2 Nov 2022 Methadone: Risk of Hypoglycaemia
- 31 Oct 2022 Piperacillin: Risk of Haemophagocytic Lymphohistiocytosis (HLH)
- 27 Oct 2022 Iodinated Contrast Media: Risk of Hypothyroidism (Particularly in Newborns and Young Children)
- 20 Oct 2022 Safety Updates on COVID-19 Vaccines: Risk of Tinnitus
- 19 Oct 2022 Labetalol: Risk of Nipple Pain and Raynaud's Phenomenon of the Nipple
- 17 Oct 2022 Sertraline: Risk of Microscopic Colitis
- 5 Oct 2022 Nirmatrelvir/ Ritonavir (PAXLOVID): Risk of Anaphylaxis and Hypersensitivity Reactions
- 27 Sep 2022 Metformin: Risk of Vitamin B12 Deficiency
- 19 Jul 2022 Chloroquine and Hydroxychloroquine: Risk of Psychiatric Disorders
- 19 Jul 2022 Corticosteroids (Systemic): Risk of Pheochromocytoma Crisis
- 18 Jul 2022 Azathioprine: Risk of Erythema Nodosum
- 23 Jun 2022 Loperamide: Risk of Acute Pancreatitis
- 20 Jun 2022 Empagliflozin: Risk of Tubulointerstitial Nephritis
- 16 Jun 2022 Olmesartan: Risk of Autoimmune Hepatitis
- 17 May 2022 Safety Updates on COVID-19 Vaccines: Risk of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) / Thrombosis with Thrombocytopenia Syndrome (TTS)
- 6 May 2022 Warfarin: Risk of Anticoagulant-Related Nephropathy (ARN)
- 5 May 2022 Hydrochlorothiazide, Chlorthalidone, Indapamide and Acetazolamide: Risk of Choroidal Effusion, Acute Myopia & Acute Angle-Closure Glaucoma
- 6 Apr 2022 Betamethasone (Systemic): Risk of Pheochromocytoma Crisis
- 21 Mar 2022 Tenofovir Alafenamide: Risk of Renal Adverse Effects
- 3 Jan 2022 Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis Patients: Risk of Major Adverse Cardiovascular Events (MACE) and Malignancies [Excluding Non-Melanoma Skin Cancer (NMSC)]
2021
- 31 Dec 2021 Clindamycin: Risk of Acute Renal Failure
- 31 Dec 2021 Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis Patients: Risk of Major Adverse Cardiovascular Events (MACE) and Malignancies [Excluding Non-Melanoma Skin Cancer (NMSC)]
- 30 Dec 2021 Sulfamethoxazole & Trimethoprim (Co-Trimoxazole): Risk of Acute Respiratory Distress Syndrome (ARDS)
- 14 Dec 2021 Decitabine: Risk of Differentiation Syndrome
- 29 Nov 2021 Anastrozole: Risk of Depression
- 12 Oct 2021 Bortezomib: Risk of Guillain-Barré Syndrome and Demyelinating Polyneuropathy
- 7 Oct 2021 Non-Vitamin K Antagonist Oral Anticoagulants (NOACs): Risk of Abnormal Uterine Bleeding
- 9 Sep 2021 Sacubitril/Valsartan: Risk of Psychiatric Events
- 29 Jul 2021 Mycophenolate Mofetil (MMF) and Myocophenolic Acid (MPA): Risk of De Novo Purine Synthesis Inhibitors-Associated Acute Inflammatory Syndrome
- 8 Jul 2021 Oseltamivir: Risk of Haemorrhages
- 22 Apr 2021 Antidepressants (citalopram; desvenlafaxine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine; vortioxetine): Risk of Postpartum Haemorrhage (PPH)
- 20 Apr 2021 Ceftriaxone: Risk of encephalopathy
- 20 Apr 2021 Mirtazapine: Risks of (i) Amnesia and (ii) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- 20 Apr 2021 Vascular endothelial growth factor (VEGF) inhibitors for systemic use (except application on eyes): Risk of artery dissections and aneurysms
- 17 Feb 2021 Safety Updates on COVID-19 Vaccine (Comirnaty®)
- 29 Jan 2021 Abiraterone: Risk of hypoglycaemia due to drug interaction
- 29 Jan 2021 Clozapine: Risk of serious bowel complications caused by constipation
- 29 Jan 2021 Oseltamivir: Thrombocytopenia
- 29 Jan 2021 Mesalazine and sulfasalazine: Nephrolithiasis
- 29 Jan 2021 Efavirenz (including combination products): Risk of late onset neurotoxicity
- 20 Jan 2021 Tumour Necrosis Factor alpha (TNFα): Kaposi’s Sarcoma
- 20 Jan 2021 Ondansetron: Information updates on risk of birth defects
2020
- 14 Dec 2020 Esmya (ulipristal acetate 5 mg): Withdrawal of product registration
- 27 Aug 2020 Parenteral nutrition containing amino acids and/or lipids: Risk of toxic degradations of ingredients when exposed to light, which may lead to adverse outcomes in paediatric patients less than 2 years of age
- 25 Aug 2020 Propofol: Risk of priapism
- 6 Aug 2020 Insulin: Risk of cutaneous amyloidosis
- 6 Aug 2020 Topiramate: Risk of uveitis
- 23 Jun 2020 Reminder on the risk of oculogyric crisis with metoclopramide use
- 4 Jun 2020 Domperidone: Restriction of use in paediatric patients less than 12 years of age
- 28 May 2020 Proton pump inhibitors: Risk of microscopic colitis
- 27 May 2020 Gabapentin: Risk of dysphagia
- 12 May 2020 Nintedanib: Ischaemic colitis
- 12 May 2020 Rocuronium: Kounis syndrome
- 7 Apr 2020 Guselkumab: Risk of anaphylaxis
- 6 Apr 2020 Nivolumab: Reports of cytomegalovirus (CMV) infection or reactivation
- 6 Apr 2020 Intravenous iron-containing products: Kounis syndrome
- 6 Apr 2020 Esmya (ulipristal acetate 5 mg): Product recall due to potential risk of liver injury
- 26 Feb 2020 Cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors: Risk of severe lung inflammation
- 26 Feb 2020 Ondansetron: Birth defects
- 26 Feb 2020 Sulfasalazine: Interference with dihydronicotinamide-adenine dinucleotide/ dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADPH) reaction assays
- 20 Jan 2020 New safety measure for sodium valproate: (i) Risk of congenital malformation in neonates and neurodevelopmental problems in children exposed to sodium valproate during pregnancy; (ii) Additional educational material for healthcare professionals and patien
2019
- 26 Nov 2019 Retinoids: Updated measures for pregnancy prevention during retinoids use
- 3 Sep 2019 Clopidogrel: Interaction with boosted antiviral Human Immunodeficiency Virus (HIV) therapy leading to insufficient inhibition of platelet aggregation
- 26 Aug 2019 Diclofenac (systemic use): (i) Risk of anastomotic leakage and (ii) Risk of Kounis syndrome
- 20 Jun 2019 Posaconazole: Pseudohyperaldosteronism
- 12 Jun 2019 DARZALEX (daratumumab): New identified risk of Hepatitis B Virus reactivation
- 12 Jun 2019 Deferiprone: Risk of neurological disorders in children
- 9 Apr 2019 Carbimazole and methimazole (thiamazole): (i) Risk of birth defects and neonatal disorders in case of exposure during pregnancy; (ii) Risk of pancreatitis
- 4 Apr 2019 Tapentadol: Risk of seizures and reports of serotonin syndrome when co-administered with other drugs
- 4 Apr 2019 Oral retinoids: Risk of neuropsychiatric symptoms
- 15 Mar 2019 Direct-Acting Antivirals (DAAVs) : Risk of hypoglycaemia in patients with diabetes
- 15 Mar 2019 Xylometazoline: Increased risk of serious ventricular arrhythmia in patients with long QT syndrome
- 31 Jan 2019 Fluoroquinolones: Risk of aortic aneurysm and dissection
- 31 Jan 2019 Acetazolamide: A new contraindication during pregnancy
- 31 Jan 2019 Beta-Lactam antibiotics: Severe Cutaneous Adverse Reactions (SCARs)
- 31 Jan 2019 Ceftriaxone: Disturbed consciousness, convulsions or involuntary movements
- 31 Jan 2019 Lamotrigine: Risk of hemophagocytic lymphohistiocytosis (HLH)
2018
- 26 Oct 2018 Eltrombopag: Risk of interference with bilirubin and creatinine test results
- 26 Oct 2018 Succinylated gelatin (modified fluid gelatin): Possible cross-reactions involving the allergen galactose-alpha-1,3-galactose (Alpha-gal)
- 10 Oct 2018 Apixaban: Drug interaction between apixaban and Selective Serotonin Reuptake Inhibitors (SNRI) and/or Serotonin and Noradrenaline Reuptake Inhibitors (SNRI) leading to increased risk of bleeding
- 10 Oct 2018 Azithromycin, clarithromycin, erythromycin and roxithromycin: Risk of Severe Cutaneous Adverse Reactions (SCAR)
- 10 Oct 2018 Saccharomyces boulardii: Risk of fungaemia
- 10 Oct 2018 Isoniazid: Risk of pancreatitis
- 10 Oct 2018 Montelukast sodium: Update on neuropsychiatric adverse reactions – obsessive-compulsive symptoms
- 10 Oct 2018 Varenicline tartrate: Loss of consciousness
- 28 Aug 2018 Iodinated Contrast Media: Risk of Severe Cutaneous Adverse Reactions (SCAR)
- 29 Jul 2018 Domperidone and clarithromycin: Drug interaction leading to increased risk of QT interval prolongation
- 29 Jul 2018 Noradrenaline: Stress cardiomyopathy
- 25 Jun 2018 Acetazolamide: Risk of Severe Cutaneous Adverse Reactions (SCARs)
- 25 Jun 2018 Carbocisteine and acetylcysteine: Anaphylactic/anaphylactoid reactions and Severe Cutaneous Adverse Reactions (SCARs)
- 25 Jun 2018 Efavirenz: Risk of QTc interval prolongation
- 16 Jun 2018 Drug interaction of oral contraceptives containing ethinylestradiol with the direct-acting antiviral combinations of paritaprevir, ritonavir and ombitasvir with or without dasabuvir
- 15 Jun 2018 Mesalazine: Risk of photosensitivity reactions
- 13 Jun 2018 Methotrexate: Pulmonary alveolar haemorrhage
- 12 Jun 2018 Pemetrexed: Risk of nephrogenic diabetes insipidus and renal tubular necrosis
- 11 Jun 2018 Amoxicillin-containing products: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and strengthening the risk of Severe Cutaneous Adverse Reactions (SCARs)
- 10 Jun 2018 Propofol and sodium valproate: Risk of increased propofol blood level when co-administered with valproate
- 23 Mar 2018 Levetiracetam and methotrexate: Risk of drug-drug interaction
- 23 Mar 2018 Intravenous (IV) fluids containing electrolytes and/or carbohydrates: Risk of hyponatraemia
- 23 Mar 2018 Gadolinium-based Contrast Agents: Suspension/restriction of use following evidence of gadolinium deposits in the brain after magnetic resonance imaging (MRI) body scans
- 23 Mar 2018 Doxycycline: Risk of Jarisch-Herxheimer reaction