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Pharmacy Benefits Management Services

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
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



 

 



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