What's New Archive Since May 2009

• Byetta (exenatide) - Renal Failure 
  Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta. Posted 11/02/2009
• Cordis CROSSOVER Sheath Introducer - Recall 
  Nationwide recall due to stretching or fracture of the sheath during use. Posted 10/30/2009
• Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall 
  Nationwide recall of all lots of product due to potential for needle to become detached from syringe during use. Posted 10/27/2009
• Peramivir IV 
  Investigational antiviral drug approved for emergency use in H1N1 influenza infection; mandatory reporting of adverse events required by healthcare providers. Posted 10/24/2009, UPDATED 10/30/2009
• Rituxan (rituximab) - PML 
  Third case of PML reported, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist. Posted 10/23/2009
• Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall 
  Nationwide recall due to the potential for particulate matter in conjunction with crystallization in the product. Posted 10/21/2009
• September 2009 
  Monthly Safety Labeling Changes - Summary of revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, PPI/Medication Guide sections of drug Prescribing Information. Posted 10/19/2009
• Medical Device Power Cords Safety Investigation: Initial Communication 
  Reports of sparking, charring, and fires from device power cords. Posted 10/19/2009
• Tamiflu (oseltamivir) for Oral Suspension 
  [UPDATED 10/16/2009] Consumers warned of unapproved and illegal H1N1 drug products purchased over the internet.
• Unapproved Drugs: Enforcement Actions 
  FDA directed four companies to stop making and distributing 30 mg and 60 mg codeine sulfate tablets that lack the required FDA approval. Posted 10/16/2009
• Dexferrum (iron dextran injection) - Labeling Change 
  Risk of anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. Posted 10/16/2009
• Relenza (zanamivir) Inhalation Powder 
  Drug must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator. Posted 10/09/2009
• CT Brain Perfusion Scans Safety Investigation: Initial Notification 
  Initial Notification of risk of radiation overexposures during CT brain perfusion scans. Posted 10/09/2009
• Unomedical Manual Pulmonary Resuscitator - Recall 
  Recall due to malfunction which impairs ability of device to generate positive pressure necessary to function properly. Posted 10/07/2009
• Philips Heartstart Fr2+ Automated External Defibrillators - Recall 
  Nationwide recall due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. Posted 10/05/2009
• Neuron 6F 070 Delivery Catheter [Penumbra] 
  Reports that the catheter could kink or ovalize and lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Posted 10/01/2009
• Heparin: Change in Reference Standard 
  The change will result in 10% reduction in the potency of the heparin marketed in the U.S. Posted 10/01/2009
• Neocate Infant Specialized Formula - Recall 
  Nationwide recall of Neocate Infant Specialized Formula, Lot # P91877, due to a manufacturing error that resulted in protein levels lower than that declared on the label. Posted 09/29/2009
• Tamiflu (oseltamivir) for Oral Suspension 
  [UPDATED 09/25/2009] New links added. Originally posted 09/24/2009
• Children's and Infants' Tylenol Oral Suspension Products - Recall 
  Voluntary recall because of potential manufacturing problems. Posted 09/25/2009
• Exjade (deferasirox) - Early Communication 
  Early Communication describing an increased number of adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS). Posted 09/25/2009
• Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis 
  Cases of acute pancreatitis reported in patients treated with sitagliptin. Posted 09/25/2009
• Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit 
  Class I Recall due to possibility of obstruction or disruption of therapy. Posted 09/24/2009
• Tamiflu (oseltamivir) for Oral Suspension 
  Risk of medication dosing errors reported. Posted 09/24/2009
• Natalizumab (marketed as Tysabri) 
  FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Posted 09/17/2009
• Promethazine Hydrochloride Injection 
  Boxed Warning added to labeling, describing risks of severe tissue injury, including gangrene, following intravenous administration of promethazine. Posted 09/16/2009
• LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc) 
  Class I recall due to failure or delay in delivery of therapy. Posted 09/16/2009
• Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) 
  Nationwide recall due to risk of obstruction and inability to ventilate patient. Posted 09/11/2009
• Covidien Pedi-Cap End-Tidal CO2 Detector 
  Class I recall because the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation. Posted 09/10/2009
• ConMed Linvatec - Universal Cables and Power Pro Handpieces 
  Class 1 recall due to risk of powered device self-activation and injury to patient or surgical staff. Posted 09/10/2009
• Albuterol Sulfate Inhalation Solution unit-dose vials (Dey LP brand) 
  Two lots (35,760 cartons) stolen in Texas. Pharmacies encouraged to verify pedigree documentation for all purchases of Dey-labeled Albuterol. Posted 09/10/2009
• Penumbra Neuron 5F Select Catheter 
  Class 1 recall due to defect which may result in brain blood clot and blood vessel puncture. Posted 09/09/2009
• Philips Avalon Fetal Monitors 
  Safety alert issued due to complaints of inaccurate output readings that may lead to failure to identify fetal distress. Posted 09/04/2009
• Myfortic (mycophenolic acid) 
  Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. Posted 09/03/2009
• Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009 
  [UPDATED 08/31/2009] Supplemental Q&As added (increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents). Original posting 08/04/2009
• FDA Patient Safety News Video Broadcasts 
  September 2009 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Posted 08/31/2009
• Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) 
  [UPDATED 08/28/2009] Leukotriene inhibitors to be labeled with warnings for neuropsychiatric events. Posted 6/12/2009
• Intelence (etravirine) 
  Reports of severe, potentially life-threatening and fatal skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and hypersensitivity reactions. Posted 08/27/2009
• Levemir Insulin (Novo Nordisk) 
  [UPDATED 08/26/2009] Stolen vials of Levemir still may be on the market. FDA received multiple reports of patients who suffered adverse events due to poor control of glucose levels after using vial from stolen lots. Posted 06/13/2009
• Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom] 
  [UPDATED 08/25/2009] Voluntary recall classified as Class 1 due to the reasonable probability that use of these products will cause serious injury or death. Posted 07/22/2009
• Steam Dietary Supplement 
  [UPDATED] Nationwide recall expanded, new lot added due to undeclared drug ingredient. Posted 08/24/2009
• Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review 
  FDA is reviewing reports of serious liver injury, including liver failure. Posted 08/24/2009
• Accusure Insulin Syringes [31G, 1/2 cc and 1 cc] 
  Nationwide recall due to potential for needle to detach from syringe, become stuck in the vial, push back into syringe, or remain in skin after injection. Posted 08/24/2009
• Ibuprofen (Unapproved) topical drug products 
  The agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. [08/21/2009]
• Hospira, Inc. Device Recall 
  Potential risks from Hospira, Inc. devices power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Posted 08/17/2009
• Dextroamphetamine, Amphetamine 20mg Tablets 
  Recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets. Posted 08/14/2009
• CellCept (mycophenolate mofetil) August 2009 
  Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. Posted 08/14/2009
• GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology 
  Possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. Posted 08/13/2009
• Nuby Gel Filled, Cottontails, and Playschool Teethers 
  Nationwide recall due to potential bacterial contamination, placing children with weakened immune systems at risk of harm. Posted 07/18/2009
• July 2009 
  Monthly Safety Labeling Changes - Summary of revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, PPI/Medication Guide sections of drug Prescribing Information. Posted 08/12/2009
• Alaris System (Cardinal Health) 
  Class 1 recall due to potential for patients experiencing under- or over-infusion, which may result in serious injury or death. Posted 08/05/2009
• Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009 
  FDA notified healthcare professionals of an update to the Boxed Warning describing an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers. Posted 08/04/2009
• FDA Patient Safety News Video Broadcasts 
  August 2009 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Posted 08/04/2009
• Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) 
  [UPDATED] FDA announced changes to the established drug names to reinforce individual potencies and prevent medication errors, and provided recommendations for healthcare professionals to consider, plus information for patients, family members, and...
• POWERSAIL Coronary Dilatation Catheters 
  Class 1 recall due to damage to distal catheter shaft and risk of air embolism and myocardial infarction. Posted 07/30/2009
• Colchicine (marketed as Colcrys) 
  Two previously uncharacterized safety concerns associated with the use of colchicine. Posted 07/30/2009
• Body Building Products (Marketed as Containing Steroids or Steroid-like Substances) 
  Products are unapproved drugs and associated with serious risks of liver injury, stroke. Posted 07/28/2009
• Electronic Cigarettes 
  FDA analysis has found carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. Posted 07/22/2009
• Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom] 
  Nationwide recall due to potential risk of fire and burns for patient and caregiver. Posted 07/22/2009
• Nuby Gel Filled, Cottontails, and Playschool Teethers 
  Nationwide recall due to potential bacterial contamination, placing children with weakened immune systems at risk of harm. Posted 07/18/2009
• Weight Loss Products by Young You Corporation 
  Products recalled due to an undeclared drug ingredient which may present a significant health risk for patients with history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 07/17/2009
• Propofol Injectable Emulsion, 10 mg/mL 100 mL vials 
  Recall due to presence of elevated endotoxin levels in some vials. Posted 07/17/2009
• Omalizumab (marketed as Xolair) - Early Communication about an Ongoing Safety Review 
  FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events. Posted 07/16/2009
• Nature & Health Co. supplement products: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac 
  Male enhancement products recalled because samples were found to contain undeclared drug ingredients. Posted 07/16/2009
• Concentrated Acetaminophen Drops 
  Nationwide recall of all lots of Brookstone Pharmaceuticals' Concentrated Acetaminophen Drops in 16 oz (473 ml) bulk containers, a cautionary measure to minimize any confusion and potential risk to patients from dosing errors. Posted 07/15/2009
• Libipower Plus 
  Product recalled because samples were found to contain an undeclared drug ingredient. Posted 07/14/2009
• Immunosuppressant Drugs: Required Labeling Changes 
  FDA requiring manufacturers of immunosuppressant drugs to update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy. Posted 07/14/2009
• Medtronic Paradigm Quick-Set Infusion Sets 
  Nationwide recall because the affected infusion sets may not allow the insulin pump to vent air pressure properly, resulting in the device delivering too much or too little insulin, potentially leading to serious injury or death. Posted 07/13/2009
• Mallinckrodt Sodium Chromate Cr-51 Injection 
  Recall of product due to subpotency and possibility of misdiagnosis or delayed diagnosis. Posted 07/10/2009
• June 2009 
  Monthly Safety Labeling Changes -Summary of revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS,PPI/Medication Guide sections of drug Prescribing Information. Posted 07/09/2009
• BiPAP Focus Non-Invasive Ventilator System, Respironics California 
  Class I Recall due to power supply failures that have occurred on some ventilators. Posted 07/09/2009
• Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement: Vital Pharmaceuticals Inc 
  Nationwide recall because of the potential for contamination with Salmonella. Posted 07/09/2009
• Propoxyphene-containing Products 
  FDA taking actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. Posted 07/07/2009
• Arthroscopic Shavers: Ongoing Safety Review 
  Reports submitted to FDA describing instances of tissue remaining within certain arthroscopic shavers, even after the cleaning process was believed to have been completed. Posted 07/07/2009
• Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) 
  FDA requires new Boxed Warnings and patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms. Posted 07/01/2009
• Lantus (insulin glargine) 
  FDA reviewing safety data regarding possible risk for cancer in patient with diabetes. Posted 07/01/2009
• FDA Patient Safety News Video Broadcasts 
  July 2009 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. (Posted 07/01/2009)
• FDA Drug Safety Newsletter 
  Information for healthcare professionals about the findings of selected postmarketing drug safety reviews from FDA, as well as information on important emerging drug safety issues and recently approved new molecular entities. Posted 06/26/2009
• Nestle Toll House Prepackaged, Refrigerated Cookie Dough 
  FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Posted 06/20/2009
• Stamina-Rx Dietary Supplement Products 
  Nationwide recall due to analysis of Stamina-Rx samples found to contain undeclared ingredient benzamidenafil, a Phosphodiesterase Type 5 inhibitor. Posted 06/19/2009
• Cefepime (marketed as Maxipime) Update of Ongoing Safety Review 
  FDA finished its analysis of a possible risk of higher death with cefepime and has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Posted 06/17/2009
• Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size) 
  Reports of permanent loss of sense of smell with use of these nasal gel or swab products. Posted 06/16/2009
• Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review 
  FDA perspective on study data published about the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder in children. (Posted 06/15/2009)
• Levemir Insulin (Novo Nordisk) 
  Patients advised to check personal supply of insulin to identify possible stolen and dangerous product. Posted 06/13/2009
• Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) 
  [UPDATED 08/28/2009] Leukotriene inhibitors to be labeled with warnings for neuropsychiatric events. Posted 6/12/2009
• Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers 
  Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components. Posted 06/11/2009
• Sirolimus (marketed as Rapamune) 
  Clinical trial data suggests increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus. Posted 06/11/2009
• Skin Products Made by Clarcon 
  Skin sanitizers and skin protectants recalled because of high levels of disease-causing bacteria found in the products. Posted 06/09/2009
• Propylthiouracil 
  Risk of serious liver injury, including liver failure and death, associated with the use of propylthiouracil in adult and pediatric patients. Posted 06/04/2009
• Simponi (golimumab) 
  Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009
• Fun Express Water-based Face Paints for Children 
  UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint) (Updated 05/26/2009)
• Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003 
  Class I recall issued because the monitors may fail to sound an alarm. (Posted 05/18/2009)
• Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand) 
  UPDATE - Recall due to variance in amount of active ingredient. (UPDATED 05/12/2009)
• Tarceva (erlotinib) May 2009 
  Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration. (Posted 05/08/2009)
• Biosite brand Triage Cardiac Panel 
  Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis. (Posted 05/08/2009)
• Testosterone gel products (AndroGel 1% and Testim 1% ) 
  Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone. (Posted 05/07/2009)