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FDA: Medical Watch
FDA MedWatch Safety Alerts
Updated: 14 hours 14 min ago
Abiomed AB5000 Circulatory Support System: Class I Recall
Device computer may shut down without an alarm, which can lead to serious injuries or death.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis
Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall
UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall
Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
OneTouch SureStep Test Strips (LifeScan): Recall
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
StatSpin Express 4 Centrifuges Model 510: Class I Recall
Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Invirase (saquinavir): Ongoing safety review of clinical trial data
Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Ear Candles: Risk of Serious Injuries
Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
FDA requires risk management plan and class-labeling changes for all LABAs.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Exjade (deferasirox): Boxed Warning
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
BD Q-Syte Luer Access Devices: Recall
Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall
Device may not be able to deliver therapy during a cardiac resuscitation attempt.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
BD Q-Syte Luer Access Devices: Recall
Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Tysabri (Natalizumab): Update of Healthcare Professional Information
Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Tysabri (Natalizumab): Update of Healthcare Professional Information
Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Categories: NEWS: U.S. Food and Drug Administration (FDA)