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Latest drug alerts and warnings.

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Sorted by Date

Date Title
11/06/2009 Remifentanil Hydrochloride (Ultiva) – Typographical Error in the Handbook on Injectable Drugs
11/06/2009 Dietary Supplements for Erectile Dysfunction – Dangerous Ingredients – UPDATED
11/04/2009 Body Building Products Containing Unapproved Synthetic Steroids – FDA Issues Warning
11/03/2009 Exenatide (Byetta®) – Altered Kidney Function Reported
10/28/2009 Accusure Insulin Syringe Recall - updated
10/26/2009 Peramivir Injection – Emergency Use Authorization for H1N1 Influenza
10/26/2009 Rituximab (Rituxan®) and Progressive Multifocal Leukoencephalopathy (PML) - UPDATE
10/22/2009 Ketorolac Tromethamine Injection – Voluntary Recall
10/20/2009 Iron dextran injection (Dexferrum) – Black Box Warning for Potentially Fatal Anaphylactic Reaction
10/19/2009 Disposal of Prescription Medications in the Community - New Federal Guidelines - UPDATED
10/09/2009 Zanamivir (Relenza) – Potentially Fatal if Nebulized
10/05/2009 Heparin: Change in Reference Standard- New Universal Standardization in Heparin Potency
10/01/2009 Acetaminophen (Tylenol®) Pediatric Liquid Products Recalled Due to Possible Bacterial Contamination - UPDATED
09/29/2009 Sitagliptin (Januvia) and sitagliptin/metformin (Janumet) – Reports of Acute Pancreatitis
09/29/2009 Oseltamivir (Tamiflu) Oral Suspension—Potential for Dosing Errors
09/28/2009 Deferasirox (Exjade): Early Communication about an Ongoing Safety Review
09/25/2009 FDA Warns Pharmacies Against Compounding Topical Anesthetic Creams and Other Products
09/22/2008 Natalizumab (Tysabri) Monotherapy and Progressive Multifocal Leukoencephalopathy - UPDATE
09/17/2009 Promethazine Hydrochloride Injection – Black Box Warning for Severe Tissue Injury
09/09/2009 Mycophenolic Acid (Myfortic®) – warning for risk of Pure Red Cell Aplasia (PRCA)
09/03/2009 Etravirine (Intelence™): Severe Skin and Hypersensitivity Reactions
09/02/2009 Anti-Tumor Necrosis Factor (TNF) Agents (adalimumab [Humira], certolizumab pegol [Cimzia], etanercept [Enbrel], infliximab [Remicade], golimumab [Simponi]) —Ongoing Safety Review of Malignancy Risk - UPDATE
08/28/2009 Orlistat (Xenical and Alli): Ongoing Safety Review
08/26/2009 Insulin Detemir (Levemir) – Stolen Vials Resurface, Product Potentially Defective
08/26/2009 Ibuprofen topical OTC formulations marketed unlawfully – Warning letters issued by the FDA
08/18/2009 Dextroamphetamine/Amphetamine 20 mg Tablet Recall by Barr
08/17/2009 Correction Notice – Typographical Errors in Pediatric Injectable Drugs, 8th Edition (The Teddy Bear Book)
08/17/2009 Mycophenolate Mofetil (CellCept®) associated with Pure Red Cell Aplasia (PRCA)
08/14/2009 Galactose, Maltose, and Xylose Products May Falsely Elevate Glucose Results – Update
08/11/2009 Midazolam Hydrochloride and Furosemide – Potential for Error
08/07/2009 Alaris System Class I Recall
08/07/2009 Erythropoiesis-Stimulating Agents (Darbepoetin alfa [Aranesp], Erythropoietin alfa [Epogen, Procrit]) – Proposed Changes in Product Labeling
08/06/2009 Magnesium Sulfate and Potassium Phosphate – Potential for Error
08/04/2009 Botulinum Toxin Types A (Botox, Botox Cosmetic, Dysport) and Botulinum Toxin Type B (Myobloc) – Safety Review Update and Names Changed to OnabotulinumtoxinA (Botox, Botox Cosmetic), AbobotulinumtoxinA (Dysport), and RimabotulinumtoxinB (Myobloc)
08/03/2009 Oral Colchicine (Colcrys) – Severe Drug Interactions with Strong CYP3A4 and P-glycoprotein Inhibitors
07/28/2009 Electronic Cigarette – A Potential Health Hazard
07/27/2009 Sanofi-Aventis Medications Stolen – Verify Drug Pedigrees
07/23/2009 Astellas Recall of Lots of Several Medications Due to Stolen Transport Trailer
07/20/2009 Prevnar (Pneumococcal 7-valent Conjugate) Vaccine Recall
07/17/2009 Propofol (Teva) – Recall of Two Lots Due to Presence of Endotoxin - Update
07/17/2009 Weight Loss Products Containing Undeclared Active Ingredients
07/16/2009 Omalizumab (Xolair®) – Ongoing Safety Review Update
07/16/2009 Acetaminophen Concentrated Drops – Brookstone Pharmaceuticals Voluntary Recall Due to Packaging Concerns
07/16/2009 Propofol (Teva) – Recall of Two Lots Due to Presence of Endotoxin
07/16/2009 Immunosuppressant Drugs – Labeling Changes Warning of Increased Risk of Opportunistic Infections
07/13/2009 Sodium Chromate Cr-51 Injection Recall
07/10/2009 Stealth Powdered Dietary Supplements – Recall due to possible Salmonella
07/09/2009 Propoxyphene – Labeling Changes to Prevent Overdose
07/06/2009 Creon – Newly Approved Formulation Requires New Prescription
07/06/2009 Bupropion (Zyban and generics) – Neuropsychiatric Events and Suicidality Warnings added to the Prescribing Information - Update
07/01/2009 Insulin Glargine (Lantus) – Risk of Cancer
07/01/2009 Varenicline (Chantix) – Neuropsychiatric Events and Suicidality Warnings added to the Prescribing Information - Update
07/01/2009 Acetaminophen – FDA Actions to Prevent Overdose
06/30/2009 Caraco Medications Seized by US Marshals Due to Ongoing Quality Problems UPDATED
06/30/2009 Tumor Necrosis Factor (TNF) Blocking Agents (adalimumab [Humira], certolizumab pegol [Cimzia], etanercept [Enbrel], golimimumab [Simponi], infliximab [Remicade])—Risk of Delayed Diagnosis of Opportunistic Infections
06/29/2009 Topical Anesthetic Agents for Medical and Cosmetic Procedures – Potentially Fatal Adverse Effects UPDATED
06/29/2009 Astellas Recall of Lots of Several Medications Due to Stolen Transport Trailer
06/24/2009 “Total Body Formula” and “Total Body Mega Formula”- High Selenium Concentrations UPDATED
06/18/2009 Cefepime (Maxipime) - Ongoing Safety Review - Updated
06/16/2009 Zicam Cold Remedy Nasal Products Associated with Loss of Sense of Smell
06/16/2009 Stimulant Medications for Attention-Deficit/Hyperactivity Disorder – Safety Review
06/15/2009 Sirolimus (Rapamune®) – Safety in Liver Transplant Patients
06/12/2009 Montelukast (Singulair) and Risk of Behavior Changes, Mood Changes, or Suicidality - Ongoing Safety Review
06/11/2009 Clarcon Hand Sanitizers and Skin Protectants Recall
06/03/2009 Propylthiouracil (PTU) – Risk of Hepatotoxicity
06/03/2009 ACCU-CHEK Softclix Lancet Recall
05/19/2009 Utah Medicaid Preferred Drug List Update
05/13/2009 Digoxin Tablet Recall by Caraco - UPDATED
05/08/2009 Erlotinib (Tarceva) and New Safety Information
05/08/2009 Testosterone Gel Products and Inadvertent Exposure in Children
05/06/2009 Antiepileptic Drugs and Increased Risk of Suicidal Behavior or Suicidal Ideation
05/04/2009 Hydroxycut Consumer Warning and Product Recall
04/29/2009 Non-Acetone Nail Polish Remover (Personal Care Products) – Recall, Potential for Chemical Burns
04/14/2009 Ceftriaxone Injection (Rocephin) – Interaction with Calcium Products and New Contraindication in Hyperbilirubinemic Neonates – Update
04/13/2009 Efalizumab (Raptiva®) withdrawal
03/25/2009 Propafenone HCL 225 mg tablet recall by Watson
03/24/2009 Mycophenolate products (Cellcept – mycophenolate mofetil, Myfortic – mycophenolic acid) – Medication Guide Now Required
03/20/2009 Insulin Pens and Cartridges – Risk of Blood-Borne Disease Transmission with Shared Use
03/06/2009 Transdermal Patches with Metallic Backings – Risk of Burns if Worn During Magnetic Resonance Imaging Scans
02/27/2009 Metoclopramide (Reglan, generic) – Black Box Warning for Tardive Dyskinesia
02/23/2009 Zonisamide (Zonegran® and Generics) – Risk of Metabolic Acidosis
02/20/2009 Efalizumab (Raptiva) and Progressive Multifocal Leukoencephalopathy (Update)
02/20/2009 Flu Vaccine Update - Keep Vaccinating
02/10/2009 Ethex Recalls Additional Products More Than 60 Drug Products—Update
02/09/2009 Vecuronium Bromide for Injection Recall by Hospira
02/05/2009 Drotrecogin alfa [activated] (Xigris) – Ongoing Safety Review
01/29/2009 Venom Hyperdrive dietary supplement contains undeclared sibutramine
01/27/2009 Clopidogrel Bisulfate (Plavix) – Potential Interactions – Ongoing Safety Review
01/14/2009 Ultram ER Voluntary Recall
01/12/2009 Ezetimibe/Simvastatin versus Simvastatin Alone (ENHANCE) – Update of Ongoing Data Review
01/05/2009 Tramadol injection – Typographical Error in the Handbook on Injectable Drugs
01/02/2009 Fentanyl 50 mcg/hour Transdermal System Recall (Duragesic - Janssen, generic - Sandoz)
12/31/2008 Tinzaparin - Increased Risk of Mortality - Ongoing Safety Analysis
12/24/2008 Hydromorphone 2 mg Tablet Recall by Ethex
12/24/2008 KV Pharmaceutical Tablet Shipment Suspension
12/12/2008 Oral Sodium Phosphate Products for Bowel Cleansing - Renal Adverse Effects - UPDATE
12/12/2008 Advanced Medical Optics Recall - Healon D Ophthalmic Viscosurgical Device
12/09/2008 Hospira Recall - Potassium 20 mEq in 5% Dextrose/ 0.45% Sodium Chloride
12/01/2008 STARCAPS Diet System Capsules May Contain Bumetanide
12/01/2008 Zhen De Shou Dietary Supplement Contains Undeclared Sibutramine
11/25/2008 Phenytoin and Fosphenytoin - Skin Reactions More Common in Patients with the Human Leukocyte Antigen Allele, HLA*B 1502.
11/21/2008 Corvalol - Unapproved Drug Contains Phenobarbital
11/18/2008 Benzoyl Peroxide 10% Topical Acne Gel - Product Recall
11/13/2008 Infants' Mylicon Gas Relief Dye Free Drops Recall
11/13/2008 Bisphosphonates - Update of Safety Review of FDA Early Communication Regarding Atrial Fibrillation
11/07/2008 Insulin Syringe (ReliOn) Recall
10/17/2008 Dextroamphetamine sulfate 5 mg tablets by Ethex recall
10/10/2008 Cough and Cold Medications Update - Infant Deaths and Use in Children UPDATED
10/08/2008 Tiotropium (Spiriva) and Risk of Stroke - Ongoing Safety Review UPDATED
09/30/2008 HMG-CoA-reductase inhibitors do not increase incidence of amyotrophic lateral sclerosis (AML)
09/30/2008 Epoetin alfa (Eprex) in the Treatment of Acute Ischemic Stroke
09/25/2008 Ammonul (sodium phenylacetate and sodium benzoate) Injection - Filter Required
09/24/2008 Erlotinib (Tarceva) and Hepatic Dysfunction
09/19/2008 Phosphocol P 32 - Increased Risk of Leukemia and Radiation Injury
08/21/2008 Simvastatin/Ezetimibe (Vytorin) and Increased Risk for Cancer - Ongoing Safety Review
08/20/2008 Exenatide (Byetta) and Pancreatitis - Update
08/13/2008 Naltrexone Extended-Release Injectable Suspension (Vivitrol) – Injection Site Reactions
08/11/2008 Simvastatin products (Zocor, Zetia, Simcor, generic) and Amiodarone (Cordarone, Pacerone, generic) - Potentially Serious Interaction
08/05/2008 Actavis Drug Recall
07/30/2008 Mitoxantrone (Novantrone) - Cardiac Monitoring
07/29/2008 Abacavir (Ziagen) and Abacavir-Containing Medications - Patient Screening Recommended
07/25/2008 Human Papillomavirus Recombinant Quadrivalent Vaccine, Types 6, 11, 16, 18 (Gardasil®) -Safety Update
07/17/2008 Micro-bubble Perflutren Contrast Agents (Definity and Optison) Associated with Deaths and Serious Cardiopulmonary Reactions - Update
07/17/2008 Sodium Polystyrene Sulfonate - Recall Due to Contamination with Yeast
07/14/2008 Bevacizumab (Avastin®) and sunitinib (Sutent®) – combined use may increase risk of microangiopathic hemolytic anemia
07/11/2008 Trastuzumab (Herceptin) and Bacteriostatic Water for Injection Diluent Vials - Potential Vial Damage
07/09/2008 Nifedipine (Nifediac™ CC) Extended Release Tablets- Recall
07/09/2008 Fluoroquinolones and Tendinitis and Tendon Rupture
07/02/2008 Chlorhexidine Gluconate Skin Preparation Cloth - Recall
06/30/2008 Mycophenolate Mofetil (CellCept) and Mycophenolate Acid (Myfortic) and risk of Progressive Multifocal Leukoencephalopathy - Ongoing Safety Review - Updated
06/27/2008 Cyclopentolate and Tropicamide Administration Errors
06/18/2008 Heparin - Voluntary Recall of Baxter Heparin Vials, B. Braun Heparin Large Volume Infusion Bags, and Covidien (Kendall) Heparin Flush Prefilled Syringes - Update
06/16/2008 Conventional and Atypical Antipsychotics-Increased Risk of Death in Elderly Patients Taking Antipsychotics for Dementia-Related Psychosis
06/10/2008 Becaplermin Gel (Regranex) and Risk of Cancer Death - Ongoing Safety Review
06/04/2008 Calcilo XD Infant Formula - Product Recall
05/30/2008 Mommy's Bliss Nipple Cream - Harmful Ingredients for Nursing Babies
05/21/2008 Minocycline (Solodyn) - Two lots recalled due to product mix-up
05/16/2008 Mycophenolate Mofetil (Cellcept) and Mycophenolic Acid (Myfortic) and Birth Defect Risk
05/07/2008 Alcohol-Free Mouthwash - Recall
05/02/2008 Etanercept (Enbrel) Black Box Warning of Infection Risk
04/29/2008 Actavis Totowa Digoxin (Digitek®) Recall
04/24/2008 Hydrocodone Long-Acting Antitussives (Tussionex) - Safe Use
04/10/2008 Inhaled Insulin (Exubera) and Lung Cancer
04/10/2008 Daptomycin (Cubicin) – MBT Contaminant When Stored in ReadyMED Elastomeric Pump
04/10/2008 Rotigotine Transdermal Systems Patch
04/03/2008 Tegaserod (Zelnorm) - Discontinued, No Longer Available Through Treatment Investigational New Drug Protocol- UPDATE
04/03/2008 Neuraminidase Inhibitors, Oseltamivir Phosphate (Tamiflu) and Zanamivir (Relenza), Associated with Neuropsychiatric Events
03/28/2008 Abacavir and Didanosine and Risk of Heart Attack - Ongoing Safety Review
03/25/2008 Sargramostim (Leukine) Liquid Formulation Withdrawn from Market; Special Access Program for Powder Formulation - Update
03/14/2008 Erythropoiesis-Stimulating Agents (Darbepoetin alfa [Aranesp], Epoetin alfa [Epogen, Procrit]) - Revised Black Box Warnings-Update
03/14/2008 Darunavir (Prezista)- Hepatotoxicity Warnings
03/11/2008 Icy Hot Heat Therapy Products - Recall
03/07/2008 Unapproved and Misbranded Drugs for Prevention and Treatment of STDs Marketed over the Internet
03/06/2008 Immune Globulin (GamaSTAN S/D™) - Uncalibrated Syringes
03/04/2008 Correct Use of Tiotropium Bromide (Spiriva) and Formoterol Fumarate (Foradil) Capsules
03/04/2008 Fentanyl Transdermal System Recall (Actavis, Abrika) - UPDATE
03/04/2008 Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) - Ongoing Safety Review
02/29/2008 Natalizumab (Tysabri) - Reports of Liver Injury after Natalizumab Use
02/25/2008 Rabies Immune Globulin (HyperRAB S/D) - Uncalibrated Syringes
02/19/2008 Fentanyl 25 mcg/hour Transdermal System Recall (Duragesic - Janssen, generic - Sandoz)
02/06/2008 FDA Bans the Manufacture of Unapproved Injectable Colchicine Products
02/01/2008 NuCel Labs “Eye Drops” and “Eye/Ear Wash” Recalled
01/23/2008 Heparin Lock Flush Pre-filled Syringes and Normal Saline Pre-filled Flush Syringes Recalled by AM2 PAT, Inc. - Update
01/23/2008 Ortho Evra® (norelgestromin/ethinyl estradiol) Labeling Update
01/22/2008 Edetate Disodium - Sound-Alike Confusion with Edetate Calcium Disodium
01/11/2008 Bioidentical Hormone Replacement Therapy - Misleading Information
01/08/2008 Bisphosphonates (alendronate [Fosamax, Fosamax plus D], etidronate [Didronel], ibandronate [Boniva], pamidronate [Aredia], risedronate [Actonel, Actonel and calcium], tiludronate [Skelid], zoledronic acid [Reclast, Zometa]) – Bone, Joint, and Musculoskeletal Pain Reminder
12/24/2007 Fentanyl Transdermal Patch (Duragesic, generics) - Cautions About Safe and Appropriate Use
12/14/2007 Deferasirox (Exjade) - Potentially Fatal Renal, Hepatic, Hematologic, and Allergic Events
12/12/2007 Carbamazepine (Tegretol) - Skin Reactions More Common in Patients with Human Leukocyte Antigen B*1502 Allele
12/12/2007 Omeprazole (Prilosec/Zegerid/generic) and Esomeprazole (Nexium) - Possible Association with Cardiac Events
12/06/2007 Desmopressin - Risk of Hyponatremia and Seizures
11/27/2007 Mycophenolate Products (Cellcept, Myfortic) – Pregnancy Risk Category Updated
11/15/2007 Rosiglitazone (Avandia) - Possible Association with Ischemic Cardiovascular Events - UPDATED
11/5/2007 Aprotinin (Trasylol) Marketing Temporarily Suspended Pending Ongoing Safety Review - Update
11/2/2007 NC Solution, and other Products by General Therapeutics Corp. Seized
10/25/2007 Modafanil (Provigil) - Rash and Psychiatric Warnings
10/11/2007 Cochlear Implant Device Increases Risk of Pneumococcal Meningitis – Immunization Recommended
9/28/2007 Gadolinium-Containing Contrast Agents (Omniscan®/OptiMARK®/Magnevist®/ProHance®/MultiHance®) Possible Association With Serious Nephrogenic Fibroses — UPDATE
9/28/2007 Hydrocodone Antitussives - FDA Halts Marketing of Unapproved Products
9/28/2007 Fentanyl Buccal Tablet (Fentora®) - Inappropriate Use Causes Death/Adverse Effects— UPDATED
9/28/2007 Medicaid Tamper-Resistant Requirement - Delayed 6 Months
9/28/2007 Baby's Bliss Gripe Water by MOM Enterprises Recalled
9/19/2007 B. Braun Normal Saline Flush Recall
9/19/2007 Haloperidol - Updated Labeling Regarding Risk of Torsades de Pointes and QT Prolongation
9/14/2007 Nelfinavir Mesylate (Viracept) - New Impurity Specifications
9/13/2007 Abbott Blood Glucose Meter Display Problems
9/7/2007 Daytrana™ (Methylphenidate Transdermal System) Recall
8/27/2007 National Provider Identifier (NPI) - Personal Information Alert — UPDATED
8/22/2007 METABOSLIM Dietary Supplement Contains Undeclared Sibutramine — UPDATED
8/20/2007 Entecavir (Baraclude) and Possible HIV Resistance — UPDATED
8/20/2007 Warfarin - Pharmacogenomic Labeling Changes
8/17/2007 Codeine use in Nursing Mothers with a Specific CYP2D6 Genotype may lead to Morphine Overdose in the Nursing Infant
8/16/2007 Omega-3-acid Ethyl Esters Brand Name Changed from Omacor to Lovaza
8/15/2007 Lopinavir/Ritonavir Oral Solution (Kaletra) - Potential Risk of Overdose in Children
8/15/2007 Rosiglitazone (Avandia) and Pioglitazone (Actos) - Stronger Warnings about Heart Failure
8/14/2007 Red Yeast Rice Supplements 5/Contain Lovastatin
8/8/2007 Tigecycline (Tygacil®) Reformulation
7/9/2007 Ertapenem Sodium (Invanz) Recall
7/5/2007 Oxycodone Extended-Release Tablets From Endo, Dava, and Watson - Discontinued
7/3/2007 Omalizumab (Xolair) - Reports of Delayed Anaphylaxis
7/2/2007 Colistimethate (Coly-Mycin M®, generics) Inhalation Possibly Associated With Death
6/19/2007 Live Oral Pentavalent Rotavirus Vaccine (RotaTeq) – Reports of Kawasaki Disease
6/19/2007 Propofol (Diprivan/generics) - Adverse Events Resembling Bacterial Sepsis
5/30/2007 Infant Formula with Iron Recall - Abbott Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature
5/30/2007 Advanced Medical Optics Contact Lens Solution Recall
5/23/2007 Gadolinium-Containing Contrast Agents (Omniscan®/OptiMARK®/Magnevist®/ProHance®/MultiHance®) Possible Association With Serious Nephrogenic Fibroses — UPDATE
5/22/2007 Caffeine Citrate Powder/Purified - Recall
5/11/2007 OxyContin (oxycodone extended-release) manufacturer pleads guilty to misbranding and misrepresenting product
5/7/2007 Antidepressants and Suicidality in Young Adults
5/3/2007 Colchicine Injection - Recall of Compounded Product
5/3/2007 Counterfeit Medications on the Internet – FDA Warning about Orlistat (Xenical)
4/27/2007 PharmaFab to Stop Manufacturing Unapproved Drugs
4/24/2007 Bevacizumab (Avastin) and Tracheoesophageal Fistula
4/12/2007 Tizanidine (Zanaflex) - Contraindicated with Fluvoxamine or Ciprofloxacin
4/12/2007 Alglucosidase Alfa (Myozyme) - Formation of Black Particles During Reconstitution
4/12/2007 Griseofulvin (Grifulvin V) Oral Suspension - Recall
4/12/2007 Abacavir Sulfate (Ziagen) and Lamivudine/Zidovudine (Combivir) – Third Party Tampering
4/9/2007 Trimethobenzamide Suppositories - Discontinued Due to Lack of Efficacy
3/30/2007 Pergolide Products Withdrawn From Market Due to Heart Valve Damage
3/29/2007 Accutane (Isotretinoin) - New Informational FDA web site
3/27/2007 Telithromycin (Ketek) Updated Warnings - updated
3/19/2007 Linezolid (Zyvox®) - Increased Mortality Following Treatment of Intravascular Catheter-Related Infections
3/15/2007 Sedative-Hypnotic Labeling Revisions
3/9/2007 Interferon Gamma-1b (Actimmune) - Early Termination of Trial for Idiopathic Pulmonary Fibrosis
3/9/2007 Pioglitazone (Actos/Actoplus Met/Duetact) and Rosiglitazone (Avandia/Avandamet/Avandaryl) Increased Fracture Risk - Update
3/7/2007 Salivart Oral Moisturizer Recall
3/5/2007 Ergotamine – FDA Halts Marketing of Unapproved Products
2/26/2007 Mycophenolate Mofetil (Cellcept) Plus Sirolimus (Rapamune) – Increased Acute Rejection In Cardiac Transplant Patients
2/23/2007 Hyperactivity Medications: Patient Medication Guide Required due to Cardiovascular and Psychiatric Adverse Effects
2/21/2007 Mislabeled Internet Medications – Dangerous Ingredients
2/20/2007 Erythropoiesis-Stimulating Agent (Darbepoetin alfa [Aranesp]) Increases Death in Non-Chemotherapy-Induced Anemia
2/20/2007 Live Oral Pentavalent Rotavirus Vaccine (RotaTeq) - Post-Marketing Reports of Intussusception
2/15/2007 Telithromycin (Ketek) Updated Warnings
2/12/2007 Heparin Administration Errors - Use of Incorrect Concentrations
2/2/2007 Daptacel (DTaP) and Adacel (Tdap) Administration Errors
2/2/2007 Ranibizumab (Lucentis®) 0.5 mg Increases Stroke Risk - UPDATED
1/2/2007 Floranex (Lactobacillus) and Florinef (fludrocortisone) Name Confusion
12/26/2006 Gadolinium-Containing Contrast Agents (Omniscan®/OptiMARK®/Magnevist®/ProHance®/MultiHance®) Possible Association With Serious Nephrogenic Fibroses — UPDATE
12/18/2006 Aprotinin (Trasylol): Increased Risk Of Myocardial Infarction/Stroke/Renal Dysfunction/and Anaphylaxis - Update
12/14/2006 Ketamine HCl (Ketalar) 10mg/mL Injection – Recall
12/13/2006 Quinine Sulfate - FDA Orders Halt of the Sale of Unapproved Products
12/12/2006 Heparin -Induced Thrombocytopenia - Delayed-Onset Warning
11/28/2006 Methadone Hydrochloride (Dolophine, generics) – Cardiac and Respiratory Deaths
11/20/2006 Epoetin alfa/Darbepoetin alfa: Hemoglobin Target above 12 g/dL Increases Cardiovascular Risk
11/10/2006 Acetaminophen 500 mg Tablets (Store Brands) - Recall
10/30/2006 Venlafaxine (Effexor®/Effexor XR®) - Overdose Risk
10/24/2006 Meningococcal Conjugate Vaccine Associated with Guillain Barré Syndrome
10/19/2006 Imatinib Mesylate (Gleevec®) - Cardiac Events
10/17/2006 OneTouch® Blood Glucose Test Strips - Counterfeit Alert
10/16/2006 DEA Numbers 5/Begin With Letter "F"
10/12/2006 Accutane and Generic Isotretinoin - iPLEDGE Risk Management Program Modification
10/11/2006 Warfarin Sodium (Coumadin®) - Patient Medication Guide and Black Box Warning
10/3/2006 Lamotrigine (Lamictal) During Pregnancy 5/Increase Risk of Cleft Lip or Cleft Palate
9/27/2006 Bevacizumab (Avastin®) and Risk of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) and Nasal Septum Perforation
9/21/2006 Norelgestromin/ethinyl estradiol patch (Ortho Evra) May Increase Blood Clot Risk
9/14/2006 Ibuprofen and Aspirin Drug Interaction
9/7/2006 Ephedrine alkaloids in dietary supplements illegal to market in US
9/7/2006 Famotidine and Lorazepam Administration Errors
8/22/2006 Dextroamphetamine (Dexedrine/Dexedrine Spansule) Labeling Changes/Including Sudden Death
8/18/2006 Hydralazine HCl 20mg/mL Injection - Recall
8/11/2006 Unapproved Compounded Inhalation Solutions May Not Be Safe
8/7/2006 Lamisil (Terbinafine) and Lamictal (Lamotrigine) Name Confusion
8/2/2006 Kaopectate and Generic Kaolin-Pectin Products - Reformulation
8/2/2006 Vapor Patch Voluntary Recall - Triaminic Vapor Patch and WellPatch Cough & Cold Soothing Vapor Pads
7/25/2006 Iopromide 370 mg/mL Injection (Ultravist) Recall
7/25/2006 Bismacine Injection (Chromacine) - Avoid Use for Lyme Disease
7/20/2006 SSRI Treatment During Pregnancy
7/20/2006 Serotonin Syndrome With Triptans Plus SSRIs or SNRIs
7/6/2006 Tipranavir Associated With Intracranial Hemorrhage
6/30/2006 Updated: Telithromycin/Cases of Severe Hepatotoxicity
6/23/2006 Triaminic Vapor Patch Voluntary Recall
6/12/2006 Gadolinium-Containing Contrast Agents (Omniscan®/OptiMARK®/Magnevist®/ProHance®/MultiHance®) Possible Association With Serious Nephrogenic Fibroses.
6/9/2006 Angiotensin-Converting Enzyme Inhibitors (ACE Inhibitors) Associated with Birth Defects in First Trimester
6/6/2006 Updated: Natalizumab (Tysabri) - Resumed Marketing With a Special Restricted Distribution Program
5/16/2006 Paroxetine (Paxil®/Paxil CR®) Labeling Changes - Suicidality in Adults
5/11/2006 Oral Sodium Phosphate Products for Bowel Cleansing - Renal Adverse Effects
5/5/2006 Recall of Goldline Brand Extra-Strength Acetaminophen 500 mg (Genapap/Genebs)
4/14/2006 Contact Lens Solutions: Fungal Eye Infections in Soft Contact Lens Wearers
4/7/2006 Pegaptanib Sodium Injection (Macugen): Labeling Changes Due to Reports of Anaphylaxis and Angioedema
3/31/2006 Diazepam Rectal Gel (Diastat Acudial): Applicator Defect 5/Prevent Delivery of Complete Dose.
3/20/2006 Mifepristone (Mifeprex/RU-486) associated with serious infection and bleeding - UPDATE
3/17/2006 Denileukin diftitox (Ontak) 5/Cause Visual Loss
3/14/2006 Steroid Products Sold Illegally as Dietary Supplements
3/6/2006 Salagen (pilocarpine) and Selegiline (Eldepryl) Name Confusion
3/3/2006 Bosentan (Tracleer) 5/Cause Hepatotoxicity
3/2/2006 Amicar and Omacor Dispensing Errors
2/24/2006 Infant Formula by Gentlease Recalled
2/17/2006 Quinolones and Blood Glucose Abnormalities (Hypoglycemia/Hyperglycemia)
2/17/2006 Gatifloxacin (Tequin) and Blood Glucose Abnormalities/Contraindicated in Diabetics
2/16/2006 Premarin/Prempro/and Premphase
2/15/2006 Balanced Salt Solution by Cytosol Labs Recalled
2/15/2006 Benzocaine Sprays - Increased Risk of Methemoglobinemia
2/1/2006 Nimodipine boxed warning: Do not give parenterally
1/26/2006 Hydroxyurea Associated Cutaneous Vasculitic Toxicities
1/24/2006 Potential Cancer Risk With Topical Pimecrolimus (Elidel) and Tacrolimus (Protopic) - Updated
1/23/2006 ACCU-CHEC glucose meter device recall
1/19/2006 Brazilian Diet Pills 5/Contain Chlordiazepoxide/Fluoxetine/or Stimulants
1/19/2006 Amantadine and Rimantadine/High Levels of Resistance By Influenza A H3N2 Viruses
1/13/2006 Clozapine Labeling Changes - White Blood Cell Count Monitoring Changes
1/12/2006 Rho(D) Immune Globulin Intravenous (WinRho) - Hematologic Safety Reports
1/12/2006 Rosiglitazone - New Onset or Worsening Macular Edema
1/10/2006 Nalbuphine (Nubain) - Use During Labor and Delivery
1/3/2006 Fraudulent Avian Flu Therapies - Potentially harmful or 5/interfere with conventional treatments
12/15/2005 Methotrexate Injection From Bedford Recalled Due to Ethylene Glycol Content
12/13/2005 Clarithromycin (Biaxin/Biaxin XL)- study shows increased cardiovascular mortality
12/8/2005 Paxil and Paxil CR - updated Pregnancy Precautions
12/2/2005 Epoetin Alfa (Epogen®/Procrit®) and Darbepoetin Alfa (Aranesph®) - Associated with Pure Red Cell Aplasia
12/2/2005 MBI Ordered to Cease Manufacturing and Distributing Products
12/2/2005 Alemtuzumab (Campath) Associated with Severe Idiopathic Thrombocytopenic Purpura in Multiple Sclerosis Trials
12/2/2005 Recombinant Factor VIIa (NovoSeven) - Increased Risk of Arterial Thromboembolic Events
11/23/2005 Tamsulosin (Flomax) Associated with Intraoperative Floppy Iris Syndrome
11/23/2005 GenTeal Gel and GenTeal GelDrops Artificial Tears Recall (Novartis Ophthalmics)
11/18/2005 Long-Acting Beta 2-Agonists Can Increase Severe Asthma Episodes
11/15/2005 Ortho Evra: higher estrogen exposure than oral contraceptives
11/15/2005 Alefacept (Amevive) not recommended for HIV patients
11/4/2005 Morphine Extended Release (Avinza) - Alcohol 5/cause dose-dumping
11/3/2005 Ibritumomab tiuxetan (Zevalin) and Rituximab (Rituxan) - Potentially-fatal Skin and Mucus Membrane Reactions
10/28/2005 Pemoline Products Withdrawn from Market due to Risk of Liver Toxicity
10/18/2005 Duloxetine (Cymbalta®) 5/Exacerbate Hepatic Injury in Patients with Preexisting Liver Disease
10/4/2005 Guillain Barre Syndrome associated with meningococcal conjugate vaccine
10/3/2005 Atomoxetine (Strattera) - Increased Risk of Suicidal Ideation in Pediatric Patients
9/28/2005 Paxil and Paxil CR - updated Pregnancy Precautions
9/28/2005 Toprol-XL (metoprolol succinate) extended release tablets name confusion
9/16/2005 NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection/[rDNA origin]) NovoLog (insulin aspart [rDNA origin] injection) - Change in Packaging to Help Prevent Dispensing Errors
9/15/2005 Cetuximab (Erbitux) - Additional Monitoring for Electrolyte Abnormalities and Infusion Reactions
9/9/2005 Kaopectate - Reformulation (updated)
9/6/2005 Hepatitis B Vaccine Products Stocked in the Pharmacy
9/6/2005 Trastuzumab (Herceptin) Increases Risk of Cardiotoxicity
8/17/2005 Accutane and Generic Isotretinoin: New risk management program - iPLEDGE
8/4/2005 Recall of Perrigo Infant Drops containing Acetaminophen/Dextromethorphan/or Pseudoephedrine
7/20/2005 Efalizumab (Raptiva) associated with hemolytic anemia/thrombocytopenia/and serious infection
7/20/2005 UPDATE - Mifepristone (Mifeprex/RU-486) associated with serious infection and bleeding
7/20/2005 New Guidelines For Appropriate Nesiritide Use
7/14/2005 Hydromorphone Extended Release (Palladone) withdrawn for safety reasons
7/12/2005 Erectile Dysfunction Drugs and Vision Loss
7/12/2005 Fentanyl Boxed Warnings
7/7/2005 Eli Lilly Discontinuing Humulin U Ultralente/Humulin L Lente/Regular Iletin II/and NPH Iletin II Insulin Products
7/1/2005 Antidepressants and Suicidality in Adults to be Evaluated
6/17/2005 Gefitinib (Iressa) - shows no survival benefit for non-small cell lung cancer/use discouraged.
6/16/2005 COX-2 Selective Inhibitors and NSAIDs - Patient Medication Guide Requirement
6/13/2005 Efavirenz (Sustiva) - Pregnancy Risk has Changed to Category D (positive evidence of fetal risk).
6/6/2005 Children's Tylenol Meltaways 80 mg/Children's Tylenol SoftChews 80 mg/and Junior Tylenol Meltaways 160 mg - recalled due to confusing packaging and labeling
5/25/2005 Dextromethorphan abuse associated with death
5/25/2005 Mitoxantrone (Novantrone) - Cardiotoxicity and Secondary Acute Myelogenous Leukemia (AML) in Patients with Multiple Sclerosis
5/25/2005 Able Laboratories Inc. - Recalls All Products/Suspends Manufacturing
5/20/2005 Nesiritide 5/adversely effect short-term survival and kidney function in patients with decompensated heart failure
5/20/2005 Albumin considered safe for use in critically ill patients
5/20/2005 Pamidronate and Zoledronic acid - reports of jaw osteonecrosis - UPDATED
4/29/2005 Drotrecogin alfa (Xigris) Not Effective in Pediatric Patients with Severe Sepsis
4/25/2005 Promethazine (Phenergan) injection classified as vesicant
4/25/2005 Oxcarbazepine (Trileptal) 5/cause serious skin and multiorgan hypersensitivity reactions
4/25/2005 Interferon beta-1b (Betaseron) 5/cause hepatotoxicity
4/25/2005 Galantamine brand name changed to Razadyne
4/12/2005 Atypical Antipsychotics - increased mortality in elderly patients with dementia
4/7/2005 Adverse Effects of NSAIDs - Valdecoxib withdrawn/labeling changes for all NSAIDs
4/5/2005 Galantamine (Reminyl) - possible increased mortality in patients with mild cognitive impairment
3/31/2005 Nefazodone 50 mg/100 mg/150 mg/200 mg/and 250 mg Tablets Recall (Ivax Pharmaceuticals)
3/23/2005 Changes to CII prescribing - Postdating no longer allowed
3/22/2005 Gabapentin 100 mg capsules (Neurontin) - Recall
3/18/2005 Xigris 5/increase mortality in single organ dysfunction patients
3/17/2005 Interferon beta-1a (Avonex) - Reports of serious hepatic injury
1/24/2006 Potential Cancer Risk With Topical Pimecrolimus (Elidel) and Tacrolimus (Protopic)
3/10/2005 Bisphosphonate-Induced Renal Dysfunction in Oncology Practice
3/3/2005 Rosuvastatin (Crestor) - Myopathy and Rhabdomyolysis in Asian-Americans at 40 mg Dose
3/2/2005 Drug Storage Changes - Date All Multidose Vials
2/23/2005 Tiagabine (Gabitril) can cause seizures in patients without epilepsy
2/18/2005 Promethazine and Fatal Respiratory Depression In Children Under Age 2 - Use Contraindicated
2/17/2005 Changes to CII prescribing - FAQ
2/10/2005 Methylphenidate hydrochloride 2.5 mg/5 mg/and 10 mg Chewable Tablets (Methylin CT) - Recall Update
2/10/2005 Saquinavir (Fortovase/Invirase) plus Ritonavir (ritonavir boosted saquinavir) interacts with rifampin - increased liver toxicity reported
2/10/2005 Anagrelide (Agrylin) exposure increased in patients with hepatic impairment/contraindicated in severe hepatic impairment
2/10/2005 Name confusion with Zyprexa (olanzapine) and Zyrtec (cetirizine HCl)5/lead to medication errors
2/10/2005 Amphetamine/Dextroamphetamine (Adderall/Adderall XR)associated with sudden death/sales suspended on Canadian market
1/20/2005 Nevirapine (Viramune®) - Risk factors for liver toxicity
1/20/2005 Methylphenidate hydrochloride 5 mg Chewable Tablet (Methylin CT) - Recall
1/20/2005 Changes to CII prescribing - Postdating no longer allowed
1/14/2005 Aranesp (darbepoetin alfa) and Adverse Effects with Off-Label Dosing
1/13/2005 Amiodarone hydrochloride tablets (Cordarone®/generic) - Patient Medication Guide Requirement
1/5/2005 Avastin (bevacizumab) increased risk of arterial thromboembolic events - Update
12/22/2004 Infliximab (Remicade) associated with hepatotoxicity
12/22/2004 Atomoxetine (Strattera) associated with liver toxicity
12/21/2004 Naproxen (Aleve/Anaprox/Naprelan/Naprosyn) cardiovascular risk
12/21/2004 Celecoxib (Celebrex) cardiovascular risk
12/14/2004 Valdecoxib (Bextra®) cardiovascular risk and severe skin reactions
12/1/2004 Penicillin G benzathine/Penicillin G procaine (Bicillin C-R) and Penicilln G benzathine (Bicillin L-A) - Inappropriate Use for Syphilis
11/22/2004 Medroxyprogesterone acetate injection (Depo-Provera® Contraceptive Injection) associated with bone mineral density loss
11/17/2004 Mifepristone (Mifeprex/RU-486) associated with serious infection and bleeding
11/9/2004 Adalimumab (Humira) and infections/hypersensitivity/and hematologic reaction
10/15/2004 Antidepressants and suicidality in children: FDA requests labeling change
10/15/2004 Tumor Necrosis Factor (TNF) α Blocking Agents - Increased Risk of Lymphoma and Other Malignancies
10/11/2004 Rituximab and Hepatitis
10/6/2004 Levoxyl (levothyroxine)
10/1/2004 Pamidronate and Zoledronic acid - reports of jaw osteonecrosis
9/30/2004 Rofecoxib (Vioxx®) withdrawn due to cardiovascular risk
9/27/2004 Pantoprazole (Protonix) I.V. glass vial breakage
9/2/2004 Shipment of Chiron's Influenza Virus Vaccine (Fluvirin) Delayed
9/1/2004 Atypical antipsychotics and hyperglycemia
8/25/2004 Infliximab (Remicade) new hematologic side effects warnings
8/19/2004 Lantus (insulin glargine [rDNA origin] injection recall Lot 40D024/Lot 40D025/Lot 40D027)
8/17/2004 Enoxaparin (Lovenox) adjust dose for severe renal impairment
8/11/2004 Altocor® (lovastatin extended release) withdrawal/replaced by Altoprev®
7/6/2004 Antidepressant labeling changes
5/14/2004 Motrin/Children's chewable
5/12/2004 Trazodone interactions with CYP3A4 inhibitors & carbamazepine
5/5/2004 Seroquel (quetiapine) 25 mg tablet recall Lot 3446J
4/28/2004 Tegaserod Maleate (Zelnorm®)
4/28/2004 Kaopectate - Reformulation
4/27/2004 Dulcolax Products - not all formulations contain bisacodyl
4/16/2004 hormone replacement therapy update
4/6/2004 Duragesic Patch Recall UPDATE
4/6/2004 Human rabies vaccine (Imovax - Aventis Pasteur)
2/23/2004 Duragesic Patch Recall
2/2/2004 Viramune (nevirapine)
12/2003 Ziprasidone and fluoroquinolones.
12/30/2003 Ephedra
11/21/2003 Arava (leflunomide)
11/21/2003 Ultane (sevoflurane)
10/10/2003 Morphine sulfate oral solutions
10/3/2003 FD&C Blue No. 1 Toxicity
9/10/2003 Orlaam® (levomethadyl hydrochloride acetate)
9/3/2003 Actiq lozenges
8/28/2003 Zenapax (daclizumab)
7/31/2003 Lamivudine/Abacavir and Tenofovir
7/2003 norethindrone and ethinyl estradiol tablets (Nortrel)
4/2003 risperidone (Risperdal® - Janssen Pharmaceutical/Inc.)
2/25/2003 pergolide mesylate (Permax)
2/3/2003 Dolasetron (Anzemet)
2/3/2003 Granisetron (Kytril)
2/3/2003 Ondansetron (Zofran)
1/30/2003 OneTouch® Test Strips
1/30/2003 SureStep® Test Strips
1/10/2003 Premarin/Prempro/and Premphase
11/13/2002 Valdecoxib (Bextra)
10/28/2002 meningococcal polysaccharide vaccine
10/14/2002 medroxyprogesterone acetate & estradiol cypionate injectable suspension (Lunelle™)
10/04/2002 mefloquine (Lariam®)
5/20/2002 (IGIV) Intravenous Immune Globulin
1/2002 droperidol (Inapsine)