MedWatch: The FDA Safety Information and Adverse Event Reporting Program
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
What's New
- Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions.[08/08/2018]
- Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes. [08/03/2018]
- Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Productsrelated to the NDMA impurity detected in the valsartan. [07/19/2018]
- Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. [07/10/2018]
- Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination via sample testing and finding to have salmonella that can cause can cause serious and sometimes fatal infections.[06/22/2018]
- Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems. [Posted 06/19/2018]
- Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections during cataract surgery. Patients experienced various symptoms, including vision impairment.[Posted 06/14/2018]
- CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy The fluid can cause corrosion of internal components and lead to device malfunction which can cause a delay or interruption in therapy. [Posted 06/06/2018]
- Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary (emboli, dysfunction or infarction), and toxicity. [Posted 06/04/2018]
- Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices. [06/04/2018]
- HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death. [Posted 06/01/2018]
- STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings: Recall - Patient Port May Detach During Use The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use. [Posted 06/01/2018]
FDA Approved Safety Information
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