United States Department of Veterans Affairs






VA Center for Medication Safety - A Patient Safety Center for Inquiry

BULLETINS AND NEWS ALERTS

Safety Issue

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Date

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Safety Information
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 Communication
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
Citalopram Hydrobromide (Celexa®) and Dose-Dependent QT Interval Prolongation 08/31/2011 National PBM Bulletin
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 Potency_EXPANDED Recall 06/02/2011 National PBM Communication
ADDENDUM: Smith & Nephew Various Adhesive Remover Wipes and Potential Contamination_RECALL 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 Recall04/02/2009 National PBM Communication
Propafenone HCL 225mg (Watson) and Variability in Active Ingredient Recall03/30/2009 FDA Recall – Firm Press Release
Transdermal Patches Containing Metal and Risk of Burns03/05/2009 FDA Public Health Advisory
Rapitiva (Efalizumab) and PML03/03/2009 National PBM Communication
Metoclopramide and Risk of Tardive Dyskinesia02/26/2009 FDA News
Zonisamide (marketed as Zonegran, and generics) and Possible Metabolic Acidosis02/23/2009 FDA Information for Healthcare Professionals
Clopidogrel and Alteration of Effectiveness Due to CYP219 Inhibition01/29/2009 National PBM Communication
Duragesic Patch (50mcg/hr) and Cut in Drug Reservoir Recall12/31/2008 Johnson and Johnson News
Visicol and Osmoprep and Acute Phosphate Nephropathy 12/19/2008 National PBM Communication
Methadone QTc Prolongation and Torsades de Pointes12/17/2008 National PBM Communication
LIFESCAN OneTouch SureStep Test Strips and Inaccurate Readings – RECALL12/04/2008National PBM Communication
Phenytoin and Fosphenytoin and Serious Skin Reactions12/03/2008National PBM Communication
Erlotinib (Tarceva) and Hepatic Impairment12/01/2008National PBM Communication
ETHEX Recall11/14/2008National PBM Communication
ETHEX Propafenone Recall Patient Letter11/12/2008National PBM Communication
ETHEX Recall11/12/2008National PBM Communication
Concentrated Opioid Solutions and Concentration Confusion11/12/2008National PBM Bulletin
Natalizumab and PML10/31/2008National PBM Communication
Varenicline and Increase in Reports of Serious Adverse Events10/28/2008National PBM Communication
Iron Dextran and the Adverse Drug Events Associated with the High Molecular Weight Formulation  10/21/2008National PBM Bulletin
Calcium and Vitamin D and Change in Formulation10/06/2008National PBM Bulletin
Look-Alike Error with Acetic Acid and Sterile Water Irrigation10/02/2008National PBM Bulletin
Rituximab and PML9/19/2008National PBM Communication
TNF Inhibitors and the Risk for Invasive Fungal Infections09/05/2008National PBM Bulletin
EPOGEN® and Amgen Announcing Nationwide Voluntary Recall08/28/2008Patient Letter
EPOGEN® and Amgen Announcing Nationwide Voluntary Recall08/28/2008National PBM Communication
Natalizumab and PML08/27/2008National PBM Communication
Ezetimibe/Simvastatin (Vytorin®), Simvastatin, and Ezetimibe (Zetia®) and Risk for Cancer08/26/2008National PBM Communication
Naltrexone Injection Site Reactions08/20/2008National PBM Alert
Exenatide (Byetta) and Hemorrhagic and Necrotizing Pancreatitis08/19/2008National PBM Response
Naltrexone Injection Site Reactions8/20/2008National PBM Alert
Simvastatin and Amiodarone Drug-Drug Interaction8/18/2008National PBM Response
Mitoxantrone and Recommendations for Increased Monitoring8/18/2008National PBM Response
PROCRIT® (EPOETIN ALFA) LOT NUMBER P114942A and Nationwide Voluntary Recall of Ortho Biotech8/8/2008National PBM Response
PROCRIT® (EPOETIN ALFA) LOT NUMBER P114942A and Nationwide Voluntary Recall of Ortho Biotech – Patient Letter8/8/2008Patient Letter
Erythropoiesis Stimulating Agents (ESAs ):  FDA Labeling Changes for Cancer Patients Receiving Myelosuppressive Chemotherapy8/8/2008National PBM Update Alert
Topical Thrombin and Safety Issues if Used Intravascularly8/7/2008National PBM Alert
Bevacizumab Plus Sunitinib and Potential for Developing Microangiopathic Hemolytic Anemia7/31/2008National 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 Labeling7/18/2008National 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)7/17/2008National 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)7/17/2008Patient Letter
Fluoroquinolone Use and the Potential for Tendinitis and Tendon Rupture7/10/2008National PBM Bulletin
CellCept® (mycophenolate mofetil) and Cases of Progressive Multifocal Leukoencephalopathy (PML)7/1/2008National PBM Bulletin
Varenicline (marketed as Chantix) and Recent Safety Issues6/20/2008Patient Letter (VA Secretary)
Antipsychotic Use and Increase Risk of Death in Patients with Dementia-Related Psychosis6/16/2008FDA Information for Healthcare Professionals
Becaplermin (Regranex) Safety Information and Labeling Changes 6/11/2008National PBM Bulletin
Tumor Necrosis Factor (TNF) Antagonists and the Development of Lymphomas and Other Cancers in Children and Young Adults (< 18 years)6/4/2008FDA Early Communication
Varenicline (marketed as Chantix) and Recent Safety Issues5/30/2008National PBM Bulletin Addendum
Varenicline (marketed as Chantix) and Recent Safety Issues5/30/2008VA Patient Letter
Aprotinin (Trasylol®) and Increased Risk of Death and Other Serious Adverse Events – Temporary Suspension in Marketing5/16/2008National PBM Bulletin
Use of Abacavir or Didanosine and Higher Risk of Heart Attack4/4/2008National HIV/AIDS Program Commentary
Heparin Manufacturer Recalls4/2/2008B. Braun Internal Distribution Letter
Heparin Manufacturer Recalls3/28/2008FDA Firm Press Release – Covidien Voluntary recall of Heparin Pre-Filled Syringes
Use of Abacavir or Didanosine and Higher Risk of Heart Attack3/27/2008FDA Early Communication
Heparin Manufacturer Recalls3/27/2008Advanced Medical Internal Distribution Letter
Heparin Manufacturer Recalls3/21/2008Advanced Medical Manufacturer Letter
Heparin Manufacturer Recalls3/25/2008Advanced Medical Important Notice
Heparin Manufacturer Recalls3/21/2008FDA Firm Press Release for B.Braun Medical, Inc.
Heparin Manufacturer Recalls3/20/2008B.Braun Urgent Drug Recall
Update: Baxter Heparin Sodium Recall – Alternatives to Heparin Sodium3/19/2008Update
Etanercept and Tuberculosis and Infections 3/14/2008Dear Healthcare Professional Letter (Amgen)
EPOGEN®/PROCRIT® and Aranesp® and Additional Trials Showing Increased Mortality and/or Tumor Progression3/7/2008Dear Healthcare Professional Letter (Amgen)
Update: Baxter Heparin Sodium Recall3/3/2008Update B. Braun – April 2008
Calcium Supplements and Cardiovascular Disease in Older Women3/1/2008Review of a recent BMJ Article
Baxter - Allergic Reactions to Heparin Sodium2/19/2008National PBM Bulletin
Antiepileptic Drugs and Suicidality2/11/2008National PBM Bulletin
Temsirolimus (Torisel®) Final Dose Concentration2/7/2008 National PBM Bulletin Addendum
Temsirolimus (Torisel®) Final Dose Concentration1/22/2008National PBM Bulletin
Haloperidol and Cyanocobalamin 1ML Vials – Look-Alike Safety Alert12/20/2007National PBM Bulletin
IV Haloperidol and Torsades de Pointe11/28/2007Updated Labeling
Myfortic® (mycophenolic acid) and Increased Risks of Pregnancy Loss and Congenital Malformations / Change from Pregnancy Category C to Pregnancy Category D11/27/2007Dear Healthcare Professional Letter (Novartis)
Varenicline (marketed as Chantix) and Suicidal Thoughts and Aggressive or Erratic Behavior11/20/2007FDA Early Communication
Varenicline (marketed as Chantix) and Suicidal Thoughts and Aggressive or Erratic Behavior11/20/2007FDA Patient Information Sheet
Varenicline (marketed as Chantix) and Suicidal Thoughts and Aggressive or Erratic Behavior11/20/2007PBM Update: Varenicline Safety
Rosiglitazone and Increased Risk of Myocardial Ischemia11/19/2007FDA Information for Healthcare Professionals
Erythropoiesis Stimulating Agents Safety Alert11/15/2007National PBM Bulletin Addendum
Sildenafil (marketed as Viagra and Revatio) Vardenafil (marketed as Levitra) Tadalafil (marketed as Cialis) and Hearing Loss11/14/2007FDA Information for Healthcare Professionals
Cefipime (marketed as Maxipime) and Increased Mortality11/14/2007FDA Early Communication
Aprotinin (Trasylol®) and Increased Risk of Death and Other Serious Adverse Events – Temporary Suspension in Marketing11/6/2007National PBM Bulletin
Codeine Use in Breast-Feeding Women10/9/2007National PBM Bulletin
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE9/28/2007National PBM Bulletin
IV Haloperidol and Torsades de Pointe9/17/2007FDA MedWatch Summary
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE9/11/2007FDA Alert
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE9/11/2007Information for Healthcare Professionals (FDA)
Viracept (nelfinavir mesylate) and presence of ethyl methanesulfonate (EMS), a process-related impurity9/10/2007FDA 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) 8/16/2007Dear Healthcare Professional Letter (Bristol-Myers Squibb)
Rosiglitazone and Risk of Heart Failure8/14/2007FDA Information for Healthcare Professionals
Pioglitazone and Risk of Heart Failure8/14/2007FDA Information for Healthcare Professionals
Omeprazole (Prilosec®) and Esomeprazole (Nexium®) and Cardiovascular Events8/9/2007Early Communication about an Ongoing Safety Review
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE8/1/2007Dear Healthcare Professional Letter (Roche)
Omalizumab (Xolair®) and Anaphylactic Reactions7/10/2007National PBM Bulletin
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products7/5/2007FDA Alert
Trimetrexate Glucuronate (Neutrexin®) and Drug Discontinuation3/16/2007Dear Healthcare Professional Letter
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products6/1/2007Dear Healthcare Professional Letter
Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance) and Risk for Nephrogenic Systemic Fibrosis5/23/2007FDA Alert
Rosiglitazone (Avandia®) and Cardiovascular Events5/22/2007Information for Healthcare Professionals
Rosiglitazone (Avandia®) and Cardiovascular Events5/21/2007FDA Alert
Rosiglitazone (Avandia®) and Cardiovascular Events5/21/2007FDA News
Pergolide (Permax®) and Heart Valve Damage5/14/2007National PBM Bulletin
Antidepressant Medications and New Warnings About Suicidal Thinking, Behavior in Young Adults 5/2/2007FDA Press Release
Ceftriaxone (Rocephin®) and Incompatibility with Calcium Products UPDATE5/1/2007Prescribing Information (Roche)
Zolpidem (Ambien®) High Dose Use and Dose-Related Adverse Events5/1/2007Review of Various Trials Using Zolpidem at Higher Doses
Look-Alike Sound-Alike Confusion Potential with Humapen Memoir® and Humira® Pen4/5/2007Humira Pen and HumaPen; ISMP Newsletter
Tegaserod and Discontinued Marketing for Safety Reasons4/3/2007National PBM Bulletin
Methadone (Dolophine®) and Serious Side Effects4/1/2007Methadone Related Deaths; PBM Ez Minutes April-June 2007
Pergolide (Permax®) and Heart Valve Damage3/29/2007 FDA Public Health Advisory
Lamivudine and Zidovudine (Combivir®) Tablets and Counterfeit Labeling3/28/2007Dear Pharmacy Professional Letter
Linezolid (Zyvox®) and Increased Mortality3/16/2007FDA Alert
Linezolid (Zyvox®) and Increased Mortality3/16/2007Healthcare Professional Sheet
Telithromycin (Ketek®) and Safety Issues3/1/2007Dear Healthcare Professional Letter
Omalizumab (Xolair®) and Anaphylactic Reactions2/21/2007FDA Alert
Omalizumab (Xolair®) and Anaphylactic Reactions2/21/2007FDA News
Omalizumab (Xolair®) and Anaphylactic Reactions2/21/2007Healthcare Professional Sheet
Telithromycin (Ketek®) and Serious Liver Toxicity2/12/2007FDA News – Label and Indication Changes
Telithromycin (Ketek®) and Serious Liver Toxicity2/12/2007Questions and Answers on Telithromycin
Quinine and Unapproved Use for Leg Cramps Due to Serious Side Effects2/8/2007National PBM Bulletin
IV Promethazine (Phenergan®) and Tissue Injury2/1/2007A Guidance on IV Promethazine Use and Safety Issues
Erythropoiesis Stimulating Agents Safety Alert1/9/2007National PBM Bulletin
Erythropoiesis Stimulating Agents Safety Alert1/9/2007Safety Concerns of Erythropoiesis Stimulating Agents
Look-Alike Sound-Alike Confusion Potential with Humapen Memoir® and Humira® Pen1/1/2007Two Pens Different Uses; PBM Ez-Minutes January-March 2007
Quinine and Unapproved Use for Leg Cramps Due to Serious Side Effects1/1/2007Quinine Not for Leg Cramps Anymore; PBM Ez-Minutes January-March 2007
Rituximab (Rituxan®) and Progressive Multifocal Leukoencephalopathy12/18/2006FDA Alert
Rituximab (Rituxan®) and Progressive Multifocal Leukoencephalopathy12/18/2006FDA Information for Healthcare Professionals
Quinine and Unapproved Use for Leg Cramps Due to Serious Side Effects12/11/2006FDA News
Quinine and Unapproved Use for Leg Cramps Due to Serious Side Effects12/11/2006FDA Questions and Answers on Unapproved Quinine Products
Methadone (Dolophine®) and Serious Side Effects 11/30/2006National PBM Bulletin
Methadone (Dolophine®) and Serious Side Effects11/30/2006VAMedSAFE Bulletin
Methadone (Dolophine®) and Serious Side Effects11/27/2006FDA Alert
Methadone (Dolophine®) and Serious Side Effects11/27/2006Healthcare Provider Information
Oseltamivir Phosphate (Tamiflu®) and Precaution for Neuropsychiatric Events 11/13/2006Dear Healthcare Professional Letter
Fluarix® and Twinrix® Look-Alike Confusion Potential 11/1/2006National PBM Bulletin
Bevacizumab10/1/2006National PBM Bulletin
Look-Alike Sound-Alike Vaccine Mix-ups: Adacel (Tdap) and Daptacel (DTaP) 8/24/2006ISMP Newsletter
IV Promethazine (Phenergan®) and Tissue Injury 8/10/2006ISMP Newsletter
Telithromycin (Ketek®) and Serious Liver Toxicity7/5/2006Questions and Answers on Telithromycin
Telithromycin (Ketek®) and Serious Liver Toxicity6/29/2006FDA News for New Product Labeling Regarding Safety Issues
Benzocaine2/28/2006A Guidance on the Use of topical Anesthetics for Naso/Oropharyngeal and Laryngotracheal Procedures
Benzocaine2/10/2006FDA Public Health Advisory
Benzocaine2/8/2006NCPS Patient Safety Alert
Telithromycin (Ketek®) and Serious Liver Toxicity1/20/2006FDA Public Health Advisory
Telithromycin (Ketek®) and Serious Liver Toxicity1/20/2006Questions and Answers on Telithromycin
Benzocaine10/1/2005VAMedSAFE Patient Safety Issues – Benzocaine (Hurricaine Spray); PBM Ez-Minutes October-December 2005
Phosphodiesterase 5 Inhibitors and Loss of Vision8/5/2005National PBM Bulletin
Clinical Guidance on Replacement Product Recommendations for Avandamet and Paxil CR in the VA 3/29/2005National PBM Bulletin
Vitamin E1/13/2005National PBM Bulletin
Ethyl Chloride Safety Awareness1/1/2005Ethyl Chloride Ignites; PBM Ez-Minutes January-March 2005
Fentanyl Transdermal Patch12/22/2004National PBM Bulletin
HIV Agents New on Formulary12/21/2004National PBM Bulletin
Vitamin E12/1/2004VAMedSAFE Bulletin
Vitamin E12/1/2004Background: High Dose Vitamin E (> 400IU/Day)
Statins9/1/2004Statin-Fibrate Report – Focus on Safety
Rofecoxib7/21/2004National PBM Bulletin
Statins12/1/2001Recommendations 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 Abuse12/1/2001VA Office of Inspector General Pharmaceutical Bulletin