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  • 2-Channel Infusion Pump Mix-up
    The Institute for Safe Medication Practices (ISMP) recently reported on a medication mix-up with the use of a two-channel infusion pump.
    FDA · 2003-09-01 · 初级
  • Food Labeling Adds Trans Fat Info
    FDA has issued a new regulation that requires food manufacturers to list the amount of trans fatty acids on the Nutrition Facts panel of the product label.
    FDA · 2003-09-01 · 初级
  • West Nile Virus Test Cleared
    The FDA has cleared the first test to help diagnose West Nile virus infection in patients with suspected symptoms of the disease.
    FDA · 2003-09-01 · 初级
  • Safe Medication Use Promoted
    A new brochure published by the Agency for Healthcare Research and Quality (AHRQ) helps consumers use medications safely.
    FDA · 2003-08-01 · 初级
  • Patient Literacy Challenges
    The Institute for Safe Medication Practices has cautioned that many patients have difficulty reading, which makes it harder for them to fully comprehend medical documentation.
    FDA · 2003-08-01 · 初级
  • Aspergillus Infection Rapid Test
    FDA has cleared for marketing the first rapid laboratory test for invasive Aspergillus infection, with results available much faster than the standard culture method of testing for Aspergillus.
    FDA · 2003-08-01 · 初级
  • First Intranasal Flu Vaccine
    FDA has approved MedImmune's intranasal flu vaccine FluMist for U.S. marketing. It contains the three influenza virus strains recommended by the U.S. Public Health Service for the upcoming flu season.
    FDA · 2003-08-01 · 初级
  • BP Monitor/IV Port Misconnections
    The Institute for Safe Medication Practices (ISMP) has reported on a number of cases where the tubing from a patient's blood pressure monitor was mistakenly connected to the IV port.
    FDA · 2003-08-01 · 初级
  • AZN's NSCLC Drug Iressa Drops
    FDA · 2003-08-01 · 初级
  • Pediatric Depression Paxil Caution
    FDA is reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents being treated with Paxil for major depressive disorder.
    FDA · 2003-08-01 · 初级
  • TD/PPD Vaccine Mix-ups
    The Institute for Safe Medication Practices (ISMP) has reported on mix-ups between tetanus/diphtheria toxoid (Td) vaccine, and tuberculin PPD (purified protein derivative).
    FDA · 2003-07-01 · 初级
  • Surgical Handpiece Burn Risks
    FDA has received reports of patient burns when rotary surgical handpieces overheated, some of which were serious enough to require plastic surgery.
    FDA · 2003-07-01 · 初级
  • Syringe Stopper Cell Inhibition
    FDA has reported on cell growth inhibition in amniocentesis cell cultures, which can happen when amniotic fluid isn't transferred quickly from the collection syringe to the transport tube.
    FDA · 2003-07-01 · 初级
  • Orphan Disease Act Brings Relief
    FDA has approved three new products used to treat rare conditions, including Genzyme's Fabrazyme (agalsidase beta) to treat Fabry disease, and Aldurazyme (laronidase) to treat Hurler syndrome.
    FDA · 2003-07-01 · 初级
  • Sirolimus-Eluting Coronary Stent
    In a recent news release, FDA announced the approval of a new drug-eluting stent for angioplasty. The device is called the Cypher Sirolimus Eluting Coronary Stent, and it's manufactured by Cordis Corpor
    FDA · 2003-07-01 · 初级
  • Updated FDA Web Pages
    The FDA has updated several of its web pages, including the one for SARS (severe acute respiratory syndrome).
    FDA · 2003-07-01 · 初级
  • Counterfeit Lipitor Recall
    FDA is alerting healthcare providers and patients about a recall of several lots of Pfizer's cholesterol-lowering drug Lipitor (atorvastatin).
    FDA · 2003-07-01 · 初级
  • Fatal Temodar Dosing Errors
    FDA has received several reports of serious medication errors, some of them fatal, with the drug Temodar, manufactured by Merck.
    FDA · 2003-07-01 · 初级
  • Aerocrine Exhales Asthma Test
    FDA announced that it has cleared Aerocrine's "NIOX" Nitric Oxide Test System to help monitor an asthma patient's response to anti-inflammatory treatment.
    FDA · 2003-07-01 · 初级
  • Expanded HPV Test Utilization
    FDA has approved the expanded use of a laboratory test to detect sexually-transmitted human papillomavirus (HPV) in the uterine cervix.
    FDA · 2003-06-01 · 初级
  • Defective Glucose Test Strip Vials
    Roche Diagnostics has issued an urgent product correction on some of its Accu-Chek glucose test strips because of a defect that could allow moisture to cause inaccurate results.
    FDA · 2003-06-01 · 初级
  • Fetal Pulse Oximeter Safety
    FDA has received over a dozen reports of poor neonatal outcomes associated with the use of the Nellcor [Covidien] OxiFirst fetal pulse oximetry system.
    FDA · 2003-06-01 · 初级
  • Beta Interferon MS Caution
    The prescribing information for three brands of beta interferon used to treat multiple sclerosis now contains new information and strengthened warnings on adverse reactions.
    FDA · 2003-06-01 · 初级
  • Emend Combats Chemo Nausea
    FDA has approved Merck's antiemetic drug Emend (aprepitant) to prevent nausea and vomiting in chemotherapy patients.
    FDA · 2003-06-01 · 初级
  • Gynecare Intergel Withdrawal
    The Gynecare Intergel adhesion prevention solution, which reduces post-surgical adhesions in patients undergoing open gynecologic surgery, has been voluntarily withdrawn from the market.
    FDA · 2003-06-01 · 初级
  • Scabies & Lice Lindane Risk
    FDA has warned health professionals about the potential toxicity of lindane when it's used to treat scabies and lice, reporting neurologic effects ranging from dizziness to seizures.
    FDA · 2003-06-01 · 初级
  • Fusion Inhibitors Targeting HIV
    FDA has approved "fusion inhibitors" to treat advanced HIV-1 infection in adults and children aged six and older.
    FDA · 2003-06-01 · 初级
  • Roche Glucose Strip Calibration Alert
    Roche Diagnostics has alerted healthcare providers that certain glucose test strips intended only for distribution outside the U.S. have been improperly repackaged and re-imported into the U.S.
    FDA · 2003-05-01 · 初级
  • Drug Label Antibiotic Resistance Info
    The CDC has noted that about 50 million antibiotic prescriptions written in U.S. physicians' offices annually are unnecessary, because they're prescribed for the common cold and other viral infections.
    FDA · 2003-05-01 · 初级
  • Albumin Cobalt Test Precludes MI
    FDA has cleared for marketing the Albumin Cobalt Binding Test, which will increase the ability to rule out a possible heart attack in patients complaining of chest pain.
    FDA · 2003-05-01 · 初级