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