What's New Archive, Jan 01 - Dec 31 2011

• CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation Ventilator may stop ventilating and result in life-threatening injury or death. Posted 12/23/2011
• Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors Additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available. Posted 12/22/2011
• Eclectic Institute Dietary Supplements: Recall - Possible Salmonella Contamination Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Posted 12/22/2011
• ShoulderFlex Massager: Warning - Risk of Strangulation Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation. Posted 12/21/2011
• St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation Premature insulation abrasion may cause the conductors to become externalized, which can cause serious adverse health consequences, including death. Posted 12/21/2011
• 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
• Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events UPDATED 12/19/2011. FDA completed safety review, issued new recommendations. Originally posted 07/21/2011
• Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations [UPDATED 12/15/2011] FDA revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. Originally posted 06/08/2011
• Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn Conflicting results from different studies makes it premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. Posted 12/14/2011
• November 2011 Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information. Posted 12/12/2011
• Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review UPDATED 12/12/2011. Safety Review Update. Continue to prescribe drugs used for the treatment of ADHD according to the professional prescribing directions. Originally posted 06/15/2009
• CooperVision AVAIRA Toric and Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on Lenses UPDATED 12/09/2011. Expansion of recall. Symptoms may range from hazy, blurry vision and discomfort, to eye injuries requiring medical treatment. Originally posted 10/14/2011
• Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events UPDATED 11/02/2012. Results of FDAs Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin. Originally posted 12/07/2011
• October 2011 Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information. Posted 11/18/2011
• ShoulderFlex Massager by King International: Safety Communication - Risk of Strangulation UPDATED 11/17/2011. Class I Recall issued. Hair, clothing, and jewelry can become entangled in the massage device and cause serious injury or death. Originally posted 08/26/2011
• Virility Max: Recall - Undeclared Drug Ingredient Product marketed as dietary supplement contains sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 011/14/2011
• Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury Potential for patient falls or unanticipated patient movement, which may result in serious injury or death. Posted 11/09/2011
• Trilipix (fenofibric acid): Drug Safety Communication - Label Change The ACCORD Lipid trial found no significant difference in the risk of a major adverse cardiac event between group treated with fenofibrate plus simvastatin compared with simvastatin alone. Posted 11/09/2011
• CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. Posted 11/04/2011
• Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults UPDATED 11/04/2011. FDA is asking health professionals to remain vigilant for cases of malignancy in patients treated with TNF blockers and report them to MedWatch. Originally posted 04/14/2011
• Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review UPDATED 12/12/2011. Safety Review Update. Continue to prescribe drugs used for the treatment of ADHD according to the professional prescribing directions. Originally posted 06/15/2009
• Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots UPDATED 10/27/2011. FDA is continuing its review of the potential increased risk of blood clots with the use of birth control pills containing drospirenone. Originally posted 05/31/2011
• Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock. Posted 10/25/2011
• Chantix (varenicline) UPDATED 10/24/2011. Updated study data. Healthcare professionals should continue to monitor patients for neuropsychiatric symptoms. Originally posted 11/20/2007
• Nostrilla Nasal Decongestant: Recall - Bacterial Contamination Burkholderia cepacia bacteria may cause serious infection in individuals with a compromised immune system or chronic lung condition. Posted 10/21/2011
• Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications UPDATED 10/21/2011. Not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with linezolid. Most cases occurred in patients taking an SSRI or SNRI. Posted 07/26/2011
• Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications UPDATED 10/21/2011. Not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with methylene blue. The cases of serotonin syndrome occurred in patients taking an SSRI, SNRI, or clomipramine. Originally posted 07/26/2011
• CooperVision AVAIRA Toric and Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on Lenses UPDATED 12/09/2011. Expansion of recall. Symptoms may range from hazy, blurry vision and discomfort, to eye injuries requiring medical treatment. Originally posted 10/14/2011
• September 2011 Monthly Safety Labeling Changes includes 34 products with revisions to Prescribing Information. Posted 10/14/2011
• Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel, as well as during treatment. Posted 10/11/2011
• Uprizing 2.0: Recall - Undeclared Drug Ingredient: Synthetic Steroid Product marketed as testosterone booster contains superdrol, a synthetic steroid. Use of synthetic anabolic steroids may cause serious long-term adverse health consequences. Posted 10/06/2011
• 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
• Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots UPDATED 10/27/2011. FDA is continuing its review of the potential increased risk of blood clots with the use of birth control pills containing drospirenone. Originally posted 05/31/2011
• Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error Daily regimen may be incorrect and could leave women without adequate contraception. Posted 09/16/2011
• Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms Avoid use of ondansetron in patients with congenital long QT syndrome, and monitor those with electrolyte abnormalities, CHF, bradyarrhythmias, or those taking concomitant medications that prolong the QT interval. Posted 09/15/2011
• Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance Potential for reduced battery performance can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms. Posted 09/12/2011
• Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria Patients treated with TNFα blockers are at increased risk for developing serious infections. Posted 09/07/2011
• Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions Reports of hypersensitivity reactions, including anaphylaxis (a life-threatening allergic reaction), angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash. Posted 09/01/2011
• Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment Reclast should not be used in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. Posted 09/01/2011
• ShoulderFlex Massager by King International: Safety Communication - Risk of Strangulation UPDATED 11/17/2011. Class I Recall issued. Hair, clothing, and jewelry can become entangled in the massage device and cause serious injury or death. Originally posted 08/26/2011
• H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing [UPDATED 09/25/2012] Custom Medical Specialties, Inc., HSG Tray, Hysteroscopic Sterilization Pack, Vein Tray, Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, CT Biopsy Tray, Myelogram Tray, and Hysteroscopy Sterile Procedure...
• Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses Citalopram should no longer be prescribed at doses greater than 40 mg per day. Posted 08/24/2011
• July 2011 Monthly Safety Labeling Changes includes 32 products with revisions to Prescribing Information. Posted 08/11/2011
• Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer UPDATED 08/04/2011. Updated drug labels for pioglitazone-containing medicines, should not be used in patients with active bladder cancer. Originally posted 09/17/2010
• Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death UPDATED 08/04/2011. Evidence regarding recombinant human growth hormone and increased risk of death is inconclusive. Originally posted 12/22/2010
• Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency Some vials may not maintain potency throughout their shelf-life, which may lead to reduced effectiveness. Posted 08/04/2011
• GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH): Class I Recall HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient. Posted 08/03/2011
• Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall Reports of breakage and/or separation of the stylet. Posted 08/03/2011
• Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects Pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. Posted 08/03/2011
• GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall - Innaccurate Results Potassium test results too low when compared to a reference analyzer, which may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death. Posted 08/01/2011
• Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel: Public Notification - Undeclared Drug Ingredient UPDATED 07/27/2011. Intercharm Inc. is recalling Slimforte Slimming Capsules, Slimforte Slimming Coffee, and Meizitang Botanical Slimming Soft Gel to the consumer/user level. Originally posted 07/08/2011
• Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall - Biohazardous Materials May be Released Potential for Centrifuge bucket and insert not being seated on the rotor, breaking the lid and being forced out of the centrifuge, which may result in serious personal injury and damage to the surrounding area. Posted 07/27/2011
• 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
• Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications UPDATED 10/21/2011. Not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with linezolid. Most cases occurred in patients taking an SSRI or SNRI. Posted 07/26/2011
• Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications UPDATED 10/21/2011. Not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with methylene blue. The cases of serotonin syndrome occurred in patients taking an SSRI, SNRI, or clomipramine. Originally posted 07/26/2011
• Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events UPDATED 07/22/2011. Label updated with new information for populations who may benefit from giving up smoking. Originally posted 06/16/2011
• Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events UPDATED 12/19/2011. FDA completed safety review, issued new recommendations. Originally posted 07/21/2011
• Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer FDA is reviewing data from published studies to evaluate risk of cancer of the esophagus. Posted 07/21/2011
• 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.
• 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
• June 2011 Monthly Safety Labeling Changes includes 50 products with revisions to Prescribing Information. Posted 07/14/2011
• Transvaginal Placement of Surgical Mesh [UPDATED 07/13/2011] Warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options. [Originally Posted 10/21/2008]
• Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL) Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012). Posted 07/11/2011
• Slim Forte Slimming Capsule and Slim Forte Double Power Slimming Capsules: Public Notification - Undeclared Drug Ingredient Products marketed as dietary supplements contain sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 07/08/2011
• Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel: Public Notification - Undeclared Drug Ingredient UPDATED 07/27/2011. Intercharm Inc. is recalling Slimforte Slimming Capsules, Slimforte Slimming Coffee, and Meizitang Botanical Slimming Soft Gel to the consumer/user level. Originally posted 07/08/2011
• Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS) Increased Risk of Post-transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML). Posted 07/07/2011
• Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy) Benefits and risks of valproate sodium and related products should be carefully weighed when prescribing these drugs to women of childbearing age. Posted 06/30/2011
• Tylenol Extra Strength Caplets, 225 count bottles: Recall - Uncharacteristic Odor One lot recalled due to the presence of trace amounts of a 2,4,6-tribromoanisole (TBA), which has been associated with temporary and non-serious gastrointestinal symptoms. Posted 06/29/2011
• Nature Relief Instant Wart and Mole Remover: Recall - Risk of Severe Skin Burns Active ingredient calcium oxide can cause severe burns, particularly to areas of thin or sensitive skin such as the face, around the eyes, and genitalia. Posted 06/27/2011
• Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets Risk of increase of acetaminophen dose, which may result in liver toxicity, especially in patients on other acetaminophen containing medications. Posted 06/27/2011
• Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled Recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone. Posted 06/27/2011
• Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations Increased risks of cardiovascular events using ESAs in this patient population. Posted 06/24/2011
• Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor Two lots recalled. Contamination thought to be the result of a chemical preservative applied to wood used in the construction of pallets on which materials are transported and stored. Posted 06/20/2011
• Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy Failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent. Posted 06/17/2011
• Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events UPDATED 07/22/2011. Label updated with new information for populations who may benefit from giving up smoking. Originally posted 06/16/2011
• 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.
• Indomethacin for Injection: Recall of One Lot - Particulate Matter Particulate matter may provoke an immune reaction and/or lead to microinfarcts which could be serious and life threatening. Posted 06/15/2011
• Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer UPDATED 08/04/2011. Updated drug labels for pioglitazone-containing medicines, should not be used in patients with active bladder cancer. Originally posted 09/17/2010
• May 2011 Monthly Safety Labeling Changes includes 47 products with revisions to Prescribing Information. Posted 06/15/2011
• Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient Risk of embolization causing tissue and blood vessel injury, heart attack or other serious events. Posted 06/14/2011
• Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize Risk of arterial injury, hemorrhaging, or other serious events. Posted 06/14/2011
• Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning Consequences may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events. Posted 06/14/2011
• Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors - Name Confusion Healthcare Professionals reminded to clearly print or spell out the medication name on prescriptions. Posted 06/13/2011
• Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis Reminder: Victoza not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Posted 06/13/2011
• 5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer Two large, randomized controlled trials showed an increased incidence of high-grade prostate cancer with finasteride and dutasteride treatment. Posted 06/09/2011
• Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations [UPDATED 12/15/2011] FDA revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. Originally posted 06/08/2011
• Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination UPDATE 06/08/2011. Churchill Medical Systems/Vygon recalled Skin-Prep Wipes used in Convenience Kits. Use of contaminated alcohol prep pads, alcohol swabs or alcohol swabsticks could lead to life-threatening infections. Original post 01/06/2011
• Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men: Recall - Undeclared Drug Ingredient Product contains analogs of Sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 06/07/2011
• Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient Inhalation of the plastic strands may cause respiratory compromise, which could result in serious illness or death. Posted 06/07/2011
• 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.
• SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition [UPDATED 09/18/2012] FDA Expands Caution About SimplyThick. Originally posted 05/20/2011.
• Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products Potential for serious anaphylactic reaction in patients with known hypersensitivity to beta-lactam or penicillin products. Posted 06/03/2011
• Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication Thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. Posted 06/02/2011
• Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed No increase in risk of cancer with ARB blood pressure drugs. Posted 06/02/2010
• Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots UPDATED 10/27/2011. FDA is continuing its review of the potential increased risk of blood clots with the use of birth control pills containing drospirenone. Originally posted 05/31/2011
• Slim Xtreme Herbal Slimming Capsule: Undeclared Drug Ingredient All 30 Capsules/Bottle lots are being recalled. Affected product contains undeclared sibutramine. Originally posted 05/11/2011
• Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall - Incorrect Electrolyte Results Errors may be the result of ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, and instrument maintenance. Posted 05/23/2011
• Pentrexyl Forte Natural: Recall - Misleading Packaging Dietary supplement product packaging may cause it to be confused with an antibiotic product. Posted 05/23/2011
• SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition [UPDATED 09/18/2012] FDA Expands Caution About SimplyThick. Originally posted 05/20/2011.
• Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events UPDATED 05/18/2011. New restrictions to the prescribing and use of rosiglitazone-containing medicines, including Avandia, Avandamet, and Avandaryl. Originally posted 09/23/2010
• ExtenZe Tablets: Recall UPDATED 05/16/2011. Additional counterfeit product lots recalled. Counterfeit dietary supplement contains undeclared drug ingredients which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure,...
• Slim Xtreme Herbal Slimming Capsule: Undeclared Drug Ingredient All 30 Capsules/Bottle lots are being recalled. Affected product contains undeclared sibutramine. Originally posted 05/11/2011
• Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock Defect may result in failure to resuscitate the patient. Posted 05/11/2011
• Multi-Mex Distributor Inc. Dietary Supplements: Recall - Product Packaging Mimics OTC Antibiotics FDA inspection revealed products mimic antibiotics readily available in Mexico and possibly familiar to Hispanic consumers. Posted 05/10/2011
• Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems UPDATED 05/06/2011. Syringes may malfunction, break, or become clogged during the process of attempting to connect to some needleless IV access systems. Originally posted 11/18/2010
• 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.
• Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy Clips may become dislodged, which can lead to uncontrolled bleeding, additional surgery, or death of the donor. Posted 05/06/2011
• Boston Scientific Devices Stolen – Risk of Infection Labels on these devices state that they are “Sterile”; however, they were stolen prior to being sterilized and are non-sterile. Posted 05/04/2011
• VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP): Recall - Incorrect Test Results Observed UPDATED 05/03/2011. Expanded Recall. Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death. Originally posted 11/10/2010
• 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
• Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency Increased risk of bleeding if there is too much active ingredient in tablet. Posted 05/03/2011
• 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
• 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.
• Tysabri (natalizumab): Update of Healthcare Professional Information UPDATED 04/22/2011 Label provides new information about the size of the risk of PML, rates of PML according to number of infusions and association of risk with other drugs that suppress immune system.
• Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements UPDATED 04/15/2011. FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs). Originally posted 02/18/2010
• Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding Tubes Tablets may not fully disintegrate when water is added, and/or they may disintegrate but later form clumps which can adhere to the inside walls of oral syringes and feeding tubes. Posted 04/15/2011
• Topamax (topiramate): Recall - Musty Odor Two lots of topiramate 100mg tablets recalled, reports of temporary gastrointestinal symptoms. Posted 04/15/2011
• Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults UPDATED 11/04/2011. FDA is asking health professionals to remain vigilant for cases of malignancy in patients treated with TNF blockers and report them to MedWatch. Originally posted 04/14/2011
• Benicar (olmesartan): Ongoing Safety Review UPDATED 04/14/2011. The benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Originally posted 06/11/2010
• Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Coil Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke. Posted 04/13/2011
• Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall- Product May Shed Particles of Tungsten After use for IORT in breast tissue, these particles can be mistaken for suspicious calcifications during follow up X-rays or scans. Posted 04/13/2011
• March 2011 Monthly Safety Labeling Changes includes 55 products with revisions to Prescribing Information. Posted 04/12/2011
• 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
• Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products. Posted 04/07/2011
• Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions The most common severe reactions include enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. Posted 04/06/2011
• Best Enhancer: Recall – Undeclared Drug Ingredient Products marketed as dietary supplements contain undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 04/05/2011
• Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall - Insufficient Adhesive The deployment tube may detach during use and may result in the failure of the product to operate, This may cause serious injury and/or death. Posted 04/01/2011
• Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall Small particles (debris) may be found inside the catheter and potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs which can result in serious injury and /or death. Posted 04/01/2011
• Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama Hospitals Use of contaminated products may lead to bacterial infection of the blood. Posted 03/30/2011
• Pradaxa (dabigatran etexilate mesylate) Capsules: Special Storage and Handling Requirements Potential for product breakdown and loss of potency if not dispensed and stored in the original bottle or blister package. Posted 03/30/2011
• X-Hero and Male Enhancer: Recall - Undeclared Drug Ingredient Products marketed as dietary supplement contain drug ingredients sulfosildenafil or tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 03/29/2011
• Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall - Potential for Under-Delivery of Insulin Use of recalled product can result in elevated blood glucose levels (hyperglycemia), which can lead to serious health complications including death.
• Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A and D Reports of consumers experiencing decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea. Posted 03/29/2011
• Celerite Slimming Tea: Recall - Undeclared Drug Ingredient Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 03/28/2011
• Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant Non-sterility of a chemotherapeutic product administered via the intravenous route has the potential to result in infections which could be fatal, especially in patients who are immunocompromised. Posted 03/28/2011
• Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling Bottles labeled as citalopram may contain finasteride. Posted 03/28/2011
• U-Prosta: Undeclared Drug Ingredient Product marketed as dietary supplement contains terazosin, adverse health consequences that could occur with the use of this product would be hypotension, dizziness, or syncope. Posted 03/24/2011
• Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination UPDATE 06/08/2011. Churchill Medical Systems/Vygon recalled Skin-Prep Wipes used in Convenience Kits. Use of contaminated alcohol prep pads, alcohol swabs or alcohol swabsticks could lead to life-threatening infections. Original post 01/06/2011
• Proton Pump Inhibitors (PPI): Class Labeling Change UPDATED 03/23/2011 FDA determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication “Drug Facts” label is not indicated at this time. Originally Posted 05/25/2010
• 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
• 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.
• Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test and, AccuProbe Mycobacterium Avium Complex Culture Identification Test: Class I Recall Possible false-negative results may occur. This may cause serious adverse consequences and/or death. Posted 03/17/2011
• February 2011 Monthly Safety Labeling Changes includes 53 products with revisions to drug Prescribing Information. Posted 03/16/2011
• Black Ant: Undeclared Drug Ingredient Product marketed as dietary supplement contains Sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 03/16/2011
• Kaletra (lopinavir/ritonavir): Label Change - Serious Health Problems in Premature Babies New Warning about serious heart, kidney, or breathing problems which can be fatal. Posted 03/08/2011
• Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns Increased risk of oral clefts in infants born to women treated with Topamax (topiramate) during pregnancy. Posted 03/04/2011
• Davol XenMatrix Surgical Graft: Class I Recall - Elevated Endotoxin Levels Endotoxins in product can cause serious illness, at times fatal. Posted 03/04/2011
• Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays: Class I Recall - Leaks in Plunger Luer Detected Leakage and possible loss of sterility, which may lead to serious adverse health consequences and/or death. Posted 03/03/2011
• Unapproved Cough, Cold, Allergy Products: FDA Prompts Removal From Market Unapproved products have not been evaluated by the FDA for safety, effectiveness, and quality. Posted 03/02/2011
• Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term Use Prolonged treatment with prescription PPIs may lead to low serum magnesium levels, which can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures). Posted 03/02/2011
• Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack FDA meta-analysis of clinical trials did not show an increased risk of MI associated with the use of abacavir. Posted 03/01/2011
• Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification UPDATED 02/28/2011. Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT. Originally posted 11/16/2009
• Svelte 30: Recall - Undeclared Drug Ingredient Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 02/25/2011
• ExtenZe Tablets: Recall UPDATED 05/16/2011. Additional counterfeit product lots recalled. Counterfeit dietary supplement contains undeclared drug ingredients which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure,...
• Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns Risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs. Posted 02/22/2011
• Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage UPDATED 02/21/2011. Expansion of Recall: Affected Products Include Amantadine, Amlodipine,Androxy,Baclofen, Bethanechol, Jantoven and Oxybutynin. Originally Posted 02/17/2011
• Terbutaline: Label Change - Warnings Against Use for Treatment of Preterm Labor Potential for serious maternal heart problems and death. Posted 02/17/2011
• January 2011 Monthly Safety Labeling Changes includes 43 products with revisions to drug Prescribing Information. Posted 02/17/2011
• Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall Recall due to pocket fills may result in patient harm, serious injury, and/or death due to drug overdose or underdose. Posted 02/16/2011
• Triad Sterile Lubricating Jelly: Recall - Product May Not Be Sterile Patients who are immuno-compromised may be at potential risk for infection. Posted 02/16/2011
• Arstasis One Access System: Class I Recall - Components May Fracture and/or Separate Use of recalled product may lead to patient harm. Posted 02/09/2011
• Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling Patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital, which can lead to serious adverse events. Posted 02/07/2011
• Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use Use of recalled product may lead to arterial injury, hemorrhaging, blood clots (thrombosis), or other serious events. Posted 02/04/2011
• Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events UPDATED 05/18/2011. New restrictions to the prescribing and use of rosiglitazone-containing medicines, including Avandia, Avandamet, and Avandaryl. Originally posted 09/23/2010
• B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive Software update may cause normal operation to stop with no visual warning signal. Posted 02/01/2011
• Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men: Recall - Undeclared Drug Ingredient Products marketed as dietary supplements contain Sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 01/27/2011
• Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath UPDATED 01/27/2011. Additional model & lot numbers added. Arrow Intra-Aortic Balloon (IAB) Catheter Products can become stuck in the sheath and potential to cause delay in therapy, bleeding or arterial injury. Originally posted 12/29/2010
• Breast Implants: FDA Review Indicates Possible Association With A Rare Cancer Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant. Posted 01/26/2011
• Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor: Class I Recall - Potential for Kinking of Arterial Line Kinking can cause the destruction of red blood cells which may result in serious injury and/or death. Posted 01/21/2011
• Multaq (dronedarone) - Drug Safety Communication: Risk of Severe Liver Injury Reports include two cases of liver failure leading to liver transplant. Posted 01/14/2011
• December 2010 Monthly Safety Labeling Changes includes 58 products with revisions to drug Prescribing Information. Posted 01/14/2011
• Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication New labeling changes to emphasize the potential for severe liver failure and serious allergic reactions. Posted 01/13/2011
• Celerite Slimming Capsules: Undeclared Drug Ingredient Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 01/13/2011
• Lantus (insulin glargine) UPDATED 01/12/2011. FDA is updating the public about its ongoing safety review of Lantus and a possible increased risk of cancer. At this time, FDA has not concluded that Lantus increases the risk of cancer. Originally posted 07/01/2009
• Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose Morphine sulfate oral solution ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. Posted 01/10/2011
• Metronidazole Tablets, 250mg: Recall - Underweight Tablets Tablets may not contain the full amount of active ingredient, which may cause the infection the drug was intended to treat to worsen or recur, which could be life-threatening when treating severe infections. Posted 01/06/2011
• AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall Use of affected devices may lead to retained device fragments or significant arterial injury which may lead to death or need for additional surgical intervention. Posted 01/05/2011
• Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials Potential for dosing error leading to albuterol toxicity. Posted 01/03/2011
• Fruta Planta: Public Notification - Undeclared Drug Ingredient UPDATED 01/03/2011 - FDA Press Release link added. Product marketed as a dietary supplement contains sibutramine, a controlled substance known to substantially increase blood pressure and/or pulse rate. Posted 12/23/2010
• Rock Hard Extreme and Passion Coffee by Drive Total Energy: Recall - Undeclared Drug Ingredient Products marketed as dietary supplements contain undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 01/03/2011
• Acetadote (acetylcysteine) Injection: Recall - Particulate Matter Found in a Small Number of Vials 6 lots of Acetadote is being recalled as a precautionary measure based on observed particulate matter found in a small number of vials. Posted 01/01/2011