What's New

• Tysabri (Natalizumab): Update of Healthcare Professional Information 
  Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri. Posted 02/05/2010
• Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical 
  Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death. Posted 02/04/2010
• FDA Patient Safety News Video Broadcasts 
  February 2010 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Posted 02/03/2010
• Zyprexa (olanzapine): Use in Adolescents 
  Clinicians should consider the potential long-term risks when prescribing to adolescents. Posted 01/29/2010
• Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension 
  Risk information added to Warnings/Precautions section and data summary provided. Posted 01/29/2010
• Edwards Lifesciences Aquarius Hemodialysis System: Recall 
  Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm. Posted 01/28/2010
• Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall 
  Plastic centrifuge rotor may crack, break apart and be forcefully ejected. Posted 01/28/2010
• Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall 
  Class I recall due to "coring" or dislodging of silicone cores or slivers from the ports into which they are inserted. Posted 01/26/2010
• Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment 
  Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored. Posted 01/26/2010
• Alli 60 mg capsules (120 count refill kit): Counterfeit Product 
  UPDATE [01/23/2010] Previous alert updated with information on laboratory analysis of sibutramine levels in counterfeit product-Product sold over the internet contains controlled substance sibutramine. Posted 01/18/2010
• Nipro GlucoPro Insulin Syringes: Recall 
  Needles may become detached and remain in the skin. Posted 01/22/2010
• Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review 
  Contraindication to use in patients with history of cardiovascular disease. Posted 01/21/2010