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Recalls and Safety Alerts: Warning on Tendon Injuries with Fluoroquinolone Antibiotics

Wed, 2008-10-01 04:00
FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon r...
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Recalls and Safety Alerts: CT Scanning May Cause Malfunction of Electronic Medical Devices

Wed, 2008-10-01 04:00
FDA is alerting healthcare professionals that the x-rays emitted during CT exams may cause some electronic medical devices to malfunction. These malfunctions are different from those related to MRI scanning, which are caused by strong electrical and...
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Recalls and Safety Alerts: Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents

Wed, 2008-10-01 04:00
FDA is alerting healthcare professionals about labeling changes for ultrasound micro-bubble contrast agents, which are sold as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injec...
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Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone

Wed, 2008-10-01 04:00
FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis ...
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Recalls and Safety Alerts: Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine

Wed, 2008-10-01 04:00
FDA is alerting healthcare professionals about reports of life-threatening complications from the use of recombinant human Bone Morphogenetic Protein (rhBMP) in cervical spine fusion. Although FDA has approved two rhBMP products for very specific me...
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Preventing Medical Errors: Potentially Fatal Glucose Monitoring Errors with Icodextrin

Wed, 2008-10-01 04:00
The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include oral xylose, parenterals that contain ma...
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Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008)

Mon, 2008-09-01 04:00
This story originally aired in April 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. The Institute for Safe Medication Practices (ISMP) recently des...
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Recalls and Safety Alerts: Severe Pain with Osteoporosis Drugs (March 2008)

Mon, 2008-09-01 04:00
This story originally aired in March 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is alerting healthcare professionals that severe bone, join...
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Recalls and Safety Alerts: Preventing Meningitis in Children with Cochlear Implants (December 2007)

Mon, 2008-09-01 04:00
This story originally aired in December 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is reminding healthcare practitioners about the importan...
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Preventing Medical Errors: More Patient Deaths from Luer Misconnections (October 2007)

Mon, 2008-09-01 04:00
This story originally aired in October 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the publication "Safe Practices in Pa...
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Preventing Medical Errors: Preventing Patient Deaths from Fentanyl Patches (September 2007)

Mon, 2008-09-01 04:00
This story originally aired in September 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent report from the Institute for Safe Medication Prac...
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Preventing Medical Errors: What to Do about Unretrieved Device Fragments (January 2008)

Mon, 2008-09-01 04:00
This story originally aired in January 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. A recent FDA article in the journal Nursing2007 alerts health...
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Recalls and Safety Alerts: Warning Added to Regranex Label

Fri, 2008-08-01 04:00
A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers. Based on a review of an ea...
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Recalls and Safety Alerts: Cellcept and Myfortic Linked to Birth Defects and Fetal Loss

Fri, 2008-08-01 04:00
FDA is advising healthcare professionals about an increased risk of fetal harm when women become pregnant while being treated with the immunosuppressant drugs Cellcept (mycophenolate mofetil) or Myfortic (mycophenolic acid). Myfortic is approved t...
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Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer

Fri, 2008-08-01 04:00
FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ...
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Preventing Medical Errors: Danger Giving Topical Thrombin Intravascularly

Fri, 2008-08-01 04:00
The Institute for Safe Medication Practices (ISMP) recently warned about the dangers of accidentally giving topical thrombin intravascularly. Thrombin applied topically can help stop oozing blood and minor bleeding from capillaries and small veins. ...
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Preventing Medical Errors: Potential Problems with Insulin Pens in Hospitals

Fri, 2008-08-01 04:00
In a recent article, the Institute for Safe Medication Practices (ISMP) highlighted several potential safety problems when hospitals switch from multiple dose vials of insulin to insulin pens. ISMP points out that there are certain safety advant...
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FDA Consumer Corner: Nonoxynol 9 Contraceptives: No Protection against HIV and Other STDs

Fri, 2008-08-01 04:00
The Food and Drug Administration wants to be sure that consumers know about new warnings on over-the-counter vaginal contraceptive products that contain the spermicide ingredient nonoxynol 9 (N9). These products include spermicidal gels, foams, film...
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New Medical Products: New Skin Graft Adhesive Approved

Tue, 2008-07-01 04:00
FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi...
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New Medical Products: New Non-Refrigerated Coagulation Product

Tue, 2008-07-01 04:00
FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with...
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