Safety Issue
(click here to sort) |
Date
(click here to sort) | Safety Information |
| 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 |
| Naltrexone Injection Site Reactions | 8/20/2008 | National PBM Alert |
| 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 |