Archive | March, 2010
Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review
FDA is evaluating clinical trial data that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer.
Continue reading...Boston Scientific Implantable Cardioverter Defibrillators: Recall
19. March 2010
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Practitioners should not use these devices unless and until FDA reviews and approves changes made by the manufacturer.
Continue reading...Zocor (simvastatin): increased risk of muscle injury with high doses
19. March 2010
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Ongoing review shows risk also increased when drug, especially at higher doses, is used with certain drugs.
Continue reading...Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall
18. March 2010
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Defective devices may result in air bubbles leaking into the infusion system and into the patient’s bloodstream.
Continue reading...Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall
16. March 2010
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Device implanted for ventilation or drainage of the middle ear - shipped without being sterilized.
Continue reading...Cleviprex (clevidipine butyrate): Recall
16. March 2010
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The recall of 12/2009 has been expanded to include four additional lots. Presence of particulate matter which could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.
Continue reading...Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug
12. March 2010
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Boxed warning added regarding reduced effectiveness of Plavix in poor metabolizers.
Continue reading...Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall
11. March 2010
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Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Continue reading...Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
11. March 2010
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FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
Continue reading...Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall
11. March 2010
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Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.
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31. March 2010
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