User Rating: 3 / 5

Year 2025 

Year 2024 

Year 2023  

Year 2022  

Year 2021     

Year 2020 

Year 2019 

Year 2018 

Year 2017

New Products Approved Archived

User Rating: 5 / 5

To receive the latest issues of Direct Healthcare Professional Communications (DHPCs), you may join the NPRA Safety Information Mailing List by completing the subscription form at https://forms.office.com/r/kQKikSVYdK

• 2023
  • IMBRUVICA®(Ibrutinib): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use 2023-11-30
  • GLYPRESSIN® (Terlipressin): Serious or Fatal Respiratory Failure and Sepsis/Septic Shock in Patients with Type 1 Hepatorenal Syndrome (Type 1 HRS) 2023-06-13
• 2022
  • ALECENSA® (Alectinib): Risk of Haemolytic Anaemia (New Warning and Precaution and Dose Modification Guidance) 2022-09-28
  • MAVENCLAD® (Cladribine): Risk of Serious Liver Injury and New Recommendations About Liver Function Monitoring 2022-06-13
• 2021
  • TECENTRIQ® (Atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) 2021-04-22
  • LEMTRADA® (Alemtuzumab): Revised indication, additional contraindications and risk minimisation measures 2021-01-20
• 2020
  • GILENYA® (fingolimod): New contraindication in pregnant women and in women of childbearing potential who are not using effective contraception 2020-09-08
  • PLAQUENIL® (hydroxycholoroquine): Risk of QT prolongation and other drug-drug interactions in the context of COVID-19 management 2020-08-14
  • KYPROLI® (Carfilzomib): (i) Risk of progressive multifocal leukoencephalopathy (PML); (ii) Risk of hepatitis B virus (HBV) reactivation  2020-04-06
  • ESBRIET® (Pirfenidone): Drug-Induced Liver Injury (DILI) 2020-04-06
• 2019
  • FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study 2019-11-26
  • SMECTA® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women 2019-10-30
  • LEMTRADA® (alemtuzumab): (i) Risk of autoimmune hepatitis (ii) Other serious reactions temporally associated with alemtuzumab infusion (iii) Haemophagocytic lymphohistiocytosis 2019-09-03
  • ACTEMRA® (tocilizumab): New important identified risk of hepatotoxicity 2019-08-26
  • IMOVANE® (zopiclone): New restriction of the indication and additional warnings on abuse and dependence 2019-06-20
  • TECENTRIQ® (Atezolizumab): A new important identified risk – immune-related myositis 2019-06-20
  • BENLYSTA® (belimumab): Increased risk of serious psychiatric events 2019-06-12
  • EPILIM® (Sodium Valproate): Important new restrictions on use 2019-01-31
• 2018
  • TIVICAY® (dolutegravir): Reports of neural tube defects 2018-10-26
  • XGEVA® (denosumab): Risk of new primary malignancy 2018-10-26
  • TECENTRIQ® (Atezolizumab): Risk of nephritis 2018-10-26
  • ESMYA® (ulipristal acetate): New contraindication, restricted indication and liver function monitoring requirement 2018-10-26
  • STILNOX® 10 mg film-coated tablet (zolpidem): Restriction of indication 2018-07-30
  • ESMYA® 5 mg tablets (ulipristal acetate): Women taking Esmya® for uterine fibroids to have regular liver tests while safety review is ongoing; do not initiate treatment in new patients or those who have completed a previous treatment course 2018-04-24
  • OFEV® (nintedanib): Information on severe liver injury and the need for regular monitoring of liver function associated with the use in patients with idiopathic pulmonary fibrosis (IPF) 2018-02-22
• 2017
  • XOFIGO® (radium-223 dichloride): Important Safety Information Update Regarding Increased Incidence of Deaths and Fractures in a Randomized Clinical Trial with Xofigo® used in Combination with Abiraterone Acetate and Prednisolone/ Prednisone 2017-12-29
  • RIBOMUSTIN® (bendamustine): Increased Mortality Observed When Used in Non-approved Combination Treatments or Outside the Approved Indications; Monitor for Opportunistic Infections and Hepatitis B Reactivation 2017-10-06
  • XGEVA® (denosumab): Risk of Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation 2017-10-06
  • KEYTRUDA® (pembrolizumab): Risk of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) 2017-07-03
  • ZELBORAF® (vemurafenib): Important Drug Warning – Risk of Dupuytren’s Contracture and Plantar Fascial Fibromatosis 2017-07-03
  • DOMIDE® (thalidomide): New important advice regarding viral reactivation and pulmonary hypertension 2017-06-05
  • REVLIMID® (lenalidomide): New important advice regarding viral reactivation 2017-06-05
  • MADONNA® (levonorgestrel): Levonorgestrel-containing emergency hormonal contraception ─ New advice on interactions with hepatic enzyme inducers and contraceptive efficacy 2017-04-11
  • ESCAPELLE® & POSTINOR-2® (levonorgestrel): Levonorgestrel-containing emergency hormonal contraception ─ New advice for users of hepatic-enzyme inducers 2017-04-11
  • POMALYST® (pomalidomide): New important advice- Hepatitis B Virus status to be established before initiating treatment with pomalidomide 2017-02-28
• 2016
  • Zaltrap® (aflibercept): Information on the risk of osteonecrosis of the jaw 2016-12-30
  • Implanon NXT® (etonogestrel): Implants have been found rarely in the vasculature and lung. An update on possible risks and complications regarding insertion, localisation, removal and migration 2016-11-24
  • Invokana® (canagliflozin): Advice on the risk of lower limb amputation (primarily of the toe) during treatment with canagliflozin-containing medicines 2016-11-24
  • Tarceva® (erlotinib): First-line maintenance indication now restricted to treatment of patients whose tumours harbour an EGFR-activating mutation 2016-08-24
  • Adempas® (Riociguat): New Contraindication for Patients with Pulmonary Hypertension Associated with Idiopathic Interstitial Pneumonias (PH-IIP) 2016-08-03
  • Locabiotal® Solution (fusafungine): Withdrawal of registration following European Medicines Agency’s benefit-risk assessment 2016-06-08
  • Glivec® (imatinib) & Tasigna® (nilotinib): Risk of Hepatitis B reactivation 2016-06-08
  • Xalkori® (crizotinib): Inclusion of a new warning regarding cardiac failure 2016-06-08
  • Viekirax® (ombitasvir/ paritaprevir/ ritonavir) with or without Exviera® (dasabuvir): Not recommended in Child-Pugh B Patients 2016-06-08
  • Xgeva® 120mg & Prolia® 60mg (denosumab): Clinically Significant Cases of Hypercalcaemia after Cessation of Treatment with Denosumab in Paediatric Patients 2016-06-08
• 2015
  • Cellcept® (mycophenolate mofetil): Teratogenic risk – important new pregnancy prevention advice for women and men 2015-12-31
  • Forxiga® (dapagliflozin): Risk of Diabetic Ketoacidosis During Treatment With Sodium Glucose Co-transporter 2 (SGLT2)Inhibitor - Dapagliflozin 2015-09-04
  • Motilium® (domperidone): New recommendations to minimise cardiac risks 2015-09-04
  • Xgeva®120mg Solution for Injection (denosumab): Updated recommendations to minimise the risk of severe symptomatic hypocalcaemia (SSH) and osteonecrosis of the jaw (ONJ) 2015-03-23
  • Artrodar®50mg (diacerein): New restrictions of use to limit the risk of severe diarrhoea and effects on the liver 2015-02-12
• 2014
  • Reminyl® (galantamine hydrobromide): New Warning: Serious skin reactions (Stevens Johnson Syndrome [SJS] and acute generalised exanthematous pustulosis [AGEP]) 2014-12-31
  • Revatio® (sildenafil citrate): Safety Information regarding Revatio® tablets for the treatment of pulmonary arterial hypertension (PAH) 2014-10-21
  • Topamax® (topiramate): Updated Warnings and Precautions on Visual Field Defects 2014-10-21
  • Protaxos® (strontium ranelate): New restricted indication and contraindications for use 2014-08-27
  • Neupogen® (filgrastim) & Neulastim® (pegfilgrastim): Risk of capillary leak syndrome in patients with cancer (filgastrim & pegfilgastrim) and in healthy donors (filgastrim only) 2014-08-27
  • Gran® (filgrastim) & Peglasta® (pegfilgrastim): Risk of capillary leak syndrome in patients with cancer (filgastrim & pegfilgastrim) and in healthy donors (filgastrim only) 2014-08-19
  • Vectibix® (panitumumab): Rare cases of Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported in patients treated with Vectibix® 2014-07-15
  • Ritalin and Ritalin LA® (methylphenidate hydrochloride): New warning on priapism in patients treated for Attention Deficit Hyperactivity Disorder (ADHD) 2014-07-15
  • Dilatrend® (carvedilol): Warning on Severe Adverse Cutaneous Reactions 2014-05-30
  • Tykerb® (Lapatinib): Comparative data have shown that lapatinib based regimens are less effective than trastuzumab based regimens for metastatic breast cancer in certain settings 2014-04-30
  • Concerta® (Methylphenidate hydrochloride): New warning on priapism in patients treated for Attention Deficit Hyperactivity Disorder (ADHD) 2014-04-30
  • Zofran® (Ondansetron): Dose-dependent QT interval prolongation – updated information on posology for intravenous (IV) use in the prevention of Chemotherapy-Induced Nausea And Vomiting (CINV) 2014-04-30
  • Erbitux® (Cetuximab): Importance of establishing wild type RAS status (exons 2,3,4 of KRAS and NRAS) before treatment in metastatic colorectal cancer (mCRC) 2014-04-30
  • Ultracet® Tablet (tramadol and paracetamol): Association with Serious Skin Reactions–Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) 2014-04-30
  • Frisium® (clobazam): Update to include serious skin reactions in package insert for Malaysia 2014-04-30