REAKSI Drug Safety News (Berita Keselamatan Ubat REAKSI)

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Note: From 2018 onwards, there will be no new publications of the REAKSI Newsletter. For the most recent safety issues regarding medicine use, please refer to Safety Alerts for Healthcare Professionals.



List of REAKSI Newsletter (click on the issue to download)

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Reaksi Drug Safety News 2017 - Issue 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)

Reaksi Drug Safety News 2017 - Issue 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

Reaksi Drug Safety News 2017 - Issue 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)

Reaksi Drug Safety News 2017 - Issue 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 January 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 July 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 May 2016

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

REAKSI March 2016

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

REAKSI January 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 July 2015

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

REAKSI May 2015

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

REAKSI March 2015

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

REAKSI January 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 July 2014

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

REAKSI May 2014

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

REAKSI March 2014

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

REAKSI January 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 July 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 May 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 March 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 January 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 July 2012

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

Reaksi May 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 March 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 January 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 July 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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