Berita Keselamatan Ubat REAKSI

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Nota: Mulai Tahun 2018, tiada penerbitan baru untuk Reaksi Newsletter. Untuk maklumat keselamatan ubat, sila rujuk kepada Safety Alerts for Healthcare Professionals


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Carian mengikut tarikh penerbitan, isu keselamatan ubat, nama produk, bahan aktif farmaseutikal, dan sebagainya. 



 Berita Reaksi 2017 - Edisi 6/2017

  • Ketamine: Risk of Severe Liver Damage with Repeated and/or Prolonged Use at High Doses
  • Recombinant Human Erythropoietins: Risk of Severe Cutaneous Adverse Reactions (SCARs)

 Berita Reaksi 2017 - Edisi 5/2017

  • Vemurafenib: Risk of Dupuytren’s Contracture and Plantar Fascial Fibromatosis
  • Leflunomide and Teriflunomide: Risk of Falsely Decreased Ionised Calcium Levels and Risk of Colitis

 Berita Reaksi 2017 - Edisi 4/2017

  • Hyoscine Butylbromide Injection: Risk of Serious Adverse Effects in Patients with Underlying Cardiac Disease
  • Keytruda® (pembrolizumab): Risk of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

Berita Reaksi 2017 - Edisi 3/2017

  • Loperamide: Risk of Serious Cardiac Adverse Events with High Doses, Including Through Misuse
  • Thalidomide, Lenalidomide and Pomalidomide: Risk of Hepatitis B Reactivation, Herpes Zoster and Pulmonary Hypertension

 REAKSI March 2017

  • Interferon alfa & Interferon beta: Risk of Pulmonary Arterial Hypertension
  • Fluconazole: Caution in Use During Pregnancy

 REAKSI Januari 2017

  • Eylea ® vs. Zaltrap ® (aflibercept):Same Active Ingredient,Different Safety Profiles?

REAKSI November 2016

  • Infliximab: Risk of Cervical Cancer
  • Implanon NXT® (etonogestrel implant): Reports of Implants Found in the Vasculature and Lung

 REAKSI September 2016

  • Live Attenuated Vaccines: Reminder to Avoid Use In Immunosuppressed Individuals

 REAKSI Julai 2016

  • Concomitant Use of Spironolactone and Renin-Angiotensin System Drugs in Heart Failure: Risk of Potentially Fatal Hyperkalaemia
  • Noxafil® (posaconazole): Tablet and Oral Suspension Not Interchangeable

 REAKSI Mei 2016

  • Apomorphine with Domperidone: Minimising the Risk of Cardiac Side Effects
  • Locabiotal® Solution (fusafungine): Withdrawal of Registration and Product Recall

 REAKSI Mac 2016

  • Proton Pump Inhibitors (PPIs): Potential Long-term Safety Issues
  • Paliperidone Palmitate (Invega Sustenna®): Alert on Potential Serious Adverse Events

 REAKSI Januari 2016

  • Epoetin-associated Pure Red Cell Aplasia (PRCA): Current Scenario in Malaysia

 REAKSI November 2015

  • Testosterone Products: Possible Increased Risk of Heart Attack and Stroke
  • Ivabradine: Risk of Cardiovascular Adverse Events

 REAKSI September 2015

  • Hydroxyzine: Risk of Effects on Heart Rhythm
  • Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors: Possible Risk of Diabetic Ketoacidosis

REAKSI Julai 2015

  • Patent Ductus Arteriosus (PDA) Closure: Indomethacin vs. Ibuprofen – An Overview of the Local Drug Safety Profiles

REAKSI Mei 2015

  • Bromocriptine: Not to be used routinely for lactation suppression
  • Febuxostat: International Reports of Agranulocytosis and DRESS

REAKSI Mac 2015

  • New Alerts on Serious Skin Reactions
  • Chlorhexidine Solutions: Risk of Chemical Burns to Skin in Premature Infants

REAKSI Januari 2015

  • Revatio® (sildenafil): Safety Information on Paediatric Use for Pulmonary Arterial Hypertension

REAKSI November 2014

  • Zofran® (ondansetron), Kytril® (granisetron) and Aloxi® (palonosetron): 5-HT3 Receptor Antagonist-associated Serotonin Syndrome

REAKSI September 2014

  • Methylphenidate: Risk of Priapism
  • Filgrastim and Pegfilgrastim: Risk of Capillary Leak Syndrome

REAKSI Julai 2014

  • Risperidone and Paliperidone: Risk of Intraoperative Floppy Iris Syndrome
  • Temozolomide: Risk of Hepatotoxicity
  • MencevaxACWY® Vaccine: New Data on Antibody Persistence

REAKSI Mei 2014

  • Sodium Phosphate Oral Solutions and Enemas: Possible Harm Associated With Overdose

REAKSI Mac 2014

  • Pure Red Cell Aplasia (PRCA) related to use of Erythropoietin Stimulating Agents

REAKSI Januari 2014

  • Comparison and updates on New Oral Anticoagulants (NOACs):
    • Dabigatran etexilate (Pradaxa®)
    • Rivaroxaban (Xarelto®)
    • Apixaban (Eliquis®)

REAKSI November 2013

  • Tygacil® (tigecycline): Reminder on the Increased Risk of Death
  • Lariam® (mefloquine): Visual Disturbances Including Optic Neuropathy

Reaksi September 2013

  • Montelukast: Reminder on the Neuropsychiatric Risks
  • Roflumilast: Risk of Suicidal Behaviour

Reaksi Julai 2013

  • Sodium Valproate: Risk of Decreased IQ Scores in Children After Fetal Exposure
  • Codeine Use in Children: Rare but Life-threatening Adverse Events or Death after Tonsillectomy and/or Adenoidectomy

 Reaksi Mei 2013 

  • Zithromax/ Zmax (azithromycin): Risk of potentially fatal irregular heart rhythms
  • Botulinum Toxin Products: Rare but serious risk of distant toxin spread and non-interchangeability of products

Reaksi Mac 2013

  • Prolia and Xgeva (denosumab): Associated with risk of anaphylactic reactions and atypical femoral fracture
  • Invirase (saquinavir): Removal of paediatric dosing recommendation due to potential for QT and PR interval prolongation

Reaksi Januari 2013

  • Pradaxa (dabigatran): New Contraindication in patients with prosthetic heart valve replacement
  • MabThera (rituximab)- associated Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome
  • Tredaptive/ Pelzont/ Trevaclyn (nicotinic acid/ laropiprant): Suspension of dyslipidaemia drug in the European Union

Reaksi November 2012

  • Pradaxa® (dabigatran etexilate): Not Recommended in Patients with Prosthetic Heart Valves
  • Gilenya® (fingolimod hydrochloride): Risk of Cardiovascular Events
  • Victrelis® (boceprevir): Drug Interactions With Ritonavir-boosted HIV Protease Inhibitors

Reaksi September 2012

  • Volibris® (ambrisentan): Contraindication in Patients with Idiopathic Pulmonary Fibrosis (IPF)
  • Prolia® (denosumab): Risk of Atypical Femoral Fracture
  • Case Report: Zometa® (zoledronic acid) Associated Osteomyelitis

Reaksi Julai 2012

  • Velcade® (Bortezomib): Fatal Cases Due To Erroneous Intrathecal Administration
  • Bondronat® (Ibandronic Acid): Association With Anaphylactic Reaction
  • Case Report: Amiodarone Associated Thyroid Dysfunction

Reaksi Mei 2012

  • Finasteride:
    • Sexual Dysfunction that Continued After Treatment Discontinuation
    • Suspected ADR on Sexual Dysfunction: 2 case reports
    • Potential Rare Risk of Breast Cancer in Men

Reaksi Mac 2012

  • Clostridium difficile - Associated Diarrhoea (CDAD) may be linked to Proton Pump Inhibitors (PPIs)
  • Association of Domperidone Maleate with Serious Ventricular Arrhythmia and Sudden Cardiac Death
  • Malathion: 2 ADR case reports

Reaksi Januari 2012

  • Avastin® (bevacizumab): Severe Infectious Endophthalmitis Leading to Blindness Following Unapproved Intravitreal Injection
  • Saphris® (asenapine maleate): Potential Risk of Serious Allergic Reactions
  • Xigris® [drotrecogin alfa (activated)]: Voluntary Market Withdrawal due to Failure to Show Survival Benefit

Reaksi September 2011

  • Ketoconazole: Suspension of Marketing Authorisation in France Due to Risk of Severe Hepatotoxicity
  • Champix® (Varenicline): Potential Risk of Certain Cardiovascular Events In Patients with Cardiovascular Disease
  • Zyvox (Linezolid) & Methylene Blue: Serious Central Nervous System Reactions Possible When Given to Patients Taking Certain Psychiatric Medications

Reaksi Julai 2011

  • Drospirenone-containing oral contraceptives (OC): Possible increased risk of venous thromboembolism
  • Pioglitazone: Suspension in France due to increased risk of bladder cancer
  • Rituximab: Fatal infusion-related reactions in rheumatoid arthritis



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Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

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