VA Center For Medication Safety (VA MedSAFE) - Pharmacy Benefits Management Services
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VA Center For Medication Safety (VA MedSAFE)

Bulletins And News Alerts

Alerts are based on the clinical evidence available at the time of publication. Recommendations are intended to assist practitioners in providing consistent, safe, high quality, and cost effective drug therapy. They are not intended to interfere with clinical judgment.  When using dated material, the clinician should consider new clinical information, as available and applicable.

Safety IssueDate of ReleaseSafety Information
Dolutegravir (Juluca, Tivicay, Triumeq) and Potential Risk for Neural Tube Defects 05/31/2018 National PBM Bulletin
AMENDMENT-Accu-Chek Aviva Plus Health Network Strips Urgent Medical Device Correction 05/22/2018 National PBM Patient Level Recall Communication
Acc-Chek Aviva Plus Health Network Strips Urgent Medical Device Correction 05/18/2018 National PBM Patient Level Recall Communication
Heparin and Saline Syringe Recall Due to Contamination 05/03/2018 National PBM Patient Level Recall Communication
Synthetic Marijuana and Potential Risk for Bleeding UPDATE 04/20/2018 National PBM Bulletin
Synthetic_Marijuana_Potential_Risk_for_Bleeding_NATIONAL_PBM BULLETIN_FINAL_040518_with_disclaimer   National PBM Bulletin
Sofosbuvir/Velpatasvir (Epclusa) and Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Look-Alike/Sound-Alike Potential 01/26/2018 National PBM Bulletin
Edaravone (Radicava™) and Potential for Leaking at Valve Site 01/10/2018 National PBM Bulletin
Enoxaparin Sodium Injection: Recall Due to Incorrect Strength Syringe in Blister 12/28/2017 National PBM Patient Level Recall Communication
Calcimimetic Therapy in Patients on Dialysis: Risk of Duplicate Therapy and Safety Considerations 12/26/2017 National PBM Bulletin
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets : Recall Due to Possible Sub Potent and Super Potent Tablets 12/05/2017 National PBM Patient Level Recall Communication
Febuxostat (Uloric): FDA Evaluates Risk of Cardiovascular Death 11/21/2017 National PBM Bulletin
Afluria Pre-filled Syringe Label Creates the Potential for Confusion 11/15/2017 National PBM Bulletin
Magic3® HydroSil Gripper and Personal Intermittent Catheters: Recall for Sterile Barrier Breach 10/23/2017 National PBM Patient Level Recall Communication
Addendum - Procrit® (epoetin alfa) 1 mL Single-Dose, Preservative-Free Solution: Recall Due to Presence of Glass Particles 09/25/2017 National PBM Patient Level Recall Communication
Medtronic Recall of MiniMed Infusion Sets Due to Potential Over-Delivery of Insulin 09/18/2017 National PBM Patient Level Recall Communication
Procrit® (epoetin alfa) 1 mL Single-Dose, Preservative-Free Solution: Recall Due to Presence of Glass Particles 09/01/2017 National PBM Patient Level Recall Communication
Lorazepam Oral Concentrate, USP 2mg/mL Recall Due to Misprinted Dosing Droppers Supplied with the Product 08/23/2017 National PBM Patient Level Recall Communication
Magnesium Citrate Recall Due to Product Contamination 08/17/2017 National PBM Patient Level Recall Communication
Leader Brand, Major Pharmaceuticals, and Rugby Laboratories Recall of ALL Liquid Products Manufactured by PharmaTech Due to B. cepacia Contamination Risk 08/15/2017 National PBM Patient Level Recall Communication
Becton Dickinson - Insulin Syringes:Recall Due to Incorrect Product Labeling 06/15/2017 National PBM Patient Level Recall Communication
Apixaban (Eliquis®) Recall Due to Incorrect Strength in Bottle 06/08/2017 National PBM Patient Level Recall Communication
EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device 04/04/2017 National PBM Patient Level Recall Communication
Direct-Acting Antiviral Safety Issues 03/14/2017 National PBM Bulletin
ADDENDUM: Mirtazapine Tablets, USP 45mg – Ongoing Recall Due to Commingled Tablets 03/08/2017 National PBM Patient Level Recall Communication
Mirtazapine Tablets, USP 45mg – Recall Due to Potential of Commingled Tablets 03/07/2017 National PBM Patient Level Recall Communication
Alprostadil for Injection (Edex®) – Recall Due to Potential Lack of Sterility Assurance 03/06/2017 National PBM Patient Level Recall Communication
Chlorhexidine Gluconate Safety 02/07/2017 National PBM Bulletin
Liquid Products Recall (PharmaTech) Due to Potential Risk of Product Contamination 10/12/2016 National PBM Patient Level Recall Communication
GlucaGen® HypoKit® (Novo Nordisk Inc.) Recall Due to Needle Detachment from Syringe 09/14/2016 National PBM Patient Level Recall Communication
Eye Wash/Eye Irrigating Soutions Recall Due to Microbial Contamination 09/09/2016 National PBM Patient Level Recall Communication
Topical Skin Products Recall Due to Microbial Contamination 08/29/2016 National PBM Patient Level Recall Communication
Amikacin Recall Due to Particulate Matter in Vials 08/08/2016 National PBM Patient Level Recall Communication
Bactroban (Mupirocin) Recall Expansion 08/04/2016 National PBM Patient Level Recall Communication
Lithium Safety 07/25/2016 National PBM Bulletin
Various Diabetic Test Strips Recall (specific sites only) 07/12/2016 National PBM Patient Level Recall Communication
Contaminated Oral Liquid Docusate 06/29/2016 National PBM Patient Level Recall Communication
Fluoroquinolone Safety 06/03/2016 National PBM Bulletin
Ketoconazole Safety 05/31/2016 National PBM Bulletin
Canagliflozin and Risk of Amputations 05/31/2016 National PBM Bulletin
Antipsychotic Agents and Safety Issues 05/13/2016 National PBM Bulletin
Metformin Revised Warnings 04/18/2016 National PBM Bulletin
Thyrogen® (thyrotropin alfa for injection) Recall Due to Glass Particulates 04/01/2016 National PBM Patient Level Recall Communication
Idelalisib Safety 03/29/2016 National PBM Bulletin
Amikacin Recall Due to Glass Particulates 03/15/2016 National PBM Patient Level Recall Communication
Noxafil (Posaconazole): Dosing Errors When Switching Between Different Oral Formulations 01/13/2016 National PBM Bulletin
Bactroban (Mupirocin) Recall: ADDENDUM 12/17/2015 National PBM Patient Level Recall Communication
OmniPod Insulin Management System Recall: ADDENDUM 12/14/2015 National PBM Patient Level Recall Communication
Auvi-Q (epinephrine injection, USP) Recall - Potential Inaccurate Dosage Delivery 10/30/2015 National PBM Patient Level Recall Communication
BD Syringes and Loss of Drug Potency: FDA Expands Warning - UPDATE 09/23/2015 National PBM Bulletin
OmniPod Insulin Management System Recall 09/15/2015 National PBM Patient Level Recall Communication
Allergan Ophthalmic Product Recall Due to Particulate Matter: ADDENDUM 09/04/2015 National PBM Patient Level Recall Communication
Allergan Ophthalmic Product Recall Due to Particulate Matter 09/02/2015 National PBM Patient Level Recall Communication
BD Syringes and Loss of Drug Potency 08/31/2015 National PBM Bulletin
Adverse Cardiovascular Thrombotic Events with NSAIDs: FDA Strengthens Warning 08/04/2015 National PBM Bulletin
Ketorolac Recall Due to Particles in Glass Vial: ADDENDUM 07/02/2015 National PBM Patient Level Recall Communication
Nexium Recall Due to Bottle Containing Seroquel Instead 06/24/2015 National PBM Patient Level Recall Communication
SGLT2 Inhibitors and Potential Risk for Acidosis 05/22/2015 National PBM Bulletin
Ketorolac Recall Due to Particles in Glass Vial 05/04/2015 National PBM Patient Level Recall Communication
Ferumoxytol and Risk of Serious Allergic Reactions 04/28/2015 National PBM Bulletin
Amiodarone Use with Ledipasvir/Sofosbuvir (Harvoni) or Sofosbuvir (Sovaldi) Combined with Another Direct-Acting Antiviral and Bradycardia 03/31/2015 National PBM Bulletin
UPDATE: Testosterone Products and Cardiovascular Safety 03/26/2015 National PBM Bulletin
DAPT Trial and Risk of Non-Cardiovascular Death 12/17/2014 National PBM Bulletin
Dimethyl Fumarate (Tecfidera) and PML Resulting in Death 11/07/2014 National PBM Bulletin
Creon Recall Due to Presence of Capsule of Incorrect Strength in Bottle 10/03/2014 National PBM Communication
Digoxin in Patients with Atrial Fibrillation: Potential Harms 09/30/2014 National PBM Bulletin
UPDATE: Niacin Study Results and Implications 08/29/2014 National PBM Bulletin
Acetaminophen Safety 06/10/2014 National PBM Bulletin
Eszopiclone (Lunesta): Lowered Dose Recommendations Due to Next-Day Impairment 05/28/2014 National PBM Bulletin
Adverse Neurologic Events and Epidural Corticosteroid Injections for Pain 05/01/2014 National PBM Bulletin
Alli (orlistat) Recall Due to Product Tampering 04/04/2014 National PBM Communication
Effexor and Venlafaxine Recall for Possible Presence of Tikosyn Capsules 03/10/2014 National PBM Communication
Saxagliptin and Cardiovascular Safety 02/18/2014 National PBM Bulletin
Testosterone Products and Cardiovascular Safety 02/07/2014 National PBM Bulletin
ADDENDUM: Additional Lots Identified for Abbott Freestyle Glucose Test Strips Recall 12/04/2013 National PBM Communication
Abbott FreeStyle Glucose Test Strips Recall 11/29/2013 National PBM Communication
Regadenoson (Lexiscan) and Adenosine (Adenoscan): Risk of Heart Attack and Death 11/29/2013 National PBM Bulletin
Imitrex STATdose System and Sumatriptan Succinate Injection Refill 6mg Recall 11/22/2013 National PBM Communication
LMWHs and Increased Risk of Spinal Column Bleeding and Paralysis 11/15/2013 National PBM Bulletin
Low Molecular Weight Heparins (LMWHs) and Increased Risk of Spinal Column Bleeding and Paralysis 11/15/2013 National PBM Bulletin
Tigecycline (Tygacil) and Increased Risk of Death 10/01/2013 National PBM Bulletin
Nova Max Glucose Test Strips Recall Due To Falsely Elevated Blood Glucose Results 08/14/2013 National PBM Communication
Valproate Use During Pregnancy and Lower IQ in Children Exposed 08/06/2013 National PBM Bulletin
Medtronic Recall of Reservoirs Used with Paradigm Insulin Pumps Due to Leaks 07/23/2013 National PBM Communication
Hydoxyethyl Starch Solutions and Mortality and Acute Kidney Injury 07/19/2013 National PBM Bulletin
Aspirin Lot Recalled for Containing Acetaminophen Instead 07/01/2013 National PBM Communication
Prevnar 13 and Pneumovax 23: Medication Errors and Appropriate Use 04/10/2013 National PBM Bulletin
Sodium Phosphate Enema and Fatal Outcome 03/26/2013 National PBM Bulletin
Peginesatide Injection Recall and Anaphylaxis

03/04/2013

National PBM Communication
Dual Renin-Angiotensin Aldosterone System Blockade and Impaired Renal Function and Hyperkalemia 02/12/2013 National PBM Bulletin
Rugby Ferrous Sulfate Recall Due to Bottle Improperly Containing Meclizine HCL 25 mg Tablets 01/13/2013 National PBM Communication
Zolpidem and Proposed Lower Doses Due to Impaired Mental Alertness 01/16/2013 National PBM Communication
Ondansetron 32mg Single IV Dose Market Withdrawal Due to Cardiac Risks 12/05/2012 National PBM Bulletin
Dabigatran (Pradaxa®) and Packaging Error - Recall Due to Possible Compromise in Product Quality 11/09/2012 National PBM Communication
Ameridose Recall of All Unexpired Product Line 11/01/2012 National PBM Communication
ADDENDUM: Fungal Meningitis Outbreak and Additional Patient Notification 10/18/2012 National PBM Communication
Compounded Epidural Steroid Injections and Meningitis Outbreak 10/05/2012 National PBM Communication
Citalopram (Celexa®) and Dose-Dependent QT Interval Prolongation: UPDATED RECOMMENDATIONS 04/17/2012 National PBM Bulletin
Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol Tablets - Recall for Inexact Tablet Counts or Out of Sequence Tablets 02/03/2012 National PBM Communication
Aliskiren: Adverse Drug Events When Concomitantly Used with ACE Inhibitors or ARBs in Patients with Type II DM 01/13/2012 National PBM Bulletin
Dronedarone and Cardiovascular Events in Permanent Atrial Fibrillation 01/10/2012 National PBM Communication
Lexiscan® (Regadenoson) Update: New Safety Labeling Changes Approved By FDA 11/15/2011 National PBM Communication
Target Dose of Angiotensin II Receptor Antagonists in Patients with Heart Failure 10/31/2011 National PBM Communication
Citalopram Hydrobromide (Celexa®) and Dose-Dependent QT Interval Prolongation: UPDATE 09/29/2011 National PBM Bulletin
Oral Contraceptives and Packaging Error Recall 09/21/2011 National PBM Communication
Erythropoiesis-Stimulating Agents (ESAs) in Chronic Kidney Disease (CKD) and New Dosing Recommendations 08/09/2011 National PBM Communication
Dronedarone (Multaq®) and Risk of Death and Serious CV Events in Patients with Permanent AF 07/28/2011 National PBM Communication
Colistimethate for Injection and Dosing Confusion 07/08/2011 National PBM Bulletin
Recall of Butalbital, APAP, and Caffeine Tablets and Hydrocodone Bitartrate and APAP Tablets – Mislabeling 06/30/2011 National PBM Communication
Churchill Medical Skin-Prep Wipes Recall Due to Bacterial Contamination 06/17/2011 National PBM Communication
SimplyThick Thickening Gel Products Recall and Possible Presence of Bacteria 06/10/2011 National PBM Communication
Simvastatin: Updated Restrictions, Contraindications and Dose Limitations 06/09/2011 National PBM Bulletin
ADDENDUM: Warfarin and High PotencyEXPANDED Recall 06/02/2011 National PBM Communication
ADDENDUM: Smith & Nephew Various Adhesive Remover Wipes and Potential ContaminationRECALL 05/31/2011 National PBM Communication
Nitroglycerin Tablets and Packaging Error Recall 05/25/2011 National PBM Communication
Smith & Nephew Various Adhesive Remover Wipes and Potential Contamination RECALL 05/20/2011 National PBM Communication
Marcaine Incorrect Labeling and Potential Look-Alike Confusion 05/13/2011 National PBM Bulletin
Warfarin and High Potency Recall 05/12/2011 National PBM Communication
Citalopram and Finasteride Recall Due to Mislabeling 03/31/2011 National PBM Communication
Povidine® Iodine Prep Pads and Potential Microbial Contamination Recall 03/29/2011 National PBM Communication
Dexamethasone Sodium Phosphate Inj USP 4mg/ml and Particulate Formation Recall 03/23/2011 National PBM Communication
PPIs: Long-Term Use and Risk of Hypomagnesemia 03/11/2011 National PBM Communication
Dicyclomine and Doxycycline LASA Confusion 03/10/2011 National PBM Bulletin
Maternal and Newborn Risks with Certain Medications Used During Pregnancy 03/09/2011 National PBM Communication
Albuterol Sulfate Inhalation Solution Recall- Packaging Error 02/11/2011 National PBM Communication
Dronedaraone and Liver Injury 01/27/2011 National PBM Communication
Triad Group Recall – Sterile Lubricating Jelly and Alcohol Swabs 01/20/2011 National PBM Communication
Abbott Glucose Test Strips Recall 12/28/2010 National PBM Communication
Propoxyphene and Cardiac Toxicity 11/19/2010 National PBM Bulletin
Dronedaraone and Adverse Events Reported in ISMP 11/15/2010 National PBM Communication
Epoetin Alfa (Epogen and Procrit) Voluntary Recall 09/28/2010 National PBM Communication
Regadenoson (Lexiscan) and Updated Labeling 09/22/2010 National PBM Communication
New Considerations for the Safe and Effective Use of Colchicine 07/15/2010 National PBM Bulletin
Heparin and Potency Variation: UPDATE 04/07/2010 National PBM Communication
Clopidogrel and Boxed Warning Regarding Poor Metabolizers 03/25/2010 National PBM Bulletin
LABA Safety in Asthmatic Patients 03/09/2010 National PBM Communication
Clopidogrel and Omeprazole Drug Interaction 02/12/2010 National PBM Bulletin
Natalizumab and the Risk for Developing PML and IRIS 02/09/2010 National PBM Bulletin
Sirolimus Monitoring 01/22/2010 National PBM Bulletin
Safety of High Dose Statin-Fibrate Combinations 11/10/2009 National PBM Bulletin
Influenza Vaccine Adverse Event Reporting 10/19/2009 National PBM Bulletin
Heparin and Potency Variation 10/02/2009 National PBM Communication
Sitagliptin and Acute Pancreatitis 09/29/2009 National PBM Communication
Vitamin D: High Dose Use and Safety 09/15/2009 National PBM Bulletin
Fentanyl Transdermal System Recall Due to Leaking Contents 08/20/2009 National PBM Communication
Dextroamphetamine/Amphetamine 20mg Tablet recall Due to Weight Variability 08/20/2009 National PBM Communication
Risk of Severe Hypoglycemia with Glyburide Use in Elderly Patients with Renal Insufficiency 07/29/2009 National PBM Bulletin
Propofol and Urgent Drug Recall by Teva Due to Contaminated Lots 07/14/2009 National PBM Communication
Medtronic and Quick-Set Infusion Sets Recall 07/13/2009 National PBM Communication
Varenicline and Bupropion and Neuropsychiatric Adverse Events 07/02/2009 National PBM Communication
Oxybutynin and Oxycodone and LASA Confusion 07/02/2009 National PBM Bulletin
Citalopram and Tablet Size Variance Recall 06/30/2009 National PBM Communication
Tacrine and Tacrolimus LASA Confusion 06/25/2009 National PBM Bulletin
Leukotriene Inhibitors and Neuropsychiatric Adverse Events 06/15/2009 National PBM Communication
TNF-a Blockers, including Simponi [golimumab], and Risk of Fungal Infections 05/27/2009 FDA MedWatch Safety Alert
Macrodantin and Macrobid LASA Confusion 05/06/2009 National PBM Bulletin
Regadenoson (Lexiscan) and Updated Labelling 05/05/2009 National PBM Communication
Clevidipine and Propofol Potential Look-Alike Confusion 04/30/2009 National PBM Communication
Ceftriaxone (Rocephin) and Calcium Interaction 04/29/2009 National PBM Communication
Digoxin and Tablet Size Variability Recall 04/02/2009 National PBM Communication
Infed (Iron Dextran) and Precipitate Formation Recall 04/02/2009 National PBM Communication
Propafenone HCL 225mg (Watson) and Variability in Active Ingredient Recall 03/30/2009 FDA Recall - Firm Press Release
Transdermal Patches Containing Metal and Risk of Burns 03/05/2009 FDA Public Health Advisory
Rapitiva (Efalizumab) and PML 03/03/2009 National PBM Communication
Metoclopramide and Risk of Tardive Dyskinesia 02/26/2009 FDA News
Zonisamide (marketed as Zonegran, and generics) and Possible Metabolic Acidosis 02/23/2009 FDA Information for Healthcare Professionals
Clopidogrel and Alteration of Effectiveness Due to CYP219 Inhibition 01/29/2009 National PBM Communication
Duragesic Patch (50mcg/hr) and Cut in Drug Reservoir Recall 12/31/2008 Johnson and Johnson News
Visicol and Osmoprep and Acute Phosphate Nephropathy 12/19/2008 National PBM Communication
Methadone QTc Prolongation and Torsades de Pointes 12/17/2008 National PBM Communication
LIFESCAN OneTouch SureStep Test Strips and Inaccurate Readings – RECALL 12/04/2008 National PBM Communication
Phenytoin and Fosphenytoin and Serious Skin Reactions 12/03/2008 National PBM Communication
Erlotinib (Tarceva) and Hepatic Impairment 12/01/2008 National PBM Communication
ETHEX Recall 11/14/2008 National PBM Communication
ETHEX Propafenone Recall Patient Letter 11/12/2008 National PBM Communication
ETHEX Recall 11/12/2008 National PBM Communication
Concentrated Opioid Solutions and Concentration Confusion 11/12/2008 National PBM Bulletin
Natalizumab and PML 10/31/2008 National PBM Communication
Varenicline and Increase in Reports of Serious Adverse Events 10/28/2008 National PBM Communication
Iron Dextran and the Adverse Drug Events Associated with the High Molecular Weight Formulation 10/21/2008 National PBM Bulletin
Calcium and Vitamin D and Change in Formulation 10/06/2008 National PBM Bulletin
Look-Alike Error with Acetic Acid and Sterile Water Irrigation 10/02/2008 National PBM Bulletin
Rituximab and PML 9/19/2008 National PBM Communication
TNF Inhibitors and the Risk for Invasive Fungal Infections 09/05/2008 National PBM Bulletin
EPOGEN® and Amgen Announcing Nationwide Voluntary Recall 08/28/2008 Patient Letter
EPOGEN® and Amgen Announcing Nationwide Voluntary Recall 08/28/2008 National PBM Communication
Natalizumab and PML 08/27/2008 National PBM Communication
Ezetimibe/Simvastatin (Vytorin®), Simvastatin, and Ezetimibe (Zetia®) and Risk for Cancer 08/26/2008 National PBM Communication
Naltrexone Injection Site Reactions 08/20/2008 National PBM Alert
Exenatide (Byetta) and Hemorrhagic and Necrotizing Pancreatitis 08/19/2008 National PBM Response
Simvastatin and Amiodarone Drug-Drug Interaction 8/18/2008 National PBM Response
Mitoxantrone and Recommendations for Increased Monitoring 8/18/2008 National PBM Response
PROCRIT® (EPOETIN ALFA) LOT NUMBER P114942A and Nationwide Voluntary Recall of Ortho Biotech 8/8/2008 National PBM Response
PROCRIT® (EPOETIN ALFA) LOT NUMBER P114942A and Nationwide Voluntary Recall of Ortho Biotech – Patient Letter 8/8/2008 Patient Letter
Erythropoiesis Stimulating Agents (ESAs ): FDA Labeling Changes for Cancer Patients Receiving Myelosuppressive Chemotherapy 8/8/2008 National PBM Update Alert
Topical Thrombin and Safety Issues if Used Intravascularly 8/7/2008 National PBM Alert
Bevacizumab Plus Sunitinib and Potential for Developing Microangiopathic Hemolytic Anemia 7/31/2008 National PBM Alert
Micro-Bubble Contrast Agents (Definity® [Perflutren Lipid Microsphere] Injectable Suspension and Optison® [Perflutren Protein-Type A Microspheres] for Injection): Risk of Cardiopulmonary Reactions and Changes to Package Labeling 7/18/2008 National PBM Alert
Nationwide Recall of Sodium Polystyrene Sulfonate Suspension, USP (15g/60ml) (NDC 0054-0165-51; Lot 856396A Expiration April 2010, and Lot 856693A ExpirationMay 2010) 7/17/2008 National PBM Alert
Nationwide Recall of Sodium Polystyrene Sulfonate Suspension, USP (15g/60ml) (NDC 0054-0165-51; Lot 856396A Expiration April 2010, and Lot 856693A ExpirationMay 2010) 7/17/2008 Patient Letter
Fluoroquinolone Use and the Potential for Tendinitis and Tendon Rupture 7/10/2008 National PBM Bulletin
CellCept® (mycophenolate mofetil) and Cases of Progressive Multifocal Leukoencephalopathy (PML) 7/1/2008 National PBM Bulletin
Varenicline (marketed as Chantix) and Recent Safety Issues 6/20/2008 Patient Letter (VA Secretary)
Antipsychotic Use and Increase Risk of Death in Patients with Dementia-Related Psychosis 6/16/2008 FDA Information for Healthcare Professionals
Becaplermin (Regranex) Safety Information and Labeling Changes 6/11/2008 National PBM Bulletin
Tumor Necrosis Factor (TNF) Antagonists and the Development of Lymphomas and Other Cancers in Children and Young Adults (< 18 years) 6/4/2008 FDA Early Communication
Varenicline (marketed as Chantix) and Recent Safety Issues 5/30/2008 National PBM Bulletin Addendum
Varenicline (marketed as Chantix) and Recent Safety Issues 5/30/2008 VA Patient Letter
Aprotinin (Trasylol®) and Increased Risk of Death and Other Serious Adverse Events – Temporary Suspension in Marketing 5/16/2008 National PBM Bulletin
Use of Abacavir or Didanosine and Higher Risk of Heart Attack 4/4/2008 National HIV/AIDS Program Commentary
Heparin Manufacturer Recalls 4/2/2008 B. Braun Internal Distribution Letter
Heparin Manufacturer Recalls 3/28/2008 FDA Firm Press Release – Covidien Voluntary recall of Heparin Pre-Filled Syringes
Use of Abacavir or Didanosine and Higher Risk of Heart Attack 3/27/2008 FDA Early Communication
Heparin Manufacturer Recalls 3/27/2008 Advanced Medical Internal Distribution Letter
Heparin Manufacturer Recalls 3/21/2008 Advanced Medical Manufacturer Letter
Heparin Manufacturer Recalls 3/25/2008 Advanced Medical Important Notice
Heparin Manufacturer Recalls 3/21/2008 FDA Firm Press Release for B.Braun Medical, Inc.
Heparin Manufacturer Recalls 3/20/2008 B.Braun Urgent Drug Recall
Update: Baxter Heparin Sodium Recall – Alternatives to Heparin Sodium 3/19/2008 Update
Etanercept and Tuberculosis and Infections 3/14/2008 Dear Healthcare Professional Letter (Amgen)
EPOGEN®/PROCRIT® and Aranesp® and Additional Trials Showing Increased Mortality and/or Tumor Progression 3/7/2008 Dear Healthcare Professional Letter (Amgen)
Update: Baxter Heparin Sodium Recall 3/3/2008 Update B. Braun – April 2008
Calcium Supplements and Cardiovascular Disease in Older Women 3/1/2008 Review of a recent BMJ Article
Baxter - Allergic Reactions to Heparin Sodium 2/19/2008 National PBM Bulletin
Antiepileptic Drugs and Suicidality 2/11/2008 National PBM Bulletin
Temsirolimus (Torisel®) Final Dose Concentration 2/7/2008 National PBM Bulletin Addendum
Temsirolimus (Torisel®) Final Dose Concentration 1/22/2008 National PBM Bulletin
Haloperidol and Cyanocobalamin 1ML Vials – Look-Alike Safety Alert 12/20/2007 National PBM Bulletin
IV Haloperidol and Torsades de Pointe 11/28/2007 Updated Labeling
Myfortic® (mycophenolic acid) and Increased Risks of Pregnancy Loss and Congenital Malformations / Change from Pregnancy Category C to Pregnancy Category D 11/27/2007 Dear Healthcare Professional Letter (Novartis)
Varenicline (marketed as Chantix) and Suicidal Thoughts and Aggressive or Erratic Behavior 11/20/2007 FDA Early Communication
Varenicline (marketed as Chantix) and Suicidal Thoughts and Aggressive or Erratic Behavior 11/20/2007 FDA Patient Information Sheet
Varenicline (marketed as Chantix) and Suicidal Thoughts and Aggressive or Erratic Behavior 11/20/2007 PBM Update: Varenicline Safety
Rosiglitazone and Increased Risk of Myocardial Ischemia 11/19/2007 FDA Information for Healthcare Professionals
Erythropoiesis Stimulating Agents Safety Alert 11/15/2007 National PBM Bulletin Addendum
Sildenafil (marketed as Viagra and Revatio) Vardenafil (marketed as Levitra) Tadalafil (marketed as Cialis) and Hearing Loss 11/14/2007 FDA Information for Healthcare Professionals
Cefipime (marketed as Maxipime) and Increased Mortality 11/14/2007 FDA Early Communication
Aprotinin (Trasylol®) and Increased Risk of Death and Other Serious Adverse Events – Temporary Suspension in Marketing 11/6/2007 National PBM Bulletin
Codeine Use in Breast-Feeding Women 10/9/2007 National PBM Bulletin
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE 9/28/2007 National PBM Bulletin
IV Haloperidol and Torsades de Pointe 9/17/2007 FDA MedWatch Summary
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE 9/11/2007 FDA Alert
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE 9/11/2007 Information for Healthcare Professionals (FDA)
Viracept (nelfinavir mesylate) and presence of ethyl methanesulfonate (EMS), a process-related impurity 9/10/2007 FDA Drug Safety Information
Entecavir (Baraclude® ) and potential for the development of HIV (human immunodeficiency virus) resistance in HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) 8/16/2007 Dear Healthcare Professional Letter (Bristol-Myers Squibb)
Rosiglitazone and Risk of Heart Failure 8/14/2007 FDA Information for Healthcare Professionals
Pioglitazone and Risk of Heart Failure 8/14/2007 FDA Information for Healthcare Professionals
Omeprazole (Prilosec®) and Esomeprazole (Nexium®) and Cardiovascular Events 8/9/2007 Early Communication about an Ongoing Safety Review
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE 8/1/2007 Dear Healthcare Professional Letter (Roche)
Omalizumab (Xolair®) and Anaphylactic Reactions 7/10/2007 National PBM Bulletin
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products 7/5/2007 FDA Alert
Trimetrexate Glucuronate (Neutrexin®) and Drug Discontinuation 3/16/2007 Dear Healthcare Professional Letter
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products 6/1/2007 Dear Healthcare Professional Letter
Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance) and Risk for Nephrogenic Systemic Fibrosis 5/23/2007 FDA Alert
Rosiglitazone (Avandia®) and Cardiovascular Events 5/22/2007 Information for Healthcare Professionals
Rosiglitazone (Avandia®) and Cardiovascular Events 5/21/2007 FDA Alert
Rosiglitazone (Avandia®) and Cardiovascular Events 5/21/2007 FDA News
Pergolide (Permax®) and Heart Valve Damage 5/14/2007 National PBM Bulletin
Antidepressant Medications and New Warnings About Suicidal Thinking, Behavior in Young Adults 5/2/2007 FDA Press Release
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE 5/1/2007 Prescribing Information (Roche)
Zolpidem (Ambien®) High Dose Use and Dose-Related Adverse Events 5/1/2007 Review of Various Trials Using Zolpidem at Higher Doses
Look-Alike Sound-Alike Confusion Potential with Humapen Memoir® and Humira® Pen 4/5/2007 Humira Pen and HumaPen; ISMP Newsletter
Tegaserod and Discontinued Marketing for Safety Reasons 4/3/2007 National PBM Bulletin
Methadone (Dolophine®) and Serious Side Effects 4/1/2007 Methadone Related Deaths; PBM Ez Minutes April-June 2007
Pergolide (Permax®) and Heart Valve Damage 3/29/2007 FDA Public Health Advisory
Lamivudine and Zidovudine (Combivir®) Tablets and Counterfeit Labeling 3/28/2007 Dear Pharmacy Professional Letter
Linezolid (Zyvox®) and Increased Mortality 3/16/2007 FDA Alert
Linezolid (Zyvox®) and Increased Mortality 3/16/2007 Healthcare Professional Sheet
Telithromycin (Ketek®) and Safety Issues 3/1/2007 Dear Healthcare Professional Letter
Omalizumab (Xolair®) and Anaphylactic Reactions 2/21/2007 FDA Alert
Omalizumab (Xolair®) and Anaphylactic Reactions 2/21/2007 FDA News
Omalizumab (Xolair®) and Anaphylactic Reactions 2/21/2007 Healthcare Professional Sheet
Telithromycin (Ketek®) and Serious Liver Toxicity 2/12/2007 FDA News – Label and Indication Changes
Telithromycin (Ketek®) and Serious Liver Toxicity 2/12/2007 Questions and Answers on Telithromycin
Quinine and Unapproved Use for Leg Cramps Due to Serious Side Effects 2/8/2007 National PBM Bulletin
IV Promethazine (Phenergan®) and Tissue Injury 2/1/2007 A Guidance on IV Promethazine Use and Safety Issues
Erythropoiesis Stimulating Agents Safety Alert 1/9/2007 National PBM Bulletin
Erythropoiesis Stimulating Agents Safety Alert 1/9/2007 Safety Concerns of Erythropoiesis Stimulating Agents
Look-Alike Sound-Alike Confusion Potential with Humapen Memoir® and Humira® Pen 1/1/2007 Two Pens Different Uses; PBM Ez-Minutes January-March 2007
Quinine and Unapproved Use for Leg Cramps Due to Serious Side Effects 1/1/2007 Quinine Not for Leg Cramps Anymore; PBM Ez-Minutes January-March 2007
Rituximab (Rituxan®) and Progressive Multifocal Leukoencephalopathy 12/18/2006 FDA Alert
Rituximab (Rituxan®) and Progressive Multifocal Leukoencephalopathy 12/18/2006 FDA Information for Healthcare Professionals
Quinine and Unapproved Use for Leg Cramps Due to Serious Side Effects 12/11/2006 FDA News
Quinine and Unapproved Use for Leg Cramps Due to Serious Side Effects 12/11/2006 FDA Questions and Answers on Unapproved Quinine Products
Methadone (Dolophine®) and Serious Side Effects 11/30/2006 National PBM Bulletin
Methadone (Dolophine®) and Serious Side Effects 11/30/2006 VAMedSAFE Bulletin
Methadone (Dolophine®) and Serious Side Effects 11/27/2006 FDA Alert
Methadone (Dolophine®) and Serious Side Effects 11/27/2006 Healthcare Provider Information
Oseltamivir Phosphate (Tamiflu®) and Precaution for Neuropsychiatric Events 11/13/2006 Dear Healthcare Professional Letter
Fluarix® and Twinrix® Look-Alike Confusion Potential 11/1/2006 National PBM Bulletin
Bevacizumab 10/1/2006 National PBM Bulletin
Look-Alike Sound-Alike Vaccine Mix-ups: Adacel (Tdap) and Daptacel (DTaP) 8/24/2006 ISMP Newsletter
IV Promethazine (Phenergan®) and Tissue Injury 8/10/2006 ISMP Newsletter
Telithromycin (Ketek®) and Serious Liver Toxicity 7/5/2006 Questions and Answers on Telithromycin
Telithromycin (Ketek®) and Serious Liver Toxicity 6/29/2006 FDA News for New Product Labeling Regarding Safety Issues
Benzocaine 2/28/2006 A Guidance on the Use of topical Anesthetics for Naso/Oropharyngeal and Laryngotracheal Procedures
Benzocaine 2/10/2006 FDA Public Health Advisory
Benzocaine 2/8/2006 NCPS Patient Safety Alert
Telithromycin (Ketek®) and Serious Liver Toxicity 1/20/2006 FDA Public Health Advisory
Telithromycin (Ketek®) and Serious Liver Toxicity 1/20/2006 Questions and Answers on Telithromycin
Benzocaine 10/1/2005 VAMedSAFE Patient Safety Issues – Benzocaine (Hurricaine Spray); PBM Ez-Minutes October-December 2005
Phosphodiesterase 5 Inhibitors and Loss of Vision 8/5/2005 National PBM Bulletin
Clinical Guidance on Replacement Product Recommendations for Avandamet and Paxil CR in the VA 3/29/2005 National PBM Bulletin
Vitamin E 1/13/2005 National PBM Bulletin
Ethyl Chloride Safety Awareness 1/1/2005 Ethyl Chloride Ignites; PBM Ez-Minutes January-March 2005
Fentanyl Transdermal Patch 12/22/2004 National PBM Bulletin
HIV Agents New on Formulary 12/21/2004 National PBM Bulletin
Vitamin E 12/1/2004 VAMedSAFE Bulletin
Vitamin E 12/1/2004 Background: High Dose Vitamin E (> 400IU/Day)
Statins 9/1/2004 Statin-Fibrate Report – Focus on Safety
Rofecoxib 7/21/2004 National PBM Bulletin
Statins 12/1/2001 Recommendations for the Use of 3-Hydroxy-3-methylglutaryl Coenzyme A Reductase Inhibitors (statins) in Veteran Patients Receiving Medications with the Potential for Drug-Drug Interactions
Oxycontin – Diversion and Abuse 12/1/2001

VA Office of Inspector General Pharmaceutical Bulletin