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MedWatch Safety Alert RSS Feed FDA MedWatch Safety Alerts http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xml en-us Fri, 25 May 2012 13:20:00 -0500 jay.wattenberg@fda.hhs.gov (Jay Wattenberg) FDA MedWatch http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm052224.gif http://www.fda.gov/Safety/MedWatch/default.htm 144 52 FDA MedWatch Safety Alerts Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software: Class I Recall - Potential Dosing Errors Problems associated with mix-ups related to salt-based or ion-based ordering of electrolytes. Fri, 25 May 2012 13:20:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305762.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305762.htm Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors Risk of elevated bicarbonate levels in patients undergoing hemodialysis, which can contribute to metabolic alkalosis, a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. Fri, 25 May 2012 09:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm Franck’s Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall Recall of all products sold by Franck's since November 2011 due to the possibility of lack of sterility. Thu, 24 May 2012 21:20:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305592.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305592.htm Hospira Carpuject Pre-filled Cartridges - Drug Alert: Products May Contain More Than the Intended Fill Volume Healthcare professionals should visually inspect and confirm that the cartridge contains the labeled fill volume before dispensing and again before administering to patients. Wed, 23 May 2012 08:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305236.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305236.htm West Coast Nutritionals Dietary Supplement Products: Recall - Undeclared Drug Ingredient Products marketed as dietary supplements contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Mon, 21 May 2012 08:30:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304775.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304775.htm Zithromax (azithromycin): FDA Statement on risk of cardiovascular death A retrospective cohort study reports small increase in risk of cardiovascular deaths and risk of all cause deaths associated with 5 day course of antibiotic drug Thu, 17 May 2012 13:45:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose UPDATED 05/14/2012. New recommendations for monitoring patients, and new contraindications, and dosing & administration information for use in certain patients. Mon, 14 May 2012 12:30:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284355.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284355.htm Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse. Mon, 14 May 2012 12:05:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304044.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304044.htm Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies UPDATED 05/07/2012. Increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma in patients being treated with Revlimid. Mon, 07 May 2012 12:20:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250606.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250606.htm Certain Compounded Drugs from Franck's: FDA Issues Second Warning to Physicians [UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation. Fri, 04 May 2012 10:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301137.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301137.htm Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug Interactions UPDATED 04/26/2012. Label revised to state that co-administration of Victrelis with certain ritonavir-boosted human immunodeficiency virus protease inhibitors is not recommended. Originally posted 02/09/2012 Thu, 26 Apr 2012 13:45:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291144.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291144.htm X-Rock: Recall - Undeclared Drug Ingredient Undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Wed, 25 Apr 2012 07:50:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301621.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301621.htm Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result Customers should immediately discontinue use of any affected product. Tue, 24 Apr 2012 11:15:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301483.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301483.htm Brilliant Blue G Compounded by Franck's: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases [UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation. Fri, 20 Apr 2012 12:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm296383.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm296383.htm Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication Risk of renal impairment, hypotension, and hyperkalemia with concomitant use of aliskiren with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes. Fri, 20 Apr 2012 10:38:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301120.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301120.htm Other‐Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial Contamination Exposure to contaminated product may lead to serious infections. Wed, 18 Apr 2012 12:30:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume Consequences of opioid pain medication overdose can be life-threatening, including respiratory depression (slowed breathing or suspension of breathing), and low blood pressure. Wed, 18 Apr 2012 08:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300852.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300852.htm Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use. Tue, 10 Apr 2012 11:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm299605.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm299605.htm Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform May result in reduction of blood flow from the pump, pump/graft thrombosis, or perforation of the outflow graft. Wed, 04 Apr 2012 15:45:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298710.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298710.htm Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient The counterfeit product may have resulted in patients not receiving needed therapy. Tue, 03 Apr 2012 16:15:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298583.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298583.htm