MedWatch Safety Alerts, Jan 01 - Dec 31 2012

• 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 (Posted 5/17/12)
• April Safety Labeling Changes Monthly Safety Labeling Changes includes 43 products with revisions to Prescribing Information. Posted 05/14/2012
• 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. Originally posted 12/20/2011
• 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. Posted 05/14/2012
• 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. Originally posted 04/08/2011
• 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. Posted 03/19/2012
• 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. Posted 04/20/2012
• 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
• 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. Posted 04/25/2012
• 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. [Posted 4/24/12]
• 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. Posted 04/20/2012
• Other‐Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial Contamination Exposure to contaminated product may lead to serious infections. Posted 04/18/2012
• 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. Posted 04/18/2012
• March 2012 Monthly Safety Labeling Changes includes 39 products with revisions to Prescribing Information. Posted 04/12/2012
• 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. [Posted 4/10/12]
• 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.
• Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient The counterfeit product may have resulted in patients not receiving needed therapy. [Posted 04/03/2012]
• Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms Revised drug label clarifying dosing and warning recommendations. Posted 03/28/2012
• Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall - Potential for Visible Particulates Risk of embolization/infarction to organs and potential organ complications. Posted 03/23/2012
• 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. Posted 03/19/2012
• February 2012 Monthly Safety Labeling Changes includes 65 products with revisions to Prescribing Information. Posted 03/15/2012
• Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, Mercury Products with this toxic metal have been found in at least seven states, are manufactured abroad and often sold in shops in Latino, Asian, African or Middle Eastern neighborhoods and online. Posted 03/15/2012
• Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall - Potential For Balloon To Not Deflate Or To Deflate To Slowly Prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient. Posted 03/13/2012
• Gerber Good Start Gentle Powdered Infant Formula: Recall - Off-Odor Reports of gastrointestinal complaints. Posted 03/09/2012
• Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Component Unexpected component failure may lead to AEDs not delivering defibrillation therapy, causing serious adverse health consequences, including death. Posted 03/02/2012
• Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk of myopathy, kidney damage, and kidney failure, which can be fatal. Posted 03/01/2012
• Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator: Class I Recall – Cable May Cause an Electrical Shortage That can Cause Ventilators to Shutdown Unexpectedly Customers should stop using the alarm cable [Posted: 02/28/2012]
• Statin Drugs - Drug Safety Communication: Class Labeling Change New adverse event and liver enzyme monitoring information in statin labels and updated drug interactions information in lovastatin label. [Posted 2/28/12]
• Regenerect: Recall - Undeclared Drug Ingredient UPDATED 02/27/2012. Product marketed as dietary supplement contain drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Originally posted 05/02/2011
• Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen Women may be left without adequate contraception, and at risk for unintended pregnancy. Posted 02/27/2012
• Nemschoff Chairs Perinatal Pediatric Hospital Bed (Bassinet): Class 1 Recall - Risk of Injury to Patients Doors and drawers may inadvertently open while bassinet is in motion; product may be difficult to maneuver due to it swivel caster configuration. Posted 02/24/2012
• Cytarabine for Injection, 1 gm/vial [Bedford Labs]: Recall: Risk of Lack of Sterility Providers should not use the product lots listed for patient care and should immediately quarantine any product for return [02/23/2012]
• American Regent Injectable Products: Recall - Visible Particulates in Products UPDATED 04/04/2012. Cyanocobalamin Injection, USP, (1000 mcg/mL), 1mL Vial (Lot# 1662,1679 and 1683) recalled.
• Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes: Class 1 Recall - Inadvertent Dislodgement Difficulty disconnecting accessories from the tube may result may result in dislodgement of tube and could lead to serious patient injury or death [Posted 02/23/2012]
• CareFusion Cortical Stimulator Control Unit: Class 1 Recall - Software Malfunction and Short Circuit Affects device and software that aids in the identification and mapping of areas of the brain. Posted 02/23/2012
• Healthy People Co. Dietary Supplements: Recall - Undeclared Drug Ingredient UPDATED 02/22/2012. Recall expanded to include all lots purchased on or before October 25, 2011. Originally posted 02/06/2012
• Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints Reports of dosing syringe flow restrictor being pushed into the bottle when inserting the syringe. Posted 02/17/2012
• Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries Brush head may break off in the user’s mouth or near the face, causing cuts to the mouth and gums, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes. Posted 02/16/2012
• Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy. Posted 02/14/2012
• Cytarabine for Injection, 1 gm/vial [Bedford Labs]: Recall: Risk of Lack of Sterility Providers should not use the product lots listed for patient care and should immediately quarantine any product for return [02/23/2012]
• Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes: Class 1 Recall - Inadvertent Dislodgement Difficulty disconnecting accessories from the tube may result may result in dislodgement of tube and could lead to serious patient injury or death [Posted 02/23/2012]
• American Regent Injectable Products: Recall - Visible Particulates in Products UPDATED 04/04/2012. Cyanocobalamin Injection, USP, (1000 mcg/mL), 1mL Vial (Lot# 1662,1679 and 1683) recalled.
• Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy: Class I Recall - Humidifier Lids Fail to Pop Off at the Intended Pressure The humidifier can leak and can potentially interrupt the flow of supplemental oxygen to the patient. Posted 02/14/2012
• January 2012 Monthly Safety Labeling Changes includes 63 products with revisions to Prescribing Information. Posted 02/13/2012
• RegenArouse: Recall - Undeclared Drug Ingredient Product marketed as dietary supplement contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 02/13/2012
• Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or Effective Products could potentially expose users and patients to unnecessary and potentially harmful X-rays. Posted 02/10/2012
• Wholistic Herbs, Inc. "Koff and Kold" and "Kold Sore" Spray: Recall - Non-Sterile Products Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. Also, nasal solutions that are not sterile could lead to a respiratory infection. Posted 02/10/2012
• 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
• Proton Pump Inhibitors (PPIs) - Drug Safety Communication: Clostridium Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs Symptoms may include watery stool, abdominal pain, and fever. Patients may go on to develop more serious intestinal conditions. Posted 02/08/2012
• H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination UPDATED 02/08/2012. NAR Surgical Crichothyroidotomy (Crickit) Kits recalled. Use of contaminated Povidone Prep Pads could lead to life-threatening infections. Originally posted 03/18/2011
• Healthy People Co. Dietary Supplements: Recall - Undeclared Drug Ingredient UPDATED 02/22/2012. Recall expanded to include all lots purchased on or before October 25, 2011. Originally posted 02/06/2012
• Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up During packaging and labeling, tablets from one product type may have carried over into packaging of another product. Posted 02/03/2012
• Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Posted 02/03/2012
• Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Posted 02/01/2012
• Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia). Posted 01/31/2012
• Treanda (bendamustine HCL): Recall - Particulate Matter in Vial Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage. Posted 01/30/2012
• Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. Posted 01/20/2012
• Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms. Posted 01/20/2012
• Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination Possibility of an adverse reaction or unknown drug-drug interaction. Posted 01/20/2012
• Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity New Boxed Warning and Contraindication highlighting these risks added to product labeling. Posted 01/13/2012
• December 2011 Monthly Safety Labeling Changes includes 40 products with revisions to Prescribing Information. Posted 01/12/2012
• CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure UPDATED 01/12/2012. FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82. Originally posted 07/15/2011
• Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient Failure of therapy could result in the potential for harm or death of a ventilator-dependent patient. Posted 01/12/2012
• Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles Particulate matter in injections can be harmful when introduced into the bloodstream. Posted 01/12/2012
• Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk A packaging problem may result in a pill, tablet or caplet getting mixed in with a different prescription. Posted 01/09/2012
• Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps Consumers are asked to either destroy or return unused product identified in the recall to Novartis. Posted 01/09/2012
• Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death. Posted 01/04/2012