What's New

• Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review 
  FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo. Posted 11/20/2009
• Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication 
  Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use. Posted 11/19/2009
• Vicks Sinex Nasal Spray - Recall 
  Product found containing the bacteria B. cepacia. Posted 11/19/2009
• RockHard Weekend - product contains undeclared drug ingredient 
  Recall of product, sold as a dietary supplement, containing undeclared sulfoaildenafil. Posted 11/18/2009
• Cardiovascular Systems ViperSheath Sheath Introducer - Recall 
  Nationwide recall due to stretching or fracture of the sheath during use. Posted 11/17/2009
• IDS Sports Dietary Supplements - Recall 
  Five products marketed as dietary supplements contain undeclared substances considered to be steroids. Posted 11/17/2009
• Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction 
  Effectiveness of clopidogrel is reduced when taken with omeprazole, placing patients who use clopidogrel to prevent blood clots at risk for heart attacks or strokes if they are also taking omeprazole. Posted 11/17/2009
• Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification 
  Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT. Posted 11/16/2009
• Pai You Guo, Marketed as Dietary Supplement - Recall 
  Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein. Posted 11/13/2009
• Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis 
  Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices. Posted 11/13/2009
• Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen 
  Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions. Posted 11/13/2009
• Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall 
  Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device. Posted 11/12/2009
• External Biphasic Defibrillators Energy Levels: Initial Communication 
  14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient. Posted 11/10/2009
• Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall 
  Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery. Posted 11/09/2009
• Hospira Brand Propofol and Liposyn Products - Recall 
  Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow. Posted 11/09/2009
• Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall 
  [UPDATED 11/06/2009] Recall classified as Class I. Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Posted 10/30/2009
• Stiff Nights - product contains undeclared drug ingredient 
  Consumers warned that product sold as a dietary supplement contains sulfoaildenafil. Posted 11/05/2009
• Centurion Medical Products - Premie Pack and Meconium Pack - Recall 
  Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label. Posted 11/04/2009
• Dietary Supplements Sold on Internet by Bodybuilding.com 
  Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury. Posted 11/03/2009
• Unomedical Manual Pulmonary Resuscitator - Recall 
  [UPDATED 11/03/2009] Recall classified as Class I
• FDA Patient Safety News Video Broadcasts 
  November 2009 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Posted 11/03/2009